A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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
Sponsor: Center for International Blood and Marrow Transplant Research
This observational or N/A phase trial investigates Acute Lymphoblastic Leukemia (ALL) and Acute Myelogenous Leukemia (AML or ANLL) and is currently actively recruiting participants. Center for International Blood and Marrow Transplant Research leads this study, which shows 61 recorded versions since 2011 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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
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
Status Flow
Change History
61 versions recorded-
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First recorded
Oct 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Center for International Blood and Marrow Transplant Research
- National Marrow Donor Program
For direct contact, visit the study record on ClinicalTrials.gov .