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

NCT03595800 | Completed Phase 3

• 1 other identifier: HaploMUD-RIC-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia; Non Hodgkin Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Study Arms (2)

haploidentical related donors

EXPERIMENTAL

Procedure: Hematopoietic stem cells transplantation

Matched unrelated donor

ACTIVE COMPARATOR

Procedure: Hematopoietic stem cells transplantation

Interventions

Hematopoietic stem cells transplantation PROCEDURE

Allogeneic Hematopoietic stem cells transplantation

Matched unrelated donor; haploidentical related donors

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Samia Harbi, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

• Didier Blaise

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: September 19, 2017
• Primary Completion: February 2, 2021
• Study Completion: March 12, 2021
• Last Updated: October 4, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)