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

Recruiting now · Phase 2/Phase 3

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

In brief

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).

Key facts

Study ID

NCT03818334

Run by

Hospital Israelita Albert Einstein

People needed

50

Starts

2018-11-06

Expected to finish

2026-11-01

Last updated by the study team

2019-02-01

Who can join

Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospita Israelita Albert Eintein — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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