NCT03852407 Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
| NCT ID | NCT03852407 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Liege |
| Condition | Acute Myeloid Leukemia in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2019-02-04 |
| Primary Completion | 2033-11-01 |
Trial Parameters
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Brief Summary
The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).
Eligibility Criteria
Inclusion Criteria: Patients V.1.1. Diseases Hematological malignancies confirmed histologically: * AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count \< 10 000 x109/mL); * MDS; * CML in CP or AP; * MPD not in blast crisis, * MDS/MPD overlap, * ALL in CR; * Multiple myeloma; * CLL; * Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease); * Hodgkin's disease with chemosensitive disease or responding to checkpoint inhibitors. \* Clinical situations • Theoretical indication for a standard allo-transplant, but not feasible because: * Age \> 50 yrs; * Unacceptable end organ performance; * The physician's decision; * The patient's decision * Underlying 'lower risk' disease, for which Reduced Intensity Conditioning is preferred (eg CLL, MCL) \* Other inclusion criteria * Male or female; fertile patients must use a reliable contraception method; * Age 18-75 yrs (children
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