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Feasibility Study of CliniMACS® for Stem Cell Transplant

This study is looking at a device called CliniMACS® to help prevent graft-versus-host disease (GVHD) in patients receiving a stem cell transplant. GVHD is a serious complication where the donor's immune cells attack the patient's body. The CliniMACS® device helps remove certain immune cells (alpha/beta T-cells) from the donor's stem cells before transplant. This study is for patients up to 30 years old who need a stem cell transplant and have a suitable donor. The main goal is to see how many patients develop severe GVHD within 100 days after transplant. The study is currently unclear on its recruitment status and plans to enroll 90 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 90 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures GVHD incidence at 100 days, suggesting follow-up for at least this period.

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NCT04337515

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

Recruiting
NAUp to 30InterventionalTreatment
Christopher Dvorak
~90 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:CliniMacs®

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
100-day incidence of Grade III-IV acute GVHD
Measured over 100 days

Conditions

Graft Vs Host Disease
Graft-versus-host-disease

Explore related trials

Graft Versus Host Disease

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Christopher C Dvorak, MD · PRINCIPAL_INVESTIGATOR · Professor of Clinical Pediatrics

Who to contact

Christopher C. Dvorak, MD
[email protected]
415-476-0554
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 100-day incidence of Grade III-IV acute GVHD100 days

    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.