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

ConditionsGraft Vs Host DiseaseGraft-versus-host-disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorChristopher Dvorak

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CliniMacs®

    Device

    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).

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Patients receiving allogeneic hematopoietic cell transplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

100-day incidence of Grade III-IV acute GVHD

The cumulative incidence of Grade III-IV acute GVHD at Day 100 will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.37 Patients with graft rejection will be censored.

Time frame
100 days

Secondary outcomes

1

30-day incidence of engraftment

The cumulative incidence of donor cell engraftment at 30 days will be summarized by incidence curves. Engraftment will be defined as ANC recovery (\>500 x 3 days) with evidence of donor myeloid cells on chimerism analysis, OR, for non-myeloablative HCTs, evidence of donor cells on chimerism analysis.

Time frame
30 days
2

1-year incidence of transplant-related mortality

The cumulative incidence of transplant-related mortality at 1-year will be summarized by incidence curves.

Time frame
12 months
3

1-year incidence of systemic steroid-requiring chronic GVHD

The cumulative incidence of systemic steroid-requiring chronic GVHD at 1-year will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.

Time frame
12 months
4

1-year incidence of autoimmunity requiring intervention with immunosuppressive agents as treatment.

The cumulative incidence of autoimmunity at 1-year will be summarized by incidence curves

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher Dvorak

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov
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