Ibrutinib and Rituxan for Chronic GVHD

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    35
  • sponsor
    Northside Hospital, Inc.
Updated on 7 September 2021
corticosteroids
rituximab
immunosuppressive agents
immunosuppression
ibrutinib
chronic graft versus host disease

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.

Details
Condition Graft-Versus-Host Disease, Graft-Versus-Host Disease (GVHD), graft versus host disease, graft-versus-host-disease
Treatment Rituximab, Ibrutinib
Clinical Study IdentifierNCT04235036
SponsorNorthside Hospital, Inc.
Last Modified on7 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

First episode of systemic immunosuppression-requiring cGVHD, defined as classic or overlap cGVHD by the NIH consensus criteria
Previously untreated cGVHD, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
KPS 70% or greater

Exclusion Criteria

Late persistent or recurrent acute GVHD
Active uncontrolled infection
History of HIV infection; active HBV or HCV infection
Inability to tolerate oral medications
Progressive or recurrent malignancy following allogeneic transplant
Exposure to BTK inhibitor following transplant
Received prior treatment with ECP for cGVHD
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