Status:
UNKNOWN
Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hematopoietic Stem Cell Transplant
Eligibility:
All Genders
15-55 years
Phase:
PHASE2
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03250546
Start Date
November 20 2017
End Date
November 30 2022
Last Update
February 19 2019
Active Locations (2)
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1
Saint Louis hospital
Paris, France, 75010
2
Service Hématologie Clinique
Paris, France, 75013