Birmingham, Alabama 35233


Purpose:

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.


Study summary:

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


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


NCT ID:

NCT01351545


Primary Contact:

Study Chair
John Miller, MD, PhD
NMDP/CIBMTR

Alisha Mussetter
Phone: 763-406-4863
Email: amussett@NMDP.ORG


Backup Contact:

Email: ncarlisa@NMDP.ORG
Nicole Carlisano
Phone: 763-406-8752


Location Contact:

Birmingham, Alabama 35233
United States

Joseph Chewning, MD
Email: jchewning@peds.uab.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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