Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Stopped early · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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 levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL. The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.

Key facts

Study ID

NCT02200848

Run by

Georgetown University

People needed

5

Starts

2014-04-01

Expected to finish

2017-08-01

Last updated by the study team

2018-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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