Recruiting

Observational Study

Sponsor:

Christopher Dvorak

Code:

NCT04337515

Conditions

Graft Vs Host Disease

Graft-versus-host-disease

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

CliniMacs®

Study Details

Brief 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.

Conditions

Graft Vs Host Disease

Graft-versus-host-disease

Study ID

NCT04337515

Start date

Dec 19, 2019

Status verified date

Apr, 2026

Completion date

Jan 1, 2035

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients receiving allogeneic hematopoietic cell transplant

The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour).

The target dose of CD34+ cells is ≥20x10\^6/kg, but a minimum of

≥2.5x10\^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10\^5/kg.

Interventions

CliniMacs®

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).

Primary outcome measure

  • 100-day incidence of Grade III-IV acute GVHD [ Time Frame: 100 days ]

Central Contacts and Locations

Central contacts

Christopher C. Dvorak, MD

415-476-0554christopher.dvorak@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Christopher C Dvorak, MD

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Christopher C Dvorak, MD

More Information

Sponsor

Christopher Dvorak

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher Dvorak on 2026-04-13.