protocolSection identificationModule nctId: NCT06271616, orgStudyIdInfo id: MC1873, secondaryIdInfos id: NCI-2024-01061, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 18-008754, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Graft Versus Host Disease, conditions: Hematopoietic and Lymphatic System Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Echocardiography, interventions name: Ibrutinib, outcomesModule primaryOutcomes measure: Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD), secondaryOutcomes measure: Cumulative incidence of non-relapse mortality (NRM), secondaryOutcomes measure: Cumulative incidence of relapse, secondaryOutcomes measure: Cumulative incidence of moderate/severe chronic GVHD, secondaryOutcomes measure: Cumulative incidence of moderate/severe chronic GVHD, secondaryOutcomes measure: Cumulative incidence of chronic GVHD of all grades, secondaryOutcomes measure: Cumulative incidence of late acute GVHD, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: NIH moderate/severe GVHD and relapse free survival (CRFS), secondaryOutcomes measure: Type and duration of immune suppressive therapy, secondaryOutcomes measure: Cumulative incidence of complete immune suppression (IS) discontinuation, secondaryOutcomes measure: Incidence of adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Mohamed A. Kharfan Dabaja, M.D., M.B.A., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False