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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03595800

Acronym

HaploMUD-RIC

Enrollment

Registered

2018-07-23

Start date

2017-09-19

Completion date

2021-03-12

Last updated

2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Multiple Myeloma, Non Hodgkin Lymphoma

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.

Interventions

PROCEDUREHematopoietic stem cells transplantation

Allogeneic Hematopoietic stem cells transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Event-free survival	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026