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Center for International Blood and Marrow Transplant Research
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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

Study Materials

Protocol
Informed Consent Form
Minor Information Sheet