Brief Title
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Official Title
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
Brief 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.
Detailed Description
Principal Investigators: The principal investigators (PIs) will be transplant physicians at all participating U.S. 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: In patients receiving a non-licensed CBU: - Assess incidence of transmission of infection - Assess incidence of serious infusion reaction - Determine 1 year overall survival 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
Study Type
Observational
Primary Outcome
Neutrophil recovery of ≥500/mm3 after cord blood transplantation
Condition
Hematologic Malignancies
Intervention
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Study Arms / Comparison Groups
Unlicensed CBU
Description: The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
99999
Start Date
October 2011
Completion Date
October 2041
Primary Completion Date
October 2041
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 the unlicensed CBU(s) - Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
John Miller, MD, PhD, , [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01351545
Organization ID
10-CBA
Responsible Party
Sponsor
Study Sponsor
Center for International Blood and Marrow Transplant Research
Collaborators
National Marrow Donor Program
Study Sponsor
John Miller, MD, PhD, Study Chair, NMDP/CIBMTR
Verification Date
August 2022