Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

Assistance Publique - Hôpitaux de Paris2 sites in 1 country184 target enrollmentNovember 20, 2017

ConditionsHematopoietic Stem Cell Transplant

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hematopoietic Stem Cell Transplant
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 184
Locations: 2
Primary Endpoint: Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2017

End Date

November 30, 2022

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

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