Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

Status:

AVAILABLE

Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

Lead Sponsor:

Joanne Kurtzberg, MD

Collaborating Sponsors:

Duke University

Miltenyi Biotec, Inc.

Conditions:

Hematologic Malignancies

Inborn Errors of Metabolism Disorders

Eligibility:

All Genders

Up to 65 years

Brief Summary

The objective of this study is to make T-cell depleted stem cells from a family member who is a half match (haplo-identical) available on an expanded access basis to patients receiving one or two unre...

Detailed Description

The primary purpose of the study is to provide expanded access of T-cell depleted haplo-identical stem cells for patients receiving allogeneic transplantation from a related haplo-identical donor and ...

Eligibility Criteria

Inclusion

Have a consenting related haplo-identical (3/6, 4/6, or 5/6 if DRB1 mismatch) stem cell donor.
Have one or two available 4, 5, or 6/6 antigen matching unrelated UCB unit(s) that will deliver a total cell dose \>3.0 x 10e7 cells/kg. Patients who do not have a single UCB unit that will deliver the minimum required cell dose, two partially HLA-matched UCB units which together meet the minimum cell dose requirement, can be used for 1 transplant. These units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of HLA typing as indicated above). There is no limitation on maximum cell dose.
Have a high risk or refractory malignancy, or non-malignant disorder amenable to stem cell transplantation therapy.
Meet eligibility requirements for allogeneic transplant per institutional standard practices.
Have given written informed consent according to FDA guidelines (or consent of parent/legal guardian as applicable).
Be \<65 years of age at the time of study enrollment.

Exclusion

Have a consenting 8/8 or 10/10 allele matched, consenting, related or unrelated hematopoietic stem cell transplant (HSCT) donor.
Have a life expectancy of less than 3 months.
Have uncontrolled infections at time of cytoreduction.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01881334

Last Update

November 20 2025

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