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

Institut Paoli-Calmettes9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Leukemia Non Hodgkin Lymphoma Multiple Myeloma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Event-free survival

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

Time frame: 5 years