10-CBA Study Page
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 (10-CBA).
Study Synopsis
Sponsor: NMDP
Principal Investigators: The principal investigators (PIs) are transplant physicians at all participating US transplant centers.
Study Design: 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.
Primary Objective: The primary objective 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.
Secondary Objectives:
- Assess incidence of transmission of infection
- Assess incidence of serious infusion reaction
- Determine overall survival 1 year 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
Eligibility Criteria:
Inclusion Criteria
- Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
- Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
- Pediatric and adult patients of any age
Exclusion Criteria
- 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 each unlicensed CBU
- Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Treatment Description: Treatment, including pre-transplant conditioning and GVHD prophylaxis, will occur per each transplant center’s specifications.
Accrual Objective: In this access and distribution protocol, US patients undergoing transplantation with unlicensed CBUs will be enrolled and there is no accrual maximum.
Accrual Period: The accrual period is open-ended.
Study Contacts: 10-CBA Study Email: 10-CBA@nmdp.org