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Shrinking Boundary of the Invisible Hand. The Macroeconomic Implications of Limited Arbitrage. Gross Worker Flows over the Life Cycle. Job Displacement, Remarriage, and Marital Sorting. Firms' Expectations and Monetary Policy Shocks. Time Aggregation in Health Insurance Deductibles.

Welfare Consequences of Nominal Excise Taxation. Credit Horizons. Knowledge Cycles and Corporate Investment. Cecilia Bustamante , University of Maryland. Job Ladder and Business Cycles. Learning on the Job and the Cost of Business Cycles. Cyclical Wages and Labor Market Sorting. The Constraint on Public Debt When r. Conserving Fiscal Space. Quantitative Easing and Inequality. Female Labor Supply and Jobless Recovery.

Public employment and women's labor market outcomes. Inequality and the Zero Lower Bound. Deep Equilibrium Nets. Trade, Technology, and Agricultural Productivity. Multinationals and Structural Transformation. National institutions and self-insurance.

Are Routine Jobs Moving South? A Multisector Perspective of Wage Stagnation. Routine-biased technological change, structure of employment, and cross-country income differences. The Liquidity Channel of Fiscal Policy. Marginal Tax Changes with Risky Investment. Consumer Learning and Firm Dynamics. The monetization of innovation. Testing the effectiveness of unconventional monetary policy in Japan and the United States.

Pandemic Recessions and Contact Tracing. Evaluating the Effectiveness of Policies Against a Pandemic. Investment Externalities in Models of Fire Sales. Trade Globalization and the Labor Share. Sovereign swaps and sovereign default: Fundamental versus confidence risk.

Inflation, Default Risk and Nominal Debt. Optimal Bailouts in Banking and Sovereign Crises. The Persistence of Entry. Female Entrepreneurship in the U. Microevidence from a system-wide financial meltdown: The German Crisis of Trade Policy is Real News. Poor Substitutes? Sticky Capital Controls. A Q-Theory of Inequality.

Measuring and decomposing output growth via PPI micro data. The Analytic Theory of a Monetary Shock. Asset pricing and decarbonization: diversification versus climate action. Curbing climate change in an unequal world. Time-Inconsistent Optimal Quantity of Debt. Credibility Dynamics and Disinflation Plans. By George-Marios Angeletos; M. Entrepreneurship through Spinouts, Innovation, and Growth.

Growth and the Fragmentation of Production. The Macroeconomics of Intensive Agriculture. Achieving Scale Collectively. Job Applications and Labor Market Flows. Vacancies, employment outcomes and firm growth: evidence from Denmark. Control costs, rational inattention, and retail price dynamics.

Entry Costs and the Macroeconomy. Efficient Redistribution. Redistributive Capital Taxation Revisited. TaxWedges, Financial Frictions and Misallocation. Border Effects, Governments, and Aggregate Productivity. Short-time work and precautionary savings. Job Search and Experimentation with Incomplete Markets. Disagreement about Monetary Policy.

Economic agents as imperfect problem solvers. Robustness and Dynamic Sentiment. The Global Financial Resource Curse. Tax Evasion and Wealth Taxation. Business Cycle Dynamics of the Wealth Distribution. Firm Productivity, Labor Quality, and Sorting. An application of machine learning to identify nascent high-growth firms. Darwinian Returns to Scale. Leveraged housing and job dynamics during the Great Recession.

Multinationals, Mark-Ups, and Markets. Product Innovation and Credit Market Disruptions. Agency in Intangibles. Robust q Theory. Founding Teams and Startup Performance. Daniel Kim; University of Pennsylvania. Robots or Workers? The demographic transition and the asset supply channel.

Structural Change, Inequality, and Capital Flows. Trade Wars, Currency Wars. Exchange Rate Disconnect Redux. The Unprecedented Fall in U. Revolving Credit. Why do homeowners invest the bulk of their wealth in their home? The Geography of Unemployment. Local Labor Markets and Aggregate Productivity. Constrained-Efficient Capital Reallocation. Private Overborrowing under Sovereign Risk.

Self-fulfilling debt crisis and limits to arbitrage. Risk Sharing, Complementarities, and Matching. Persistent Private Information Revisited. How do stock market experiences shape wealth inequality? A Quantitative Theory of Relationship Lending. Optimal Population on a Finite Planet. Zoning and the Density of Urban Development. Changing income risk across the US skill distribution: Evidence from a generalized Kalman filter. Job stability, earnings dynamics, and life-cycle savings. Mechanizing Agriculture: Impacts for Labor and Productivity.

Macroeconomic effects of household leverage regulations after the crisis. Globalization, Structural Change and International Comovement. Deindustrialization and Industry Polarization. Population aging and structural transformation. Coexistence of Money and Interest-Bearing Bonds.

Selecting the Aggregate Labor Supply Elasticity. Labor Market and Marriage Market Sorting. Local Interactions in a Market with Heterogeneous Expectations. Information Acquisition and the Pre-Announcement Drift. Spoofing in Equilibrium.

Competition, Stability, and Efficiency in the Banking Industry. Capital Mis allocation and Incentive Misalignment. Optimally Controlling an Epidemic. What is the impact of a major unconventional monetary policy intervention?

Taxing Our Wealth. Taxation and Private Insurance: the Importance of Transition. Trade Adjustment: Establishment-Level Evidence. Robot Imports and Firm-Level Outcomes. The original sin redux: a model based evaluation. Bargaining over Mandatory Spending and Entitlements. How to Save the American Dream: neighborhood based policies. Mergers and Acquisitions in Production Networks. Industry Linkages from Joint Production. Worker Mobility and Domestic Production Networks.

Recruitment policies, job-filling rates and matching efficiency. Recruiting Talent during a Recession. Inefficient Regulation: Mortgages versus Total Credit. The Supply and Demand for Safe Assets. Self-Insurance in Turbulent Labour Markets. Labor Market Policies, Regulation, and Informality. Entrepot: Hubs, Scale, and Trade Costs. Kerem Cosar; University of Virginia. Optimal Stress Tests and Liquidation Cost. Fiscal Rules and Discretion with Risk of Default. Sovereign Debt Sustainability and Redistribution.

Sudden Stops, Productivity, and the Exchange Rate. Unequal expenditure switching: evidence from Switzerland. Earnings Inequality in Production Networks. Firm behavior during an epidemic. Unemployment Insurance during a Pandemic. The Central Bank Strikes Back! Credibility of Monetary Policy under Fiscal Influence. Optimal Fiscal Policy without Commitment.

The Sectoral Origins of the Spending Multiplier. The Technology Multiplier for Employment. Blockchains, Collateral and Financial Contracts. Getting Blockchain Incentives Right. Cryptocurrencies, Currency Competition, and the Impossible Trinity. Measuring Automation in Aggregate Data. Technological Change and Occupations over the Long Run.

Inefficient Automation. Is there a Stable Relationship between Unemployment and future Inflation? Evidence from USA cities. Distribution of Market Power and Monetary Policy. Export Dynamics under Complementarities between Countries. Social Progressivity and Growth. Revisiting Unemployment with an Intensive Margin. Spatial Mismatch. Bank-Runs, Contagion and Credit Easing. Incentives for Early Retirement and Pension Reform. The Investment Consequences of Trading Frictions.

Inventory, market making, and liquidity. Risky Asset Liquidity. Market Power and Innovation in the Intangible Economy. Intangibles, Concentration, and the Labor Share. Selection and Absolute Advantage in Farming and Entrepreneurship. Human capital and financial development: Firm-level interactions and macroeconomic implications.

Sovereign Cocos. Redistribution with Performance Pay. Wedge Dynamics with Evolving Private Information. The Transmission of Monetary Policy under the Microscope. Idea Diffusion and Property Rights. Parallel Digital Currencies and Sticky Prices. Bayesian analysis of structural correlated unobserved components and identification via heteroskedasticity. The Transmission of Keynesian Supply Shocks. Uncertainty as a Predictor of Economic Activity. Multimodality in Macro-Financial Dynamics.

The Distribution of Labor Market Surplus. Technological Change and the Consequences of Job Loss. Carter Braxton , University of Minnesota. Diffusion on a Sorted Network. Growing large or growing old? A new perspective on the firm life cycle. Value Without Employment. Liquid equilibrium.

Q-Monetary Transmission. Bond Premium Cyclicality and Liquidity Traps. Gender Gap. Incarceration, Earnings, and Race. Child care markets, parental labor supply, and child development. Spatial Misallocation of Native Labor and Immigration. A Quantitative Analysis of Tariffs across U. Wage Setting Under Targeted Search.

Risky Business Cycles. Delayed Crises and Slow Recoveries. Why Does Oil Matter? Commuting and Aggregate Fluctuations. Banks, Maturity Transformation, and Monetary Policy. Financial Intermediaries and The Yield curve. Manufacturing and Construction Establishments. Relationship Skills in the Labor and Marriage Markets.

Gender Targeting in U. Newspaper Ads: Building Credit Histories. Mortgage Leverage and House Prices. Migration and Urban Economic Dynamics. Unpacking Moving. Homeownership and Labor Market Polarization. Patent-Based News Shocks. Cities and Technology Cycles. Loan market power and monetary policy passthrough under low interest rates.

Credit Supply, Firms, and Earnings Inequality. The Stable Transformation Path. Asset Pricing with Misspecified Models. Consumption and Hours between the U. Interbank Trade: why it's good and how to get it. Results: Median age at transplant was 8 years range, and median follow-up was 5. Median interval between diagnosis and HCT was 2. Ten 7. Increasing age was associated with lower OS HR: 1.

Donor type had no impact on cGvHD. Conclusions: Younger age was associated with better survival. Background: Diamond-Blackfan anemia DBA is an inherited bone marrow failure syndrome characterized by red cell aplasia and congenital anomalies. Patients with transfusion-dependent DBA who are unresponsive to corticosteroids can undergo allogeneic hematopoietic stem cell transplantation HSCT as a curative therapy.

However, there are limited data for determining the optimal conditioning regimen for patients with DBA. To evaluate the clinical course of DBA, we sent questionnaires to the physicians of the DBA patients enrolled in our cohort between and Results: Our DBA cohort consists of patients.

We performed genetic analysis in all patients, of whom Completed questionnaires were returned from the physicians of of the patients The median age of these patients at the time of diagnosis was 0. The median follow-up duration after diagnosis was 7. HSCT was performed in 27 patients The median age at the time of HSCT was 3. The median follow-up time after HSCT was 3. Transplantation sources were bone marrow in 25 patients from HLA-matched sibling donors in 5, HLA-mismatched related donors in 2, HLA-matched unrelated donors in 13, and HLA-mismatched unrelated donors in 5 and cord blood in 2 patients from HLA-mismatched unrelated donors.

MAC regimens were used in 13 patients, and RIC regimens with and without busulfan in 2 and 12 patients, respectively. Engraftment was successful in all 27 patients who underwent HSCT. One patient achieved neutrophil recovery and transfusion independency despite secondary graft failure. Optimal intensity of Conditioning Regimen CR in terms of both toxicity and efficacy is still to be clarified.

Overall TRM was low 1. Patients were selected for having received either BEAM or CYC and the availability of major neurological variables at both baseline and follow-up. Results: Number of CYC procedures was higher vs , respectively. Conclusions: The non-myeloablative regimen CYC-ATG has become the most common conditioning regimen despite a lack of comparative data with more intense regimens. In our retrospective analysis of the two most frequent conditioning regimens in the EBMT Registry, there was no significant difference in terms of prevention of relapses, whilst the CYC regimen showed a slight advantage over BEAM in Progressive patients in terms of disability progression.

The overall low incidence of relapses and the retrospective character of this analysis prevent to draw conclusions in terms of capability of the two conditioning regimens to restore the self-tolerance in MS. A prospective comparative trial is likely needed in order to provide a reliable information for this still unanswered question. Background: Resetting the immune system through autologous hematopoietic stem cell transplant autoHSCT is a highly effective treatment in selected patients with autoimmune diseases.

Likewise, use of autoHSCT in scleroderma patients has achieved superior outcomes in two randomized studies compared to standard of care Tyndall , Sullivan These impressive results are achieved by a combination of the eradication of autoreactive immune effector cells and re-establishment of self-tolerance, i. However, only a small fraction of eligible patients undergo autoHSCT, largely due to toxicity associated with current conditioning protocols.

Additional experiments are ongoing, and evaluation of this ADC in a murine model of diabetes will be presented. Targeted conditioning with CDADC may represent a better tolerated approach for removing disease-causing cells as part of immune reset through autoHSCT and may significantly reduce the morbidity and mortality associated with current conditioning. Methods: All French patients randomized , stratification according to centre in the multicenter open-label ASTIS trial from to , followed in parallel-groups until October 31, were subsequently included in the MATHEC cohort for extended follow-up with at least yearly evaluation with data collection up to last visit.

Delta values were calculated between 5 years and baseline. All analyses have been done by intention to treat. JAMA ; 24 New England Journal of Medicine ; 1 Background: At present high-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation AHSCT has been used with increasing frequency as a therapeutic option for MS patients. For comparison of survival log-rank criterion was applied. Median of MS duration - 5 yrs 0. Median follow-up after HSCT - The mobilization and transplantation procedures were well tolerated.

Transplant-related mortality - 2 pts 0. Average time until disease progression - Their severity significantly decreased after transplantation for the majority of scales. The vast majority of pts responded to treatment and exhibited clinical improvement or were stable during the follow-up. Background: Experimental allergic encephalomyelitis EAE is the animal model of multiple sclerosis MS , the autoimmunological human disease leading to neurodegeneration.

The autologous hematopoietic stem cell transplantation AHSCT has recently become the standard treatment for highly-active relapsing remitting MS. Anti-thymocyte globulin ATG which is a typical part of conditioning is thought to eliminate the autoreactive cells, which may persist after the chemotherapy. The other strategies of post-transplantation treatment are neither well developed in animal model nor in clinical transplantation.

Spinal cords were collected for further analysis. Disclosure: Nothing to declare. Supported by grant no. Bridging chemotherapy was permitted. J Clin Oncol. Interim efficacy endpoints were investigator-assessed using the revised International Working Group Response Criteria for Malignant Lymphoma Cheson, et al.

Updated results for all 60 patients will be reported in the presentation. Eight patients received bridging therapy; all had disease present post-bridging. There was 1 Grade 5 AE of organizing pneumonia, considered related to conditioning chemotherapy. Clinical Trial Registry: Clinicaltrials. DL2 was chosen for dose confirmation. Cytokine release syndrome CRS was graded per Lee criteria. ORR was assessed by independent review per Lugano criteria. No product could be manufactured for 2 patients, and 25 patients received nonconforming product.

In the optimized manufacturing process, median time from leukapheresis to liso-cel availability was 24 days. Twenty-five patients received liso-cel as outpatients. Outcomes were similar across DLs, so data were pooled. Four grade 5 liso-cel-related TEAEs occurred diffuse alveolar damage, pulmonary hemorrhage, multiple organ dysfunction syndrome, and cardiomyopathy. Safety was similar among patient subgroups.

All primary and secondary efficacy endpoints were met. Responses were similar across patient subgroups Table. Median PFS was 6. Median OS was Therapeutics, speakers bureau and consulting from Seattle Genetics, Janssen and Gilead, research funding, speakers bureau, consulting from Pharmacyclics, speakers bureau from Abbvie, research funding from Genentech, research bureau from Forty Seven Inc. However, another half of patients relapses from a short duration of response or refractory to CAR-T therapy.

The post-infusion responses, toxicities, and cytokine profiling in enrolled patients were observed and monitored. Cytokine arrays contains 45 different kinds of cytokines related to function of immune cell. Results: Baseline characteristics are listed in Table 1. With the median follow-up of days, 1-year overall survival OS and 1-year progression free survival PFS were estimated at Grade 1, 2, and 3 cytokine release syndrome occurred in 4 The main aim was to capture the rapidly growing activity in this field and the impact of the first commercial drug products targeting CD We were also interested to identify those academic clinical trials promoted by European institutions and currently open for recruitment.

Using monkey-survey, the survey was sent to EBMT-centers. We crosschecked the collected information with data available on the ClinTrialsGov and Eudract websites. Results: The updated survey is based on May report.

The number of European centers administering CAR T-cells has nearly doubled in 6 months from 34 to Only one additional country from 13 to 14 has started to treat patients with CAR T-cells during this period. There are now many more adult than pediatric patients Whereas in November , only 9 patients had been treated with marketed CAR T-cells, this figure rose to 90 in May We have identified at least 42 clinical trials with active recruitment in Europe. Of these, 27 are pharma-sponsored clinical trials, while 15 are academic clinical trials.

Of note, four European institutions fully prepare their own CAR T-cells, manufacturing both the genetic and the cellular product. Adult patients with NHL now represent the most frequent indication for treatment, because of commercial availability of approved products in this indication. The use of marketed CAR T-cells has increased by fold within 6 months, but still represents a minority of the ongoing activity.

This will be crucial to monitor potential improvements in the procedure over time, similar to the achievements made by EBMT in monitoring patients after hematopoietic stem cell transplantation for more than two decades. Inventor on gdT patents. Research support Miltenyi Biotech and Novartis. CAR products have been manufactured for 14 patients, 1 manufacturing is in process.

No neurological side-effects occurred, even not in patients with central nervous system CNS involvement. CART frequency reached up to CART production was feasible for all enrolled patients so far. Patients responded clinically to treatment despite low numbers of administered CARTs.

CARTs displayed a highly favorable safety profile, migrated into different compartments and were partly detectable for more than 3 months following administration. Sellner: Takeda: Employment. Background: CAR T cell therapy has generally been limited to inpatient treatment. Infusion and management of CAR T cell therapy in the outpatient setting may lead to wider use in nonuniversity centers and improved access.

Results are shown in the Table. Three patients received tocilizumab and corticosteroids for CRS none received tocilizumab alone; 2 received corticosteroids only. Five patients received corticosteroids for NEs. Clinical Trial Registry: ClinicalTrials. Carlos Bachier reports speakers bureau from Sanofi, and consultancy from Viracyte; M. Lia Palomba reports speakers bureau from Hemedicus immediate family member , consultancy from Merck immediate family member and Noble Insights, equity ownership of Seres Therapeutics immediate family member and Evelo immediate family member , membership on a Board of Directors or advisory committee from Seres Therapeutics immediate family member , STRAXIMM immediate family member , Kite Pharmaceuticals immediate family member , and Pharmacyclics, patents and royalties from MSK immediate family member ; Jeremy S.

Results: As of December 11, , patients were infused with tisagenlecleucel and evaluable for efficacy. Baseline tumor volume TV did not correlate with month 3 response. Median lactate dehydrogenase LDH levels at pre-infusion were higher in nonresponders NRs compared with patients achieving response.

Pre-infusion C-reactive protein CRP levels did not associate with month 3 response. Notably, higher median baseline TV, highest levels of serum biomarkers, highest LDH, and lowest platelet counts within 1 month post-infusion were observed in patients with severe CRS who were also NRs, compared with patients with severe CRS who achieved response and patients with grade CRS. The highest serum biomarker profiles post-infusion appeared to associate with patients with severe CRS who were also NRs.

Borchmann: Novartis: Honoraria, Research Funding. Holte: Novartis: Honoraria, Other: Advisory board. Teshima: Novartis: Honoraria, Research Funding. Han: Novartis: Employment. Tiwari: Novartis: Employment. Agoulnik: Novartis: Employment. Eldjerou: Novartis Pharmaceuticals Corporation: Employment. Bubuteishvili Pacaud: Novartis: Employment. Therapy-associated toxicities including cytokine release syndrome CRS and neurotoxicity are well tolerable. Current clinical trials focused on clinical data about efficacy and toxicities.

No detailed studies of corresponding mechanisms have been reported currently. Results: As of the data cut-off date December 10 th , , 39 patients, median age The median observation period is 8. ORR was Partial response 6 PR, Durable responses from 4 weeks towards the data cut-off date median follow-up time 8.

CRS was reported in all the 39 patients, including 6 with Grade 1, 15 with Grade 2 and 18 with Grade 3. During follow-up, 1-year progression-free survival PFS was These initial data provide strong evidence to support the further development of this anti-myeloma cellular immunotherapy. Background: Calcium signals play irrefutable role in the regulation of cell activation, differentiation and effector functions, no exception of T cells.

Till now, the answers to the two questions still remain unclear for us: whether the activation of CAR-T cells is accompanied by changes of calcium ions and how do the calcium ions affect the phenotype or effector function of CAR-T cells? While the expression of CD25 and CD69 did not show significant differences. Conclusions: The intracellular calcium ion affects the differentiation and antitumor efficacy of CART cells. JAMA Oncol.

Results: The procedure was generally well tolerated. Only seven infusions required corticosteroids. Overall survival was 16 months for patients that achieved CR after MST, and 1 month for non-responders. MST provides remarkably high rates of CR, can be successfully used a second time in patients who relapse, and as a bridge to allogeneic transplantation in selected cases. While numbers of haplo-SCT are growing rapidly worldwide, taking advantage of rapid availability of potential donors, there remains a need to fully evaluate the safety profile and efficacy of DLI in the setting of unmanipulated haplo-SCT.

Few single center studies analyzed the experience of DLI after haplo-SCT and there is a great variability in clinical practice among centers. Furthermore, there is no available prospective clinical trial that may elucidate the uncertainties around its clinical application.

Methods: We here report efficacy and safety data for patients median age Results: Median follow-up was The median interval between withdrawal of immunosuppression and DLI was 2. While the rate of a-GVHD appears acceptable, survival rates remain relatively low in this small group of patients, with relapses contributing to most deaths. A thorough evaluation of this approach will only be possible in prospective trials using harmonized procedures for cell doses and sequence of infusions.

Background: Severe viral infections remain a major source of non-relapse mortality and morbidity in recipients of ab T cell-depleted grafts. As we have shown, infusions of low doses memory T-cells are safe and potentially effective.

Here we report the results of a retrospective analysis of an extended cohort with the emphasis on T cell repertoire probing. Indications for HSCT included hematologic malignancies in 80 cases and non-malignant diseases in 51 cases. CD45RA-depleted fraction was cryopreserved for further use. Results: Overall patients received memory DLI after engraftment of primary graft. At the last follow-up patients were alive and free from primary disease. On day DLI-derived T cell clones comprise on average Conclusions: Our data suggest that depletion of ab T cell from the primary graft and with low-dose memory DLI, which are able to transfer pathogen-specific immunity to common infections, can be safely combined to improve the overall results of HSCT from haploidentical and matched donors.

Background: Relapse is the leading cause of treatment failure after allogeneic hematopoietic stem cell transplantation allo-HSCT for acute leukemia with high-risk features. Donor lymphocyte infusion DLI has been proved to exhibit a strong graft-versus-leukemia GVL effect in patients with hematologic relapse after transplantation. Methods: The high-risk features of acute leukemia were defined by the following criteria: i primary chemoresistance; ii advanced disease at transplantation beyond the second complete remission or active diasease ; iii relapse after allogeneic transplantation; iv MRD positive at transplantation; v unfavorable genetic abnormalities, such as t 4;11 , IKZF-1 and TP53; vi t 9; 22 or FLT3-ITD mutation without prophylactic target therapy after transplantation.

For each prophylactic DLI recipient, a control who were matched for diagnosis, primary chemoresistance or not, genetic risk stratification, donor type, disease and MRD status at transplantation, was randomly selected from patients without prophylactic DLI. Altogether forty-four well-matched pairs were identified to analysis the safety and efficacy of prophylactic DLI.

Results: The 3-year overall survival OS Prophylactic DLI recipients achieved significantly lower 3-year cumulative incidence of relapse Higher 3-year cumulative incidence of chronic GVHD Conclusions: These data indicated that prophylactic DLI after allo-HSCT effectively decreased the risk of relapse and improved survival of patients with high-risk acute leukemia without increasing the risk of acute GVHD or treatment toxicity.

However, little is known about the mechanism by which adoptively transferred CTLs exert durable responses. Therefore, we studied the relationship between response and recipient factors. The median time from HCT to treatment was days range Conclusions: We demonstrate that adoptive therapy with CMV CTLs may rely on recipient immune components to mediate durable response to therapy.

We report the results the results of 83 haploidentical DLI infused in 30 patients from 4 transplant centers, following unmanipulated HSCT. Median age at transplant was 37 years-old. DLI were collected from the original donor, without priming agents before the apheresis. Conclusions: Haploidentical DLI induced long term maintained responses when used prophylactically or preemptively.

Our study also highlights the difficult to treat patients with overt relapse, who showed very poor results with these approach even in combination with chemo or radiotherapy. NK cells have anti-leukemic activity but are deficient in number and function in AML patients and are ablated by high-dose chemotherapy.

NK cells were expanded on feeder cells and cryopreserved for infusion at the assigned dose level, then thawed and infused thrice weekly for six doses after fludarabine, cytarabine, and G-CSF FLAG. Response was assessed at day Results: NK cell production was feasible for all subjects. Patients had a median of five prior therapies, including nine with prior stem cell transplantation.

Therapy was tolerated with manageable toxicity in such an ill population of patients. Median neutrophil and platelet recovery were at day 33 and 44, respectively. Conclusions: Repeated infusions of high doses of cryopreserved expanded NK cells are feasible and well-tolerated after high-dose chemotherapy and demonstrate encouraging systemic and CNS responses in high-risk AML.

A multi-variable Cox model was used to test transplantation as a time-dependent variable. The cumulative incidences of transformation into AML at 1 year were 7. At the time of diagnosis the expected life time of higher risk patients was When we performed a simulation in year old patients, transplantation in untransformed lower risk patients was detrimental.

Of note, older patients kept the advantage of survival with transplantation if they were at higher risk. Conclusions: For the first time, we could analyze the impact of transplantation over time on survival in CMML. In lower risk patients who remain untransformed within 24 months, survival with or without transplantation was similar, except for older patients where survival was decreased with transplantation.

In higher risk patients, transplantation improved survival. Patnaik: Stem Line Pharmaceuticals. European Medicines Agency EMA approval of ibrutinib and idelalisib in mid followed by venetoclax end have deeply modified this therapeutic paradigm. At transplantation, the median age was 57 years. Donors were HLA-identical sibling, unrelated or mismatched relatives in The median follow-up of living patients post-transplant is Overall the number of alloHCT decreased from a mean of for the period , to in and 94 in Within these 8 countries, there was a dramatic reduction in the number of alloHCT from a mean of per year for the period to in and 75 in Fig 2.

The number of alloHCT as a proportion of the population of each country decreased from 1. There was some variation, the reduction being more gradual and from a smaller baseline in Italy, France and the United Kingdom. This decrease that began between and clearly followed the availability of ibrutinib and idelalisib. Background: A large multicenter retrospective study has been conducted to evaluate the main determinants of survival in transplanted patients with myelofibrosis MF and to describe the predictive factors for the main complications after allogeneic hematopoietic cell transplantation allo-HCT.

Period of first allo-HCT, patients and donor characteristics, disease risk profile, transplantation modalities, and the main post-transplant complications were taken into account for the analysis of factors predicting survival. Time-dependent variables were considered only after the first transplant and were analyzed by the time-span splitting method.

Results: After a median follow-up of 4. Projected median survival was 5. Graft failure increased in recipients of unrelated donors and decreased with myeloablative conditioning MAC and negative cytomegalovirus serostatus of both donor and recipient. Acute and chronic GVHD reduced the subsequent risk of relapse.

Conclusions: We have characterized the prognostic significance of the main landmark events occurring after allo-HCT in MF patients and the predictive factors for these events. This information has potential implications for patient counseling and clinical decision-making. Unadjusted survival by risk factor after transplant in patients with myelofibrosis]. Background: Pretransplant splenectomy may improve allogeneic hematopoietic cell transplant allo-HCT outcomes but is associated with substantial morbidity and mortality that may delay or cancel a project of transplant.

This study aims at determining whether pre-transplant splenectomy precludes subsequent allo-HCT, in myelofibrosis MF patients waiting for a transplant. With the Promise database, we identified transplanted patients, along with data regarding pretransplant splenectomy. For non-transplanted patients, local centers provided data from medical files.

We excluded patients splenectomized before the initiation of unrelated donor search ie, at registration. Similarly, patients could move from state 2 to state 3 or 4. We used Cox models with splenectomy as a time-varying variable and a clock-reset timescale to evaluate the association between splenectomy and subsequent HSCT or death.

Results: We recruited and analyzed patients from 57 centers in France. Median age was 59 years old interquartile range [IQR], 53 to 63 years old and Median follow-up was 6 years. Eighty-one patients were splenectomized after registration, of whom 65 underwent subsequent allo-HCT and 9 died. Stacked probabilities of being in each state as a function of time are represented with the Aalen-Johansen estimator Figure 1.

At each timepoint, the distance between 2 adjacent curves represent the probability of being in the corresponding state. For instance; two years after registration on the RFGM, the estimated probabilities were: Splenectomized patients had a higher probability of being transplanted in the first 4 months after splenectomy, in comparison with non-splenectomized patients unadjusted HR [Hazard Ratio], 7. However, its impact on post-transplant outcomes must be clarified before recommending larger indications for it.

Background: Empiric weight-based anti-thymocyte globulin ATG dosing in heavier patients prior to ex vivo CDselected allogeneic hematopoietic cell transplantation allo-HCT is associated with high non-relapse mortality NRM and poor survival Scordo et al. We hypothesized that poorer outcomes observed with ATG overexposure derive from impaired immune reconstitution IR. Methods: We studied consecutive adult patients who underwent first myeloablative ex vivo CDselected allo-HCT with ATG Thymoglobulin for antirejection prophylaxis between and Results: Among all patients, median follow-up was 3.

All but 2 patients, who were inevaluable on account of early deaths, engrafted. All patients received doses of ATG 2. As improvements in supportive care contribute to decreasing NRM rates after MAC, a reassessment of these two strategies is warranted. Cox proportional hazards regression models cause-specific for competing risk data were constructed for all outcome measures.

Results: A total of patients were included. Median age was 39 range years. There were no significant differences in the distributions of Karnofsky performance status, cytogenetic risk, secondary AML or disease status at transplantation.

Median follow-up was Additionally, adverse cytogenetics and second relapse status were associated with an increase in RI and lower OS in the multivariate model. Background: The use of hematopoietic cell transplantation from haploidentical donors haplo-HCT for adults with acute lymphoblastic leukemia ALL is increasing.

While immunosuppression based on post-transplant administration of cyclophosphamide PT-Cy is preferable in this setting, the choice of optimal myeloblative conditioning remains unclear. The incidences of both acute and chronic GVDH were also comparable. However, as the profile of treatment failures differ, the choice of conditioning should be personalized. Prospective, randomized studies are warranted to verify our findings.

Background: Busulfan and cyclophosphamide BuCy is a frequently used myeloablative conditioning regimen for allogeneic hematopoietic cell transplantation allo-HCT. Theoretical considerations and pharmacological data indicate that prior application of busulfan may trigger liver toxicity of subsequent cyclophosphamide. Reversing the order of application to cyclophosphamide-busulfan CyBu might be preferable, hypothesis supported by animal data and retrospective studies. The aim of this randomized clinical trial is to test the impact of the order of application of Bu and Cy before allo-HCT.

Methods: We performed a prospective multicenter Basel, Geneva, Zurich open label randomized study exploring the order of drug application BuCy versus CyBu. The primary endpoint was liver toxicity at day 30 after HCT.

Additional endpoints were liver toxicity at day , incidence of veno-occlusive disease VOD , relapse and overall survival at day Survival analysis was by Kaplan-Meier estimator using the log-rank test and TRM and relapse by cumulative incidence function using Fine and Gray to test for differences. CyBu group. Conclusions: This prospective RCT examined the order of busulfan and cyclophosphamide administration as part of myeloablative conditioning in allo-HCT patients and found some evidence of superiority of CyBu over BuCy.

We show lower liver toxicity at day 30, lower TRM and a tendency of better longterm overall survival in patients receiving CyBu instead of BuCy. However, the level of rATG persisting in the post-HCT period is variable and its main toxicity is poor immune reconstitution. No restrictions were applied in terms of donor source, indication, conditioning, and age. Cox proportional hazard models, and multi-state competing risk models were used for analyses. Median age at transplant was 11 0.

Kevin J. Nancy A. Kernan, MD: Nancy A. Kernan, MD: Conflicts. Median age was 47 years Finally, in our study a lower rate of grade oral mucositis was reported in the TEAM group, whereas infectious complications, other non-hematologic toxicities and TRM were similar among the three groups of patients. Conclusions: Despite the limitations due to the non-randomized nature of this study, in our experience TEAM regimen seems to be associated to a worse clinical outcome in terms of PFS but not OS both in overall patient population and in patients with pre-transplant uncontrolled disease.

Further studies are warrant to confirm these results. Background: Allogeneic hematopoietic cell transplantation HCT is potentially curative in patients with high-risk acute lymphoblastic leukemia ALL. However, the role of conditioning intensity to transplant outcomes remains unclear.

All patients received HCT between and Overall survival OS was calculated using Kaplan-Meier analysis and Cox proportional hazards regression. Background: Refractory prolonged isolated thrombocytopenia RPIT is an intractable complication after allogeneic hematopoietic cell transplantation HCT which often leads to a poor prognosis.

Existing treatment options result in limited response, and new approach for this setting is demanded. We have conducted a randomized trial to validate the efficacy and safety of low-dose decitabine in HCT-RPIT patients, and we have further explored the underlying mechanisms. Methods: This prospective, open-label, three-arm clinical trial was conducted in 6 transplant centers between October to April The primary endpoint was an increased platelet count.

Secondary endpoints included megakaryocyte counts 4 weeks after treatment and the survival during an additional follow-up of 24 weeks. The protocol was approved by the institutional review board at each participating center. All the participants provided written informed consent. The study was registered at ClinicalTrials. Results: A total of 97 patients meeting the inclusion criteria were enrolled into this study. Among the evaluable 91 patients, the response rates were With a median follow-up of 11 months, the estimated 1-year survival of either Arm A Endothelial cells as well as cytokines relating to migration and endothelial cell damage were improved in patients responding to decitabine.

Conclusions: Decitabine effectively facilitated platelet recovery in HCT-RPIT patients, presumably by promoting the repair and reconstitution of megakaryocytes and marrow endothelial cells. In this context, failure to respond to steroid therapy is associated with an absence of further therapeutic options, and is an unmet medical need. These patients had previously received and failed 1 to 5 lines median 2 of GvHD systemic treatments. GvHD response was evaluated 7 days after each administration and 28 days after the first dose.

Batch release specifications are based on potency viability , identity diversity , and purity microbiological safety testing and proportion of proinflammatory species , ensuring the desired consistency between batches. Among the 11 treated patients, 7 were still alive at last follow-up median days; [range, ] Among the 5 patients with CR, all were still alive at last follow-up and were able to taper or stop steroids and immunosuppressants.

Only one patient presented GI symptoms recurrence at 3 months. Of note, molecular relapse of hematologic malignancy was observed in another. The safety of the MaaT microbiota biotherapeutic was satisfactory in all patients. One patient developed a possibly related sepsis one day after the third dosing. In this case, no pathogen was identified in blood cultures, and the patient recovered after a course of antibiotics.

Conclusions: We report for the first time the treatment of 11 patients with steroid-dependent or steroid-refractory intestinal aGvHD using a full ecosystem, standardized, pooled-donor, high-richness biotherapeutic.

With up to 5-year follow-up, integration was polyclonal and no oncogenesis was recorded. Statistics are presented as median min-max. Results: As of 12 June and 30 September , 34 patients were treated in Northstar-2 and Northstar-3 with a follow-up of Treatment characteristics are shown in Table 1. All patients are alive and all samples showed a polyclonal vector integration profile.

Weighted average Hb during TI was HbA T87Q levels were 8. Myeloid:erythroid ratios in patients who achieved TI were at At Months 6 and 12, total unsupported Hb was Two evaluable patients achieved transfusion independence. The safety profile is consistent with single-agent busulfan myeloablation. Janet Kwiatkowski: Consultancy for bluebird bio, Inc.

Alexis Thompson: Consultancy for bluebird bio, Inc. Andreas Kulozik: Consultancy and Honoraria for bluebird bio, Inc. Isabelle Thuret: Investigator for bluebird bio, Inc. Ashutosh Lal: Research Funding for bluebird bio, Inc. Background: Metachromatic leukodystrophy MLD , a fatal demyelinating lysosomal storage disease resulting from arylsulfatase A ARSA deficiency, currently has no effective treatment.

Following busulfan conditioning, the drug product was infused intravenously. Key endpoints included reconstitution of ARSA activity, safety and tolerability of OTL, and effects on gross motor function and cognitive development, compared to a natural history NH cohort. Results: Of 33 patients treated, 30 are alive 2 died from disease progression, 1 from cerebral stroke. There was no treatment-related mortality, no malignancies, no abnormal clonal expansion, and no evidence of replication-competent lentiviruses.

All patients achieved hematological recovery and showed stable engraftment of gene-corrected cells. Restoration of ARSA activity was observed in the hematopoietic system and cerebrospinal fluid. Preliminary data from patients treated with the cryopreserved formulation show engraftment and ARSA activity comparable to those from patients treated with the fresh formulation. The majority of pre-symptomatic patients displayed long-term stabilization of motor function, many within normal range.

Luigi, Naldini also reports holding a patent for a product referred to in the presentation or marketed by OTL or in receipt of royalties. Humanized NSG mice treated with a single dose had full depletion of human HSPCs in the bone marrow, while maintaining peripheral immune cells. There was no effect of the ADC on the peripheral and bone marrow lymphocytes and the ADC was well tolerated compared to busulfan where multiple severe adverse events were seen.

The primates engrafted neutrophils day 8 and 10 and platelets day 10 and 11 , while peripheral lymphocytes were maintained throughout the transplant. Longer follow up and data from additional animals will be presented. This targeted approach for safer conditioning could improve the risk benefit profile for patients undergoing HSCT and enable more patients to benefit from these potentially curative therapies.

Background: Cerebral adrenoleukodystrophy CALD is a rare metabolic disorder in which rapid and progressive inflammatory cerebral demyelination leads to irreversible loss of neurologic function and death. Early diagnosis and treatment are key to ensure optimal long-term outcomes. The primary efficacy endpoint of this study is the proportion of patients who are alive and free of major functional disabilities MFD at Month Additional assessments include engraftment failure, and changes in neurologic function score and Loes score.

The median DP cell dose was Median day of neutrophil and platelet engraftment was Median follow-up time is Fifteen patients have completed 24 months of follow-up in ALD and continue to be free of MFDs through their last follow-up in a long-term extension study.

Fourteen patients remain in ALD, with the longest follow-up among these patients at Another patient experienced early and rapid disease progression while on study that resulted in multiple MFDs, and the patient subsequently died. All patients engrafted and there have been no reports of GVHD or transplant-related mortality. Recorded adverse events are generally consistent with myeloablative conditioning.

There is no evidence of replication competent lentivirus or insertional oncogenesis. Conclusions: Lenti-D DP appears to stabilize cerebral disease progression and shows favorable safety with the longest follow-up at Additional follow-up is ongoing to assess durability of treatment and long-term safety.

Florian Eichler has received consulting fees from Ionis Pharmaceuticals and SwanBio Therapeutics and financial support from bluebird bio and Minoryx Therapeutics to conduct clinical trials. Paul J. Orchard, Troy Lund, and Patrick Aubourg have received grant support from bluebird bio.

Nicholas Smith has received clinical trial funding from bluebird bio. David A. Williams has received research funding from bluebird bio and is an inventor on intellectual property licensed to bluebird bio. Background: Allogeneic hematopoietic stem cell HSC transplantation allo-HSCT is a treatment option for several monogenic inherited diseases; however, its use is limited by the need for a matched donor and risk of immunological complications.

Safety outcomes following autologous gene modified HSCT in these ongoing studies are summarized. Results: Across all 6 studies, patients have been treated as of last follow-up Table 1. No patient experienced primary or secondary graft rejection. One patient with CALD experienced disease progression and died 22 months after drug product DP infusion of disease complications.

All other patients remain alive. Myelodysplastic syndrome was reported in one patient with SCD; after investigation for LVV insertion in malignant cells, the AE was assessed as not related to LentiGlobin insertion or transgene expression. Additionally, there were no AEs related to vector integration. Paul Orchard: Received grants from bluebird bio, Inc. Christine Duncan: Consulting fees for bluebird bio, Inc. Patrick Aubourg: Received grants from bluebird bio, Inc.

Nicholas Smith: Clinical trial funding from bluebird bio, Inc. Weiliang Shi, Richard A. Mark Walters: Consultancy for Editas, Trucode. AllCells, Inc. David Williams: research funding from bluebird bio, Inc. Sauer, Suradej Hongeng, Markus Y. Background: Lentiviral vector-mediated haemopoietic stem cell HSC gene therapy is a potentially curative treatment that represents an alternative to allogeneic HSC transplantation for patients with WAS. Here, we report safety and efficacy data on the use of a self-inactivating vector LV-w1.

Results: The splenectomised adult patient died 4 years post-gene therapy from pneumococcal sepsis, having stopped prophylaxis. This report discusses outcome across paediatric patients. All patients were alive at a median follow-up of P4 had failed to engraft after a cord transplant and had failed to mobilise twice pre-gene therapy.

Patients with eczema demonstrated resolution at a median of None of the patients had viral reactivation at days post gene therapy. Late infections requiring hospital admission was recorded in 2 patients; P5 for influenza and P1 splenectomized developed pneumococcal pneumonia at 6 months and then 8 years post-gene therapy. Three patients developed autoimmunity at a median of One patient; P3 remains on a tapering dose of immunosuppression at last follow-up, for management of late onset nephrotic syndrome at Two patients were splenectomised; P1 post-gene therapy and P4 pre-gene therapy for thrombocytopenia.

None of the patients had bleeding episodes after gene therapy. Multilineage engraftment in peripheral blood of gene-corrected cells was sustained to the latest time point analysed and was associated with WAS protein WASp expression by flowcytometry as shown in figure 1. T cells exhibited the highest level of gene marking and WASp expression at 12 months post-gene therapy.

Four patients discontinued immunoglobulin replacement with adequate vaccine responses at a median of Integration site analysis was carried out for 3 of 6 patients and showed no evidence of sustained clonal dominance at sites linked to proto-oncogenes.

Conclusions: Data from this study demonstrates robust immune recovery with reduction in infections and eczema together with a sustainable but often modest increase in platelet count after gene therapy for WAS. Patients received myeloablative busulfan conditioning, were infused with LentiGlobin drug product DP and monitored for adverse events AEs , Hb fractions, and other parameters. Data are shown as median min-max. All but 1 patient had neutrophil and platelet engraftment as of the data cut date.

A decrease in hemolysis markers was also seen post-DP. Serious AEs occurred in 6 patients; the most frequent were nausea and vomiting. To date, there have been no cases of DP-related AEs, graft failure, vector-mediated replication competent lentivirus, or clonal dominance. Janet Kwiatkowski: Consultant for bluebird bio, Inc. Alexandra Miller, Francis Pierciey Jr.

Markus Y. Mapara, John F. Tisdale, Lakshmanan Krishnamurti have nothing to disclose. Background: cGVHD exhibits both autoimmune and fibrotic features across multiple organ systems. Treatment was until progression or toxicity. Results: 17, 16, and 21 pts were enrolled in C1, C2, and C3. As of 30Jun19, median duration of follow up was 30, 26 and 19 months mos respectively.

Median age was 52 yrs, median time from cGVHD diagnosis was 20 mos, and median prior lines of therapy was 2. The median duration of treatment was 9, 8, and 9 mos, respectively. Reasons for discontinuation included cGVHD progression 20 , voluntary withdrawal 7 , relapse of underlying disease 6 , investigator decision 5 , AE 3 , and death 2. CRs were observed in all affected organs except lung; PRs were observed in lung. Baseline median CS dose was 0.

No apparent increased risk of infection was observed. Conclusions: Durable and clinically meaningful responses have been seen across all 3 cohorts. KD was well tolerated, allowing pts to remain on treatment and realize benefits of sustained therapy. Background: IL has been shown to support intestinal mucosa after damage through multiple mechanisms, including direct signaling to the intestinal epithelium that promotes its survival and regeneration as well by inducing epithelial production of innate antimicrobial molecules such as REG3.

Additional endpoints included day 56 treatment response, evaluation of changes in gut microbiota by 16S sequencing, and plasma GVHD biomarkers. All pts had detectable F levels and measurement of CRP levels in a subset of patients confirmed in vivo biologic activity. Three pts had repeat GI biopsy after treatment and demonstrated improvement in GI epithelial injury Fig. These findings support further development of this approach and provide a proof-of-concept for combining standard immunosuppression with tissue-supportive strategies to enhance recovery of damaged mucosa, promote microbial health, and improve GVHD treatment response.

Furthermore, our findings suggest that monitoring of the intestinal microbiome could function as a biomarker of treatment response in GI aGVHD. Nothing to declare: Amin M. Alousi; Ryotaro Nakamura; Karamjeet S. Sandhu; Juliet N. Background: Acute graft versus host disease aGVHD remains the major cause of non-relapse mortality NRM following allogeneic hematopoietic cell transplantation. Treatment response on day 28 is the standard surrogate for long-term outcomes in clinical trials despite limited accuracy.

Results: Median age was 12y range 0. Change in MAP from d0 to d28 also predicted outcomes. Conclusions: We have validated the MAP as both a prognostic and a response biomarker in children with aGVHD and shown that it is a better predictor of long term outcomes than clinical severity. Research funding, Servier, Kite. PM: Honoraria, Amgen, Neovii. RN: Research funding, Helocyte, Miyarisan. Research funding: Miltenyi, Adaptive. Research funding, Kamada.

CK: Honoraria, Novartis, Mallinckrodt. Research funding, Incyte, Kamada. Background: Chronic GvHD affects more than half of the patients after allogeneic hematopoietic cell transplant allo-HCT , and a majority of them suffer from ocular GvHD that can lead to excruciating pain and permanent vision loss in severe cases. There is no FDA-approved treatment to date as the current options are limited and mostly ineffective.

While the precise mechanism of action is unclear, a cranial nerve V1 mediated neuro-pathway has been implicated. All subjects had moderate to severe eye symptoms, were free of other major ocular comorbidities, and remained on previous ocular treatments and systemic immune suppression through the trial. Subjects were randomized in a treatment to placebo fashion.

The trial drug or placebo was self-applied to the forehead in the home settings twice a day for a total of 10 weeks. All subjects kept daily diaries to document their medication use and symptoms, and were evaluated in the clinic at baseline, 2 weeks, 6 weeks and 10 weeks. The endpoints of the study were patient reported ocular symptoms and physician recorded ocular signs such as ocular surface staining and tear film.

Safety assessments included blood tests of hematology, chemistry and endocrine panels. Results: 32 out of the 33 enrolled patients completed the trial with 21 in the active arm and 11 in the placebo arm. Only 1 patient was lost to follow up.

Treatment was well tolerated and compliance was high. There was no severe adverse event in the active arm. Strikingly, the reduction of global score was significantly superior in the active arm at 6 weeks Patients specifically reported improvement in light sensitivity, airflow sensitivity, and eye pain among other parameters that improved their quality of life.

The systemic progesterone level in the active arm did not change significantly within the 10 weeks. All subjects in the placebo arm received crossover active treatment for 6 weeks. It appears to be a safe and effective novel treatment for chronic oGvHD. A larger randomized phase III trial to confirm the results is planned.

Background: Effect of single or multiple mismatches at each HLA locus on outcomes after cord blood transplantation CBT remains unclear. Median total nucleated and CD34 cell doses were 2. The median number of allele mismatches was 3 range, Other locus mismatches were not associated with this risk. There was no impact of HLA locus mismatches on overall survival. Not only locus mismatch but also the number of mismatches at the DRB1 locus may be considered in cord blood unit selection.

Background: KD is an orally available Rho-associated coiled-coil kinase 2 ROCK2 selective inhibitor that decreases pro-inflammatory Stat3 and increases Stat5 favoring regulatory T cells. Treatment was until clinically significant progression or unacceptable toxicity.

A pre-specified interim analysis IA occurred 2 months after the last pt was enrolled, with the primary analysis to occur 6 months after the last pt was enrolled. Results: At this IA, median range duration of follow up was 5 2, 12 months.

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