Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Georgetown University
With
National Cancer Institute (NCI)
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 found.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
