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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2021-03-12

Brief Summary

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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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Detailed Description

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Conditions

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Acute Leukemia Non Hodgkin Lymphoma Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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haploidentical related donors

Group Type EXPERIMENTAL

Hematopoietic stem cells transplantation

Intervention Type PROCEDURE

Allogeneic Hematopoietic stem cells transplantation

Matched unrelated donor

Group Type ACTIVE_COMPARATOR

Hematopoietic stem cells transplantation

Intervention Type PROCEDURE

Allogeneic Hematopoietic stem cells transplantation

Interventions

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Hematopoietic stem cells transplantation

Allogeneic Hematopoietic stem cells transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No