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

Description

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.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 transplant

Trial 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 the unlicensed CBU(s) Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

Study Info

Interventions

Locations Recruiting

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