Details

Details

Title (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

IRB CBMT 1Z11

CC CC00162

Hospital Main Campus

Stage N/A

Phase N/A

Disease Blood & Marrow Transplant (BMT), Hematologic Malignancy

Description

Description

  1. 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.
  2. 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
Inclusion Criteria

Inclusion Criteria

  1. Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  2. Signed informed consent (and signed assent, if applicable)
  3. Pediatric and adult patients of any age
Exclusion Criteria

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 the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated