Clinical trial NCT04235036: Ibrutinib and Rituxan for Chronic GVHD
Official title: Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Graft Vs Host Disease
Keywords: ibrutinib
rituximab
cGVHD
chronic GVHD
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Pharmacyclics LLC.
First posted: 2020-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Patients Who Remain Off Immunosuppressive Therapy at 12 Months After the Initiation of Treatment.
timeFrame: 12 months following initiation of treatment
Secondary outcomes:
measure: The Number of Patients Who Respond to Treatment Assessed by NIH Response Criteria Working Group Report.
timeFrame: 12 months following initiation of treatment
measure: How Long it Takes for Patients to Discontinue Treatment Defined as the Date All Systemic Immunosuppressive Therapy is Discontinued After Resolution of GVHD.
timeFrame: Up to 32 months
measure: How Many Patients Are Still Alive Without the Requirement for Second-line cGVHD Therapy Measured by Overall Survival at 12 Months Following the Initiation of Treatment.
timeFrame: 12 months following initiation of treatment
measure: How Many Patients Have Not Relapsed Measured by Progression-free Survival at 12 Months Following the Initiation of Treatment.
timeFrame: 12 months following initiation of treatment
measure: How Many Patients Have Not Died Measured by Overall Survival at 12 Months Following the Initiation of Treatment.
timeFrame: 12 months following initiation of treatment
measure: Number of Patients With Treatment-related Adverse Events Grade 3 or Greater as Assessed by CTCAE v.4.0.
timeFrame: 12 months following initiation of treatment
measure: Number of Patients With Treatment-related Adverse Events Total as Assessed by CTCAE v.4.0.
timeFrame: 12 months following initiation of treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Northside Hospital
name: Scott R Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: