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Ibrutinib and Rituxan for Chronic GVHD

NCT ID: NCT04235036

Last Updated: 2024-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2022-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Graft Vs Host Disease

Keywords

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ibrutinib rituximab cGVHD chronic GVHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab + Ibrutinib

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.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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).

Ibrutinib

Intervention Type DRUG

Ibrutinib is given orally every day (28-day cycles) for a total of 12 cycles.

Interventions

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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).

Intervention Type DRUG

Ibrutinib

Ibrutinib is given orally every day (28-day cycles) for a total of 12 cycles.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacyclics LLC.

INDUSTRY

Sponsor Role collaborator

Northside Hospital, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott R Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Northside Hospital

Locations

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Northside Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NSH 1219

Identifier Type: -

Identifier Source: org_study_id