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OncoMatch/Clinical Trials/NCT03779854

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

Is NCT03779854 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for acute biphenotypic leukemia.

Phase 2RecruitingFred Hutchinson Cancer CenterNCT03779854Data as of Jun 2026

Treatment: Thiotepa · Fludarabine · Cyclophosphamide · Busulfan · Tacrolimus · MethotrexateThis phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

ThiotepaFludarabineCyclophosphamideBusulfanMethotrexate

Other

Tacrolimus

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Non-Hodgkin Lymphoma

Myeloproliferative Neoplasm

Demographics

Ages 0–26

Prior therapy

Must have received: cytotoxic chemotherapy

has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)

Cannot have received: allogeneic or autologous hematopoietic cell transplant

Prior allogeneic or autologous HCT

Lab requirements

Kidney function

Serum creatinine within normal range for age; if outside normal, CrCl > 40 mL/min/1.73m^2

Liver function

Total bilirubin <= 2 x ULN (unless value(s) > 2 x ULN are disease- or medication-related); ALT, AST <= 2 x ULN (unless value(s) > 2 x ULN are disease- or medication-related)

Cardiac function

Left ventricular ejection fraction (LVEF) at rest >= 40%

Total bilirubin <= 2 x ULN (unless value(s) > 2 x ULN are disease- or medication-related). ALT, AST <= 2 x ULN (unless value(s) > 2 x ULN are disease- or medication-related). Serum creatinine within normal range for age; if outside normal, CrCl > 40 mL/min/1.73m^2. Left ventricular ejection fraction (LVEF) at rest >= 40%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital of Los Angeles · Los Angeles, California
  • Children's National Medical Center · Washington D.C., District of Columbia
  • Children's Healthcare of Atlanta · Atlanta, Georgia
  • University of Iowa/Holden Comprehensive Cancer Center · Iowa City, Iowa
  • Dana Farber / Boston Children's Hospital · Boston, Massachusetts

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT03779854 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic or autologous hematopoietic cell transplant disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 26 years or younger and at least 0 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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