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Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
RECRUITINGPhase 2/3Sponsored by Hospital Israelita Albert Einstein
Actively Recruiting
PhasePhase 2/3
SponsorHospital Israelita Albert Einstein
Started2018-11-06
Est. completion2021-11-01
Eligibility
Age1 Year – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03818334
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
Age: 1 Year – 75 YearsHealthy volunteers accepted
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
Conditions6
Bone Marrow Transplant ComplicationsCancerEngraft FailureGraft-versus-host-diseaseImmunologic SuppressionInfection Viral
Interventions2
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Actively Recruiting
PhasePhase 2/3
SponsorHospital Israelita Albert Einstein
Started2018-11-06
Est. completion2021-11-01
Eligibility
Age1 Year – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03818334