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

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.

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Key information

Conditions

Acute Leukemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non Hodgkin Lymphoma Paraproteinemias Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematopoietic stem cells transplantation

Procedure

Allogeneic Hematopoietic stem cells transplantation

Primary outcomes

Event-free survival

Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: HaploMUD-RIC

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Jul 23, 2018
Registry last updated: Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed