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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

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