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Ibrutinib and Rituxan for Chronic GVHD | Clinical Trials | Clareo Health

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TERMINATEDPhase 2NCT04235036

Ibrutinib and Rituxan for Chronic GVHD

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 wi...

Lead sponsor: Northside Hospital, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Northside Hospital, Inc.

Collaborators

Pharmacyclics LLC.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 13, 2024Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment15

Start dateDec 2019

Last updatedDec 13, 2024

Condition

Graft Vs Host Disease

Locations shown

Northside Hospital

Atlanta, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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