🏛️ Verified NIH Record • Updated 2026-07-27

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant (NCT03779854)

Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Fred Hutchinson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

This 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (35 items) and avoid the listed exclusions (14 items).

Location: Children's Hospital of Los Angeles — Los Angeles, California

Age range: 6 Months to 26 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.
  • Patients on other experimental protocols for the prevention of GVHD.
  • Patient body weight:
  • Matched related donor (MRD): \> 100 kg are ineligible
  • Matched unrelated donor (MUD): \> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.
  • HIV-positive.
  • Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.
  • Life expectancy \< 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).
  • Significant medical condition that would make recipient unsuitable for HCT.
  • Prior allogeneic or autologous HCT.
  • Females who are pregnant or breastfeeding.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 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
  • UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) — Cleveland, Ohio
  • Cleveland Clinic Foundation — Cleveland, Ohio
  • Oregon Health and Science University — Portland, Oregon
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
  • Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (206) 667-6572

Email: mbleakle@fredhutch.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗