Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic … (NCT01002755) | Clinical Trial Compass
CompletedPhase 2
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
United States36 participantsStarted 2010-01-19
Plain-language summary
This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and ofatumumab may work better in treating participants with chronic lymphocytic leukemia or small lymphocytic lymphoma
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Understand and voluntarily sign an informed consent
* Patients with CLL or small lymphocytic lymphoma (SLL) with active disease: B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the National Cancer Institute (NCI)-sponsored working group 1) weight loss of \> 10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy \> 5 cm in diameter
* Prior treatment with purine analog based chemotherapy or chemoimmunotherapy
* Platelet count \> or = to 30,000 mm\^3
* Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2
* Creatinine clearance \> 30 ml/min (calculated by 24 hours urine collection) or a glomerular filtration rate (GFR) \> 30 ml/min estimated using the Cockcroft-Gault equation
* Total bilirubin less or equal to 2 mg/dl
* Alanine aminotransferase (ALT) less or equal to two times the upper limit of normal
* Disease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable e…