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 (HaploMUD-RIC)

Institut Paoli-Calmettes

Status and phase

Completed

Phase 3

Conditions

Acute Leukemia

Multiple Myeloma

Non Hodgkin Lymphoma

Treatments

Procedure: Hematopoietic stem cells transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03595800

HaploMUD-RIC-01

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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