Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant (ALTERGREF)

Assistance Publique - Hôpitaux de Paris

Status and phase

Unknown

Phase 2

Conditions

Hematopoietic Stem Cell Transplant

Treatments

Procedure: transplant from a haplo-identical donor

Procedure: transplant from a non related donor

Study type

Interventional

Funder types

Other

Identifiers

NCT03250546

P151001

Details and patient eligibility

About

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.

Enrollment

184 estimated patients

Sex

All

Ages

15 to 55 years old

Volunteers

No Healthy Volunteers

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