RecruitingPhase 2NCT06271616

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

A Phase II Study of Ibrutinib as Prophylaxis for Chronic Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)


Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ibrutinib (a medication that suppresses the immune system) can prevent chronic graft-versus-host disease (cGVHD) in people who have had a donor stem cell transplant. CGVHD is a serious complication where donor immune cells attack the recipient's body. **You may be eligible if...** - You are 18 or older - You are 50 to 110 days after a stem cell transplant from a matched or partially matched donor - Your blood counts are adequate (hemoglobin, neutrophils, platelets are above certain thresholds) - Your general health and function are good (Karnofsky score 70 or above) **You may NOT be eligible if...** - You already have active graft-versus-host disease - Your blood counts are too low - You have significant bleeding disorders or are on certain blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEchocardiography Test

Undergo echocardiography

DRUGIbrutinib

Given PO


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06271616


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