A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs).
- Who it may be relevant to
- Registry conditions: Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug 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
Primary outcome measures
- Neutrophil recovery of ≥500/mm3 after cord blood transplantation [Time frame: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.]
- Neutrophil recovery of ≥500/mm3 after cord blood transplantation [Time frame: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 142 centers
- University of Alabama at Birmingham — Birmingham
- Banner MD Anderson Cancer Center — Gilbert
- Phoenix Children's Hospital — Phoenix
- Mayo Clinic Arizona (adults) — Phoenix
- University of Arizona Medical Center - Tucson — Tucson
- Arkansas Children's Hospital — Little Rock
- City of Hope — Duarte
- Children's Hospital of Los Angeles — Glendale
- … and 134 more centers
Identifiers
NCT: NCT01351545 · 10-CBA