Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06271616

Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

Led by Mayo Clinic · Updated on 2025-12-26

40

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD.

CONDITIONS

Official Title

Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 50 to 110 days post-transplant prior to registration
  • Age 18 years or older
  • HLA matched-related, matched unrelated donors (8/8 match) or HLA-mismatched-unrelated donors (7/8 match with single mismatch)
  • Karnofsky performance status of 70 or higher
  • Hemoglobin level of 8.0 g/dL or higher (untransfused) within 7 days before registration
  • Absolute neutrophil count of 1000/mm3 or higher without growth factor support within 7 days before registration
  • Platelet count of 50,000/mm3 or higher (untransfused) within 7 days before registration
  • Prothrombin time/INR/aPTT less than or equal to 1.5 times the upper limit of normal within 7 days before registration
  • Total bilirubin less than or equal to 1.5 times the upper limit of normal unless due to Gilbert's syndrome or other non-liver causes, or ALT and AST less than or equal to 2 times the upper limit of normal within 7 days before registration
  • Creatinine clearance of 40 ml/min or higher using Cockcroft-Gault formula within 7 days before registration
  • Adequate cardiac and pulmonary function at baseline including left ventricular ejection fraction of 45% or higher if clinically indicated
  • Pulmonary function with DLCO, FEV1, and FVC at 50% or higher of predicted values
  • Negative serum pregnancy test within 7 days before registration for persons of childbearing potential
  • Use of effective birth control methods and barrier methods during therapy and for 90 days after last dose for persons of childbearing potential
  • Provide written informed consent
  • Willingness to return to the enrolling institution for follow-up during active monitoring phase
Not Eligible

You will not qualify if you...

  • Uncontrolled acute GVHD at time of registration
  • Evidence of NIH chronic GVHD before or at time of registration
  • Relapsed or progressive disease compared to prior to transplant or registration
  • Uncontrolled active systemic infections including fungal, viral, bacterial, or others
  • Inability to swallow capsules or gastrointestinal conditions affecting drug absorption
  • Pregnant or nursing persons or persons of childbearing potential unwilling to use contraception
  • History of stroke or intracranial hemorrhage within 6 months prior to registration
  • Active central nervous system involvement with malignancy
  • Requirement for warfarin or other Vitamin K antagonists
  • Prior use of anti-thymocyte globulin, alemtuzumab, post transplant cyclophosphamide within 1 month of allograft
  • Use of strong CYP3A inhibitors within 7 days prior to first study dose or need for continuous use
  • Severe co-morbid illnesses interfering with safety assessment
  • Positive HIV antibody test
  • Uncontrolled intercurrent illnesses including infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues
  • Chronic liver disease with Child Pugh class B or C
  • Active hepatitis B or C infection
  • Receiving chemotherapy, immunotherapy, experimental therapy, or radiotherapy during study treatment except allowed antimicrobial prophylaxis and planned maintenance therapies
  • Other active malignancy within 5 years prior to registration except certain skin cancers or carcinoma-in-situ
  • History of myocardial infarction within 6 months or uncontrolled cardiac arrhythmias

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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