Chronic Lymphatic Leukemia CLL
Conditions
Interventions
Patients will be treated with 6 cycles of chlorambucil, rituximab, lenalidomide
followed by 6 cycles of lenalidomide
Sponsors
HOVON
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Diagnosis of CLL without prior treatment; * Patients with symptomatic stage A , according to IWCLL guidelines or stage B or stage C * Age * 65 years at the time of signing the informed consent form, or age
Exclusion criteria
Exclusion criteria: * Patients that are unable or unwilling to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan; * Intolerance of exogenous protein administration; * Hepatitis B Ag positive, Hepatitis C positive and/or HIV positive patients; * Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP); * Active fungal, bacterial, and/or viral infection; * Pregnant or breast-feeding females (lactating females must agree not to breast feed while taking lenalidomide); * Use of any other experimental drug or therapy within 28 days of baseline; * Known hypersensitivity and/or serious adverse reactions to lenalidomide or similar drugs; * Any prior use of lenalidomide; * Concurrent use of other anti-cancer agents or treatments; * Uncontrolled hyperthyroidism or hypothyroidism; * Patients with history of idiopathic deep venous thrombus and/or pulmonary embolism within last three years; * Neuropathy * Grade 2; * History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin; squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b) * Current inclusion in other clinical trials.; * Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I: * Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RDL) of Chlorambucil when combined with Rituximab and Lenalidomide. Part II: * CR+PR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I * Toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR) and neutropenic sepsis Part II * Improvement of response due to lenalidomide * Toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR) and neutropenic sepsis * Progression free survival (PFS; i.e. time from registration to progression or death from any cause, whichever comes first) * Event-free survival (EFS; i.e. time from registration to induction failure, progression or death from any cause, whichever comes first. | — |
Countries
Netherlands
Outcome results
None listed