Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL) (Rev-CLL)
|ClinicalTrials.gov Identifier: NCT00751296|
Recruitment Status : Terminated (Seven years of follow-up & final analysis done in Dec 2012.)
First Posted : September 11, 2008
Results First Posted : May 12, 2016
Last Update Posted : June 16, 2016
This study will assess the
- efficacy (response rate) of oral lenalidomide in the treatment of patients with symptomatic, previously untreated, chronic lymphocytic leukemia (CLL),
- toxicity of lenalidomide in patients with CLL as well as time to progression, stable disease duration and, if responses are observed, response duration.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukaemia||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.
Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle.Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Other Name: REVLIMID®
- To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis. ]
The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.
Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.
Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion).
- Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS). [ Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis. ]Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with >55% prolymphocytes)).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751296
|University Health Network - Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Christine I Chen, MD||University Health Network, Toronto|