Ibrutinib and Rituxan for Chronic GVHD

Northside Hospital, Inc.

Status and phase: Terminated; Phase 2

Conditions: Graft Vs Host Disease

Treatments: Drug: Rituximab; Drug: Ibrutinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04235036

NSH 1219

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Rituximab + Ibrutinib

Experimental group

Description:

Eligible patients will be those with a first episode of symptomatic cGVHD, requiring systemic immunosuppression for control of symptoms. Following study entry, patients will be started on rituximab plus ibrutinib.

Treatment:

Drug: Ibrutinib

Drug: Rituximab