A Phase II Study of Ibrutinib as Prophylaxis for Chronic Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of ibrutinib in reducing the incidence of National Institutes of Health (NIH) moderate/severe chronic GVHD by 1-year post-registration. (Phase II Trial) SECONDARY OBJECTIVES: I. To determine the safety of ibrutinib when prescribed as prophylaxis for chronic GVHD. II. To determine the cumulative incidence of non-relapse mortality (NRM). III. To determine the cumulative incidence of relapse (CIR). IV. To determine the cumulative incidence of chronic GVHD (moderate/severe and all grades). V. To determine the cumulative incidence of late acute GV…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 50 to 110 days post-transplant prior to registration * Age ≥ 18 years * HLA matched-related, matched unrelated donors (defined as 8/8 \[class I: HLA A, B, C, and class II: DRB1\]), or HLA-mismatched-unrelated donors (defined as 7/8 \[with single mismatch at class I: HLA A, B, C, or class II: DRB1\]) * Karnofsky performance status (PS) ≥ 70 * Hemoglobin ≥ 8.0 g/dL (untransfused) (obtained ≤ 7 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (without growth factor support) (obtained ≤ 7 days prior to registration) * Platelet count ≥ 50,000/mm\^3 (…
Interventions
- ProcedureEchocardiography Test
Undergo echocardiography
- DrugIbrutinib
Given PO
Location
- Mayo Clinic in FloridaJacksonville, Florida