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(Adult/Pediatric) A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
|Blood & Marrow Transplant (BMT)
- Primary Objective
- The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm³ after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
- Secondary Objectives (In patients receiving a non-licensed CBU):
- Assess incidence of transmission of infection
- Assess incidence of serious infusion reaction
- Determine 1 year survival after cord blood transplantation
- Assess cumulative incidence of acute GVHD grades II to IV and grades III to IV
- Assess cumulative incidence of chronic GVHD
- Determine platelet engraftment of >20,000 mcL and >50,000 mcL
- Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
- Signed informed consent (and signed assent, if applicable)
- Pediatric and adult patients of any age
- Patients who are receiving only licensed CBUs
- Cord blood transplant recipients at international transplant centers
- Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
- Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
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