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