Status:
TERMINATED
Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose le...
Detailed Description
Treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. A small expansion cohort to include 10 patients will follow once the recommended phase II dose is fou...
Eligibility Criteria
Inclusion
- Previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment
- No prior systemic treatment within 4 weeks of enrollment
- No corticosteroids within 2 weeks prior to study entry
- Measurable disease must be present
- No concomitant anti-cancer therapies
- ECOG status \</= 2
- Patients with HIV infection are eligible
- Patients with treated CLL or SLL in CNS are eligible
- Non-pregnant and non-nursing
- Life expectancy greater than 60 days
- Adequate bone marrow, kidney and liver function
- No major surgery within 28 days or minor surgery within 5 days of starting treatment
Exclusion
- History od Richter's transformation
- History of prior allogeneic transplant
- Radioimmunotherapy within 1 year of enrollment
- Prior Bruton's tyrosine kinase inhibitor or lenalidomide
- History of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity
- active or uncontrolled autoimmune hemolytic anemia or ITP
- Transfusion-dependent thrombocytopenia or bleeding disorders
- Active hepatitis B or C infections
- History of known Human Anti-Chimeric Antibody positivity
- History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
- History of uncontrolled seizures
- Autoimmune disorder that requires active immunosuppression
- Stroke or intracranial hemorrhage within last 6 months
- History of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any Class 3 or 4 heart disease in the last 6 months
- No prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ
- using warfarin or similar Vitamin K antagonists Unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02200848
Start Date
April 1 2014
End Date
August 1 2017
Last Update
January 12 2018
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007