NCT04235036

Ibrutinib and Rituxan for Chronic GVHD

Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All other assessments will be done at the physician's discretion or institutional standards. All patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. The primary endpoint will be the proportion of patients that are alive and off all systemic IST at 12 months following initiation of treatment.

Conditions

• Graft Vs Host Disease

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab is given IV weekly x 4 weeks (to be started on study day 7 ± 3 days), then IV q3months x 4 doses (months 4, 7, 10, 13).
DRUG	Ibrutinib	Ibrutinib is given orally every day (28-day cycles) for a total of 12 cycles.

Timeline

• Start date: 2019-12-16
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2020-01-21
• Last updated: 2024-12-13
• Results posted: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study