A Multicenter Access and Distribution P… | Clinical Trial

Key information

Conditions

Hematologic Malignancies Acute Lymphoblastic Leukemia (ALL) Acute Myelogenous Leukemia (AML or ANLL) Anemia Anemia, Aplastic Autoimmune Diseases Bone Marrow Diseases Bone Marrow Failure Disorders Chronic Disease Chronic Myelogenous Leukemia (CML) Disease Disease Attributes Disorders of the Immune System Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Histiocytic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Inherited Abnormalities of Erythrocyte Differentiation or Function Inherited Abnormalities of Platelets Inherited Disorders of Metabolism Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma/ Plasma Cell Disorder (PCD) Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkin Lymphoma Other Acute Leukemia Other Leukemia Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Severe Aplastic Anemia

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

Drug

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 outcomes

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.

The primary objective of this access and distribution protocol 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 FDA licensed.
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.

The primary objective of this access and distribution protocol 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 FDA licensed.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Fosberg, B.A.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

National Marrow Donor Program

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2041
Study completion: 2041
First posted: May 11, 2011
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed