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

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

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age1-75

SponsorHospital Israelita Albert Einstein

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Acute leukemias not in complete response (that is > 5% blast in the bone marrow)

Chemorefractory lymphoproliferative disease

Active uncontrolled infection

HCT-CI > 3

Trial design

Treatments tested in this trial

Cyclophosphamide
ATG

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Hospital Israelita Albert Einstein

Lead sponsor

Source ClinicalTrials.gov