Ibrutinib and Rituxan for Chronic GVHD

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT04235036
Phase
PHASE2
Status
Terminated

Conditions

  • Graft Vs Host Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 16, 2019
Status verified
Dec 2024
Primary completion
Dec 23, 2022
Completion
Dec 23, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

The Number of Patients Who Remain Off Immunosuppressive Therapy at 12 Months After the Initiation of Treatment. [ Time Frame: 12 months following initiation of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342-

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By research site
Northside Hospital· Atlanta, GA

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