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

Recruiting
1 - 75 years of age
Both
Phase 2/3
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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).

Eligibility

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

Study details

Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral, Engraft Failure, Immunologic Suppression

NCT03818334

Hospital Israelita Albert Einstein

25 January 2024

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