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Ibrutinib and Rituxan for Chronic GVHD

NCT04235036 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-13

Study results available
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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

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.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Northside Hospital, Inc.

    lead OTHER

Principal Investigators

  • Scott R Solomon, MD · Northside Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2022-12-23
Completion
2022-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235036 on ClinicalTrials.gov