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
Phoenix/Scottsdale, Ariz., Jacksonville, Fla., Rochester, Minn.
Trial status: Open for Enrollment
Why is this study being done?
The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
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 Food and Drug Administration (FDA) licensed.
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 graft vs. host disease (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
Who is eligible to participate?
- 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