RecruitingNot ApplicableNCT04337515

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

A Feasibility Study of Using the CiniMacs® Device for Alpha/Best T-Cell Depletion in Stem Cell Transplant Recipients

Sponsor

Christopher Dvorak

Enrollment

90 participants

Start Date

Dec 19, 2019

Study Type

INTERVENTIONAL

Conditions

Graft vs Host Disease Graft-Versus-Host Disease

Summary

Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.

Eligibility

Max Age: 30 Years

Inclusion Criteria4

Male or female 0-30 years of age at time of transplant admission
Documentation of a disease requiring HCT
A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria5

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
Patient with an anticipated life expectancy of <1 month
Patients with known hypersensitivity to murine (mouse) proteins or iron dextran

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Interventions

DEVICECliniMacs®

CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, HLA-identical MSD to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1).