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Cancer Answer Line:

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CBMT 1Z11   |   CC00162
(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
Disease(s)
Bone Marrow Transplant (BMT)
Hematologic Malignancy
Hospital(s)
Main Campus
Phase(s)
N/A
Stage(s)
N/A
Type(s)
Observational
Drug(s)
Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday

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 graft rejection
    • 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
    • Determine CBU-derived engraftment
Inclusion Criteria
  1. Patients with FDA-specified indications (see Appendix B for further details):
    • Hematological malignancies
    • Certain lysosomal storage and peroxisomal enzyme deficiency disorders
      • Hurler syndrome (MPS I)
      • Krabbe Disease (Globoid Leukodystrophy)
      • X-linked Adrenoleukodystrophy
    • Primary immunodeficiency diseases
      • Bone marrow failure
      • Beta-thalassemia
  2. Signed informed consent (and signed assent, if applicable)
  3. Pediatric and adult patients of any age
Exclusion Criteria
  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers

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