Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2017
novembre 2022
10 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | NGUYEN QUOC Stéphanie | 18/10/2025 10:09:13 | Contacter | ||
| HIA PERCY | NGUYEN QUOC Stéphanie | 18/10/2025 10:09:13 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/10/2025 10:09:13 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Saint Louis | |||||
Critères
Tous
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
- 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
- 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