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

Chronic Graft Versus Host Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 GVHD (LA GVHD). VI. To determine 1-year overall survival (OS) from time of transplantation. VII. To determine NIH moderate/severe chronic GVHD and relapse free survival (CRFS).

VIII. To determine immune suppressive therapy required for therapy of chronic GVHD.

IX. To determine the cumulative incidence of complete immune suppression (IS) discontinuation.

CORRELATIVE OBJECTIVES:

I. To describe immune reconstitution post-transplant through serial measure of immune cell subsets and quantitative immunoglobulins.

II. To determine the efficiency of B-cell receptor (BCR) signaling blockades using multiparameter time of flight cytometry (CyTOF) that has been optimized for BTK and IL2-inducible T-cell kinase (ITK) phosphorylation assessment.

III. To investigate development of allogeneic antibodies and alloantigen specific B cells in F-M patients before and after ibrutinib.

IV. To investigate the effects ibrutinib treatment on development of allogeneic B cells.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-30 of each cycle. Cycles repeat every 30 days for up to 12 cycles on study. Additionally, patients undergo an echocardiography prior to registration and blood sample collection throughout study. ;

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Graft vs Host Disease

• NCT number: NCT06271616
• Study type: Interventional
• Source: Mayo Clinic
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Completion date: June 30, 2027