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
- Advanced previously untreated Chronic Lymphocytic Leukemia
- Registration Number
- NL-OMON23278
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedP.O. box 52013008 AE RotterdamTel: +31 10 7041560Fax: +31 10 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
1. Diagnosis of CLL without prior treatment;
2. Patients with symptomatic (according to IWCLL guidelines) stage A or stage B or stage C;
Exclusion Criteria
1. Patients that are unable or unwilling to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan;
2. Intolerance of exogenous protein administration;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For part I of the study:<br /><br>Dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended part II dose (RDL) of Chlorambucil when combined with Rituximab and Lenalidomide.<br><br /><br /><br>For part II of the study: CR+PR rate.
- Secondary Outcome Measures
Name Time Method For part I of the study:<br /><br>To evaluate toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR) and clinically relevant hematologic toxicity.<br><br /><br /><br>For part II of the study:<br /><br>1. To evaluate the efficacy of Lenalidomide monotherapy in patients without progressive disease after 6 cycles of CR2;<br /><br>2. To evaluate toxicity, especially tumor lysis syndrome (TLS), tumor flare reaction (TFR) and clinically relevant hematologic toxicity;<br /><br>3. To evaluate progression free survival;<br /><br>4. To evaluate event-free survival;<br /><br>5. To evaluate overall survival.