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Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

Study acronym: HLA
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 7 of 10 sitesv6
  2. Re-verified, no change to tracked fieldsv5
  3. Study title shortened, about 5 wordsv4
  4. Phase: Phase 3 to Phase 2v3 Show 9 more changesShow less
    • Trial status: Suspended to Recruiting
    • Enrollment target: 284 to 114
    • Interventions: Fludarabine (Drug), Melphalan (Drug), Thymoglobulin (Drug) to Cyclophosphamid (Drug), Fludarabine (Drug), Melphalan (Drug), Thymoglobulin (Drug)
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description shortened, about 20 words
    • Site details revised at 10 of 10 sites
    • Collaborator revised
    • Study title expanded, about 7 words
  5. Trial status: Recruiting to Suspended Sponsor's reason: Severe different but expected complications
    • Site details revised at 10 of 10 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Liege
40 trials monitored
See 1 trial at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Myeloid Leukemia (AML)
1,269 trials monitored
See 74 trials at risk
and 6 more diseases
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).
Trial Details
NCT Number NCT03852407
Lead Sponsor University of Liege
Collaborators: Belgian Hematological Society
Conditions
(from sponsor)		 Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes, Chronic Myeloid Leukemia in Remission, Myeloproliferative Syndrome, Myeloproliferative Disorder, Acute Lymphoid Leukemia in Remission, Multiple Myeloma, Chronic Lymphoid Leukemia +2 more
Related terms Graft vs Host Disease, Hematologic Neoplasms, Hodgkin Disease, Leukemia, B-Cell, Lymphoma, Non-Hodgkin, Multiple Myeloma, Myelodysplastic Syndromes, Myeloproliferative Disorders
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov