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
Primary Investigator
Yanik, Gregory
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT01351545
UM Number
2011.073
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
11877
Secondary Protocol No
HUM00051074
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Hodgkin's Lymphoma
Leukemia, other
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Hematopoietic
Summary
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.
Eligibility: 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.
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