Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 284
Summary
- Conditions
- Acute Lymphoid Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Chronic Lymphoid Leukemia
- Chronic Myeloid Leukemia in Remission
- Hodgkin Lymphoma
- Multiple Myeloma
- Myelodysplastic Syndromes
- Myeloproliferative Disorder
- Myeloproliferative Syndrome
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrel...
This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years.
Tracking Information
- NCT #
- NCT03852407
- Collaborators
- Belgian Hematological Society
- Investigators
- Principal Investigator: Frédéric Baron, MD,Ph Centre Hospitalier Universitaire de Liège
Get Well Soon