Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

Phase 2

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Procedure: transplant from a non related donor; Procedure: transplant from a haplo-identical donor

• Registration Number: NCT03250546
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).

It will use a Phase II, multicenter, prospective, randomized clinical trial.

By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Start: 2017-11-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
• Without HLA matched related or unrelated donor
• Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
• Having read and understood the information letter and signed the informed consent
• With health insurance coverage

Exclusion Criteria

• Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
• Performance Scale by the Eastern Cooperative Oncology Group (ECOG)> 2
• Severe uncontrolled infection
• Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction <50%)
• Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 N, creatinine > 150 mmol/L (except if related to malignancy)
• Previous active cancer in the last two years, except basal cell skin cancer and in situ carcinoma of the cervix
• Childbearing age woman refusing contraception
• Patients who did not accept the follow-up planned by the protocol
• Positive serology for HIV or Human T-Lymphotropic Virus (HTLV)-1, 2, or active viral infection by the Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
• Pregnant woman (positive β-HCG) or during lactation
• Adult patient on guardianship, or safeguard justice

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLA-9/10 MMUD group	transplant from a non related donor	-
Haplo-identical group	transplant from a haplo-identical donor	-

Primary Outcome Measures

Name	Time	Method
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD	2 year

Secondary Outcome Measures

Name	Time	Method
100 day engraftment	day 100

Trial Locations

Locations (2)

Saint Louis hospital; 🇫🇷 Paris, France

Service Hématologie Clinique; 🇫🇷 Paris, France