Ibrutinib and Rituxan for Chronic GVHD

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.

Timeline

Start

2019-12-16

Primary completion

2022-12-23

Completion

2022-12-23

Outcome

Outcome not reported

Stopped (Enrollment): “Low Recruitment”

Drugs

Indications