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)
Overview
- Phase
- Phase 3
- Intervention
- Lenalidomide
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Sponsor
- Celgene
- Enrollment
- 317
- Locations
- 240
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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. Subjects currently on lenalidomide treatment will discontinue lenalidomide treatment immediately and complete the Treatment Discontinuation assessment. The subjects will then transition to the survival follow-up period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must understand and voluntarily sign an informed consent form.
- •Must be greater than or equal to 18 years at the time of signing the informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia \[Hallek, 2008\]).
- •Must have been treated with one of the following in first and/or second line:
- •a purine analog-containing regimen
- •a bendamustine-containing regimen
- •an anti-CD20 antibody-containing regimen
- •a chlorambucil-containing regimen
- •an alemtuzumab-containing regimen (for those subjects with a 17p deletion)
Exclusion Criteria
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •Active infections requiring systemic antibiotics.
- •Systemic infection that has not resolved \> 2 months prior to initiating lenalidomide treatment in spite of adequate anti-infective therapy
- •Autologous or allogeneic bone marrow transplant as second-line therapy.
- •Pregnant or lactating females.
- •Systemic treatment for B-cell CLL in the interval between completing the last cycle of second-line induction therapy and randomization.
- •Participation in any clinical study or having taken any investigational therapy for a disease other than CLL within 28 days prior to initiating maintenance therapy.
- •Known presence of alcohol and/or drug abuse.
- •Central nervous system involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
- •Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥5 years. Exceptions include the following:
Arms & Interventions
Experimental: 1
Lenalidomide po qd on days 1-28 of a 28 day cycle
Intervention: Lenalidomide
Placebo Comparator: 2
Placebo capsules given orally on days 1-28 of a 28 day cycle
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to approximately 11 years
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Secondary Outcomes
- Progression Free Survival 2 (PFS2)(Up to 6 years)
- Number of Participants With Adverse Events (AEs)(From first dose to 30 days post last dose (up to 9 years))