Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will recei
| Condition(s) | Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral, Engraft Failure, Immunologic Suppression |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG). |
| Who can participate | Inclusion Criteria: * Men and Women of Any Age * Indication for an HSCT without matched sibling donor * Have a matched unrelated donor (HLA 10 x 10 or 9 x 10) * Hematological malignancy Exclusion Criteria: * Acute leukemias not in complete response (that is \> 5% blast in the bone marrow) * Chemorefractory lymphoproliferative disease * Active uncontrolled infection * HCT-CI \> 3 * Severe organic disfunction (heart ejection fraction \< 45%, glomerular filtration rate \< 50 mL.hour, pulmonary DLCO \< 50%) * Previous allogeneic bone marrow transplantation * Contraindication to cyclophosphamide or ATG |
| Ages | 1 Year to 75 Years |
| Sex | All |
| Lead sponsor | Hospital Israelita Albert Einstein |
| Locations | São Paulo, São Paulo, Brazil |
| Start date | 2018-11-06 |
| NCT ID | NCT03818334 |
| Official listing | https://clinicaltrials.gov/study/NCT03818334 |