RecruitingPhase 2Phase 3NCT03818334

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

Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial

Sponsor

Hospital Israelita Albert Einstein

Enrollment

50 participants

Start Date

Nov 6, 2018

Study Type

INTERVENTIONAL

Conditions

Bone Marrow Transplant Complications

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).

Eligibility

Min Age: 1 YearMax Age: 75 Years

Inclusion Criteria4

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 Criteria7

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

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