Efficacy and safety of first-line therapy with chlorambucil, rituximab and lenalidomide (Revlimid®) (CR2) in elderly patients and young frail patients with advanced Chronic Lymphocytic Leukemia (CLL): a phase II trial
- Conditions
- Chronic Lymphatic LeukemiaCLL10024324
- Registration Number
- NL-OMON36713
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
* 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 <65 years and CIRS * 7
* Able to adhere to the study visit schedule and other protocol requirements.
* WHO performance status of * 2;
* Laboratory test results within these ranges: ANC * 1.0 x 10^9/l, Platelet count * 30 x 10^9/l, creatinine clearance * 60 ml/min, total bilirubin * 25 µmol/L, AST & ALT * 2 x ULN;
* Females of childbearing potential must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of starting lenalidomide
* Patients who are willing and capable to use adequate contraception during the therapy (all men, all pre-menopausal women). Patients must be able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan;
* Written informed consent
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part I:<br /><br>* Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended<br /><br>phase II dose (RDL) of Chlorambucil when combined with Rituximab and<br /><br>Lenalidomide.<br /><br>Part II:<br /><br>* CR+PR rate</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part I<br /><br>* Toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR)<br /><br>and neutropenic sepsis<br /><br>Part II<br /><br>* Improvement of response due to lenalidomide<br /><br>* Toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR)<br /><br>and neutropenic sepsis<br /><br>* Progression free survival (PFS; i.e. time from registration to progression or<br /><br>death from any cause, whichever comes first)<br /><br>* Event-free survival (EFS; i.e. time from registration to induction failure,<br /><br>progression or death from any cause, whichever comes first. </p><br>