Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Event-free survival
Study Overview
Brief Summary
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with hematological malignancy
- •Age<55 years
- •HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
- •Patients without a matched related donor
- •Patients eligible for an allogeneic HSCT from an alternative donor
- •Able to comply with the protocol
- •Written informed consent
- •Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria
- •Clinical or biological contraindication to allogeneic HSCT
- •Pregnant or breast-feeding women.
- •Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
- •Severe concomitant disease
Arms & Interventions
haploidentical related donors
Intervention: Hematopoietic stem cells transplantation (Procedure)
Matched unrelated donor
Intervention: Hematopoietic stem cells transplantation (Procedure)
Outcomes
Primary Outcomes
Event-free survival
Time Frame: 5 years
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
Secondary Outcomes
No secondary outcomes reported