What is this study trying to find out about hematologic malignancies and related disorders?

This study aims to observe how unlicensed cryopreserved cord blood units are used in patients with blood cancers and other blood disorders. It focuses on recovery of white blood cells, survival, infection rates, and graft-versus-host disease after transplantation. The research is led by the Center for International Blood and Marrow Transplant Research to better understand outcomes in these patients.

Who may be eligible for this hematologic malignancies clinical trial?

Patients of any age with disorders affecting their blood-forming system may be eligible. Participants include both children and adults receiving unlicensed cord blood units for transplantation. People receiving only licensed units or enrolled in another investigational protocol are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this hematologic malignancies clinical trial?

Study-related care, including the use of the cord blood units and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

All Genders

ID01351545

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

Led by Center for International Blood and Marrow Transplant Research · Updated on 2026-06-04

99999

Participants Needed

142

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood-forming system. This observational study aims to evaluate outcomes such as the recovery of a certain level of white blood cells after transplantation, as well as the incidence of infections, infusion reactions, survival rates, and graft-versus-host disease over time. The study involves patients receiving unlicensed CBUs at multiple U.S. transplant centers. These CBUs are used for patients with hematologic malignancies and other blood disorders. The protocol collects data on patients who receive these unlicensed transplant units, without administering a new treatment but observing the outcomes after transplantation. Participants will be monitored for neutrophil recovery at 60 and 100 days post-transplant, along with assessments of infection transmission, infusion reactions, survival one year after transplant, and occurrences of acute and chronic graft-versus-host disease. Platelet engraftment levels will also be tracked. The study includes patients of any age and follows them through the transplantation and recovery process to gather information on these key outcomes.

CONDITIONS

Brief Title

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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

Research Team

Elizabeth Fosberg, B.A.

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