A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
|ClinicalTrials.gov Identifier: NCT00774345|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2008
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia||Drug: Lenalidomide Drug: Placebo||Phase 3|
This is a phase 3, randomized (computer assigned by chance to treatment arm), study being completed an multiple sites to compare the safety and efficacy (how well a drug works) of lenalidomide maintenance therapy to placebo (dummy capsule that contains no lenalidomide or active substances) maintenance therapy.
Patients are assigned by a computer with a 50/50 chance to receive placebo or lenalidomide study treatment. Study drug will be taken once each day until the patient discontinues the study. Patients will remain on study drug until progression of disease.
Patients will visit their study doctor every 28 days until disease progression to complete safety and efficacy assessments. Quality of life assessments will be completed every other month. If a patient who discontinue study drug prior to disease progression (i.e. due to an adverse reaction to the study drug), they will continue to visit the study doctor each month to complete the efficacy assessments up to progression of disease. Safety assessments may include laboratory blood tests, ECG tests and questions about any medical conditions or side effects experienced during the study. Efficacy assessments may include laboratory blood tests and focused physical exams.
Computed tomography (CT) scans along with blood tests and bone marrow samples will be collected to confirm if a patient has improvement of response while on study.
After disease progression, patients will be contacted every 12 weeks for survival information, next CLL treatments and quality of life questions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy (The Continuum Trial)|
|Actual Study Start Date :||January 27, 2009|
|Estimated Primary Completion Date :||October 27, 2020|
|Estimated Study Completion Date :||October 27, 2020|
Lenalidomide po qd on days 1-28 of a 28 day cycle
Lenalidomide capsules given orally on days 1-28 of a 28 day cycle
Other Name: Revlimid
Placebo Comparator: 2
Placebo capsules given orally on days 1-28 of a 28 day cycle
Placebo capsules given orally on days 1 - 28 of a 28 day cycle
- Overall Survival [ Time Frame: 8 years ]Overall survival is defined as the time from randomization to death of any cause
- 240 Events For Progression Free Survival [ Time Frame: 6 years ]Progression free survival (PFS) is defined as the time from randomization to disease progression or death due to any cause during or after the treatment period, whichever comes first
- The number, type, frequency and severity of adverse events (AEs) [ Time Frame: Up to 8 years; All AEs will be recorded by the Investigator(s) from the time of signing of informed consent ]An adverse event (AE) is any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values (as specified by the criteria below), regardless of etiology. Any medical condition that was present prior to study treatment and that remains unchanged or improved should not be recorded as an AE. If there is a worsening of that medical condition, this should be considered an AE.
- Tumor Response [ Time Frame: 6 years ]Tumor response is defined as the patient's best response to treatment as defined by the iwCLL guidelines.
- Duration of Response [ Time Frame: 6 years ]Duration of response is defined as the time from first evaluation of an improved response from the patient's baseline condition until progression of disease.
- Health Related Quality of Life-Fact Leukemia Survey Version 4.0 [ Time Frame: 6 years ]The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease.
- Health Related Quality of Life EQ5-D [ Time Frame: 6 years ]The standardized extended version of EQ-5D was designed for the collection of health state. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774345
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|Study Director:||Kenichi Takechita, MD||Celgene Corporation|