Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title: Optimizing Post-allogeneic Hematopoietic Cell Transplant Outcomes for Lymphoma Using Ibrutinib

Status Completed

Clinical Trial Summary

This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To study the use of ibrutinib starting between day 60 and day 90 after allogeneic hematopoietic cell transplant (HCT) until 12 months post hematopoietic cell transplant to improve the progression-free survival (PFS) at 12 months post hematopoietic cell transplant by 25% compared to historical controls.

SECONDARY OBJECTIVES:

I. To increase the incidence of successful outcome (defined as lack of requirement of second line therapy for acute graft-versus-host disease, lack of National Institutes of Health [NIH] severe chronic graft-versus-host disease, lack of progression or relapse of chronic lymphocytic leukemia/mantle cell lymphoma [MCL], lack of death from disease or non-relapse causes) to at least 60% at 1 year post hematopoietic cell transplant. (Cohort A) II. To study the safety and tolerability of ibrutinib post hematopoietic cell transplant in patients with non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma. (Cohort A and B combined) III. To study the incidence of grade 3-4 acute graft-versus-host disease in the first 6 months post hematopoietic cell transplant in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) IV. To study the incidence of second line therapy (systemic only) for acute graft-versus-host disease in the first 6 months post hematopoietic cell transplant in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) V. To study the incidence of recurrent acute graft-versus-host disease in the first 6 months post hematopoietic cell transplant in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) VI. To study the incidence and severity of chronic graft-versus-host disease in the first 12 months post hematopoietic cell transplant in patients with not-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) VII. To study the incidence of lung involvement with graft-versus-host disease in the first 12 months post hematopoietic cell transplant in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) VIII. To study the incidence of sclerotic skin chronic graft-versus-host disease in the first 12 months post hematopoietic cell transplant in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. (Cohort A and B combined) IX. To study the incidence of infectious deaths not related to graft-versus-host disease in patients with non-Hodgkin and Hodgkin lymphoma. (Cohort A and B combined)

TERTIARY OBJECTIVES:

I. To study the association of minimal residual disease (MRD) as detected by immunoglobulin heavy chain (IgH) sequencing prior to starting ibrutinib and compare to post ibrutinib at month 6, 9 and 12 after HCT. (Cohort A)

II. To study the impact of onset of new acute or chronic graft-versus-host disease on minimal residual disease. (Cohort A)

III. To study the association of T-cell clonality by T cell receptor (TCR) Vb sequencing prior to starting ibrutinib and compare to post ibrutinib at month 6, 9 and 12 after hematopoietic cell transplant. (Cohort A)

IV. To study the impact of onset of new acute or chronic graft-versus-host disease on T cell receptor sequencing. (Cohort A)

V. To study the association of B cell receptor signaling pathways and immune function with response by single cell mass cytometry prior to starting ibrutinib and compare to post ibrutinib at month 6, 9 and 12 after hematopoietic cell transplant. (Cohort A)

VI. To study the association of single cell mass cytometry that investigates B cell receptor signaling and its association with new acute or chronic graft-versus-host disease on B-cell receptor (BCR) signaling. (Cohort A)

OUTLINE:

Beginning between 60-90 days post donor stem cell transplant, patients receive ibrutinib orally (PO) once daily (QD) until 1 year post donor stem cell transplant in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up for 1 year. ;

Related Conditions & MeSH terms

• Blastoid Variant Mantle Cell Lymphoma
• Hodgkin Disease
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Recurrence
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Follicular Lymphoma
• Recurrent Hodgkin Lymphoma
• Recurrent Mantle Cell Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Follicular Lymphoma
• Refractory Hodgkin Lymphoma
• Refractory Mantle Cell Lymphoma

• NCT number: NCT02869633
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Completion date: October 2023