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Clinical Trial Summary

The present project aims at comparing two conditioning regimens (Fludarabine-Melphalan (FM) vs Fludarabine-Melphalan-ATG (FM-ATG)). The hypothesis is that the FM-ATG regimen will be associated to better cGRFS.


Clinical Trial Description

This study is a multicenter, randomized, open-label, phase III study, comparing 2 conditioning regimens. A total of 284 eligible patients with HLA (Human Leukocyte Antigen)-matched donors will be randomized 1/1 between the FM arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 5 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for Graft-versus-host disease (GVHD) status, disease status, second malignancy and QOL). The whole study will be completed within 20 years. The hypothesis is that the FM-ATG regimen will be associated to better cGRFS (current GVHD-free, relapse-free survival). ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoid Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Chronic Lymphoid Leukemia
  • Chronic Myeloid Leukemia in Remission
  • Hodgkin Disease
  • Hodgkin Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorder
  • Myeloproliferative Disorders
  • Myeloproliferative Syndrome
  • Non Hodgkin Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Syndrome

NCT number NCT03852407
Study type Interventional
Source University Hospital of Liege
Contact Frédéric Baron, MD,Ph
Phone +32 4 366 72 01
Email F.Baron@uliege.be
Status Recruiting
Phase Phase 3
Start date February 4, 2019
Completion date November 1, 2038

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