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Could a cancer drug ease a devastating transplant complication in kids?

NCT ID NCT03790332

Disease control Sponsor: Pharmacyclics LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug ibrutinib in 59 children with chronic graft-versus-host disease (cGVHD), a serious condition that can occur after a stem cell transplant. The goal was to find the best dose and see if it is safe. Participants had moderate or severe cGVHD that did not improve with other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

59 people

The number who actually took part.

Started

Nov 2018

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Eligibility: Inclusion Criteria: 1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy 2. Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression 3. History of allogeneic stem cell transplantation 4. Age * Part A: ≥1 to \<12 years of age at the time of enrollment * Part B: ≥1 to \<22 years of age at the time of enrollment 5. Karnofsky or Lansky (subjects \<16 years of age) performance status ≥60 Key Eligibility: Exclusion Criteria: 1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD 2. Received an investigational agent within 28 days before enrollment. 3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment 4. Progressive underlying malignant disease or active post-transplant lymphoproliferative disease 5. Any uncontrolled infection or active infection requiring ongoing systemic treatment 6. Known bleeding disorders 7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic graft versus host disease

Contacts and locations

Locations

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CHU Nantes - Hopital Enfant Adolescent

    Nantes, 44093, France

  • CHU Sainte-Justine

    Montreal, Quebec, H3T1C5, Canada

  • Cancer Center for Children. The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Charite-Universitaetsmedizin Berlin

    Berlin, 13353, Germany

  • Children's Hospital

    Aurora, Colorado, 80045, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

    Roma, 00165, Italy

  • Federal State Budgetary Educational Institution of Higher Professional Education "LP.Pavlov First Saint Petersburg State Medical

    Saint Petersburg, 197022, Russia

  • Federal State Budgetary Institution "Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

    Moscow, 117997, Russia

  • Fondazione MBBM-Clinica Pediatrica

    Monza, 20900, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hadassah Medical Centre

    Jerusalem, 9112001, Israel

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hospital Universitario Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hôpital Robert-Debré Ap-Hp

    Paris, 75019, France

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Princess Maxima Center

    Utrecht, 3584 CS, Netherlands

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita

    Turin, 10126, Italy

  • Safari Day Care, Great Ormond Street Hospital

    London, Greater London, WC1N 3JH, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Schneider Children's Medical Center in Israel

    Petah Tikva, 4920235, Israel

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul Saint Mary's Hospital

    Seoul, 06591, South Korea

  • St. Anna Kinderspital

    Vienna, 1090, Austria

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2729, United States

  • Sydney Children's Hospital

    Randwick, 2031, Australia

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Edmond and Lily Safra Children's Hospital

    Ramat Gan, 5262100, Israel

  • The Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • U.O.C. Ematologia Oncoematologia Pediatrica

    Pavia, PV, 27100, Italy

  • University of California

    San Francisco, California, 94158, United States

  • University of Minnesota Masonic Children's Hospital

    Minneapolis, Minnesota, 55454, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • children's and Women's Health Centre of British Columbia

    Vancouver, British Columbia, V6H 3V4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.