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Center for International Blood and Marrow Transplant Research

10-CBA Study Page

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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

Activate Your Center

U.S. transplant centers are invited to participate in our IND protocol, 10-CBA, for access to unlicensed, minimally manipulated, cord blood units for FDA-specified disease indications. This protocol has been accepted by the FDA and approved by the NMDP IRB and is open for patient enrollment.  Sites have the option of submitting the study for IRB review to their local IRB or to the NMDP’s Single/Central IRB. The 10-CBA Study Team can assist sites in enrolling with the NMDP IRB.

To initiate the study at your site, complete the following steps. Send materials to the 10-CBA Study Team at 10-CBA@nmdp.org. 

  1. Submit Preliminary Activation Documents
    • Consent/assent forms 
    • Study Site Information Form
  2. Submit Protocol, Consent Forms, and Investigator Brochure to Your IRB
    • 10-CBA Protocol
    • Consent/assent forms (approved by NMDP). As a reminder, send your amended consent and assent forms in track changes format to 10-CBA Study Team    for approval prior to IRB submission.
  3. Submit Completed Participation Agreement Amendment 
    • Participation Agreement Amendment provided by the NMDP contracts department
  4. Submit Remaining Enrollment Materials as Available 

Center Documentation

Principal Investigator Documentation

  • CV – signed & dated within past year
  • Good Clinical Practice Training Documentation
  • Current Medical License
  • Financial Disclosure Form

Center IRB Documentation (keep original for your records)

  • IRB Approval letter
  • IRB Approved Informed Consent Form/Assent Form
  • IRB Roster or Documentation of IRB composition in compliance with GCP

Send Materials to 10-CBA@nmdp.org
Keep a copy of all documents for your records. 

Questions?
Contact 10-CBA Study Team at 10-CBA@nmdp.org