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

Phase 3

Completed

• Conditions: Multiple Myeloma; Acute Leukemia; Non Hodgkin Lymphoma
• Interventions: Procedure: Hematopoietic stem cells transplantation

• Registration Number: NCT03595800
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-19
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Primary Completion: 2021-02-02
• Status Verified: 2021-03
• Study Completion: 2021-03-12
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
haploidentical related donors	Hematopoietic stem cells transplantation	-
Matched unrelated donor	Hematopoietic stem cells transplantation	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France