Clinical trial · Interventional
Extension of a 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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hematopoietic stem cells transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- haploidentical related donors
- interventionNames
- Procedure: Hematopoietic stem cells transplantation
- type
- ACTIVE_COMPARATOR
- label
- Matched unrelated donor
- interventionNames
- Procedure: Hematopoietic stem cells transplantation
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- 5 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available