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
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.
B-cell Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia Following Second Line Therapy (THE CONTINUUM TRIAL)|
- Overall Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]Overall survival is defined as the time from randomization to death of any cause
- 240 Events For Progression Free Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).
- Health Related Quality of Life EQ5-D [ Time Frame: 6 years ] [ Designated as safety issue: No ]The standardized extended version of EQ-5D was designed for the collection of health state values using a VAS rating scale - a vertical 20 cm visual analogue scale with the end points labelled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. 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
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774345
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
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|Study Director:||Oliver Kong, MD||Celgene Corporation|