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Acute Leukaemia Working Party: Call for participation in five studies

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ALWP retrospective data collection : Haploidentical transplantation

Post-transplant Cyclophosphamide (PT-CY) for haploidentical transplants in adults with acute myeloid leukemia: a comparison of two different schedule: PT-CY day +3+4 or day +3+5.

PI: Patricia Chiusolo.

Primary objective: On behalf of the ALWP of  EBMT we want to analyze the impact of different use of PT-Cy (d+3 and 4 versus d+3 and 5) as part of GvHD prophylaxis on outcomes after unmanipulated non T-cell depleted Haplo  graft in adults with acute leukemia according to the currently available evidence derived from EBMT centers’ practice.

Patient Inclusion Criteria
  • Patient diagnosed with acute myeloid leukemia in all disease status at time of transplantation
  • Patient age ≥18 years at HSCT
  • Patient who underwent a first allograft between 2010 and 2016
  • Patients who received BM or  PBSC from related mismatched haploidentical donor (host-donor genotypical identity on shared haplotype AND host-donor number of mismatches ≥2 on unshared haplotype)
  • PT-CY included as part of GVHD prophylaxis
Patient Exclusion Criteria
  • Prior allogeneic HSCT (autologous HSCT could be included);
  • Ex-vivo T cell depletion

Non T depleted Haploidentical Stem Cell Transplantation: Exploring the hierarchy for choosing the optimal donor.

PI: Ivetta Danylesko.

Primary objective: Exploring the hierarchy for choosing the optimal donor

Eligibility Criteria
  • 1st Haploidentical Stem Cell Transplantation with Ptcy / or ATG                             
  • Non T depleted                              
  • Patient transplanted for AML and ALL                 
  • Adults patients               
  • Patients who underwent allograft between 2010 to 2016 (included)
Exclusion Criteria
  • Prior allogeneic HSCT (Autologous HSCT can be included)                                         
  • 2 donors/2 products?

Comparison of outcomes according to post-transplant cyclophosphamide doses after haploidentical stem cell transplantation in patients with acute myeloid leukemia in first complete remission

PI: Rémy Dulery & Louis Bouard

Primary objective: To compare at 12 months the efficacy of PT-Cy at 100 mg/kg versus lower doses of PT-Cy for GVHD prophylaxis in the setting of haploidentical stem cell transplantation in patients with acute myeloid leukemia in first complete remission, as determined by a composite endpoint of GVHD-free, relapse-free survival (GRFS)

Secondary endpoint:

  • To evaluate the occurrence of grade 2-4 and grade 3-4 severe acute GVHD within the first 6 months after transplantation.
  • To evaluate the occurrence of chronic GVHD within the first 12 months after transplantation.
  • To evaluate non-relapse mortality within the first 12 months after transplantation.
  • To evaluate disease-free and overall survival at 12 months after transplantation.
Inclusion Criteria:
  • Acute myeloid leukemia in first complete remission
  • Age ≥ 18 years.
  • T-cell-replete haploidentical stem cell transplantation using PT-Cy
  • Bone marrow or peripheral blood stem cell grafts
Exclusion Criteria:
  • Prior allogeneic stem cell transplantation
  • use of in-vivo TCD

If you are interested in these studies, please contact the Data office Paris at ebmt.do-paris@ebmt.org

 

ALWP retrospective study: Comparison of RIC-AlloHSCT vs. autoHSCT for ALL > 55 years old

PI: Sebastian Giebel

Primary objective: To compare allogeneic HCT with reduced intensity conditioning versus autologous

HCT for elderly patients with acute lymphoblastic leukemia

Secondary objective: To determine prognostic factors after RIC-alloHSCT and autoHSCT

Inclusion criteria:
  • ALL in CR1
  • Age > 55 years Old
  • RIC-alloHSCT or autoHSCT between 2000-2017
  • In case of RIC-alloHSCT: HLA-identical sibling or MUD
Exclusion criteria:
  • CBT

If you are interested in this study, please contact Mohamed Houhou mohamed.houhou@umpc.fr

ALWP retrospective study: Prevalence and outcome of central nervous system (CNS) relapse after allogeneic stem cell transplantation (HSCT) in patients suffering from acute myeloid leukaemia (AML) and acute lymphoblastic leukaemia (ALL)

PI:  Sabine Blum & Yves Chalandon

Primary objective: To define prevalence of CNS relapse in the post HSCT setting, to compare the prevalence between the different disease forms. To clarify if therapy before HSCT has an influence on CNS relapse rate. To define outcome in patients with CNS relapse. To describe treatment of CNS relapse post-alloHSCT and compare different treatments.

Eligibility Criteria (Patient Inclusion/Exclusion criteria):
  • Patients over the age of 18 years
  • who underwent an HSCT for AML or ALL between 1996 and 2016.
  • All conditioning regimens and all sources of stem cells are eligible.
  • Patients in CR

If you are interested in this study, please contact the Data office Paris at ebmt.do-paris@ebmt.org