Overview

Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Status:
Recruiting
Trial end date:
2026-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Israelita Albert Einstein
Treatments:
Calcineurin Inhibitors
Cyclophosphamide
Thymoglobulin
Criteria
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