A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell CLL Following Second Line Therapy (THE CONTINUUM TRIAL)
Tracking InformationStart Date ICMJE | January 2009 |
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Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: August 14, 2009) | - Overall Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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Original Primary Outcome Measures ICMJE (submitted: October 16, 2008) | - Overall Survival [ Time Frame: After 340 events have occured ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: After 340 events have occured ] [ Designated as safety issue: No ]
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Change History | Complete list of historical versions of study NCT00774345 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: August 14, 2009) | - Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Tumor Response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Health Related Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell CLL Following Second Line Therapy (THE CONTINUUM TRIAL) |
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Official Title ICMJE | 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) |
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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. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | B-cell Chronic Lymphocytic Leukemia |
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Intervention ICMJE | |
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Study Arms / Comparison Groups | - 1: Experimental
Lenalidomide po qd on days 1-28 of a 28 day cycle Intervention: Drug: Lenalidomide - 2: Placebo Comparator
Placebo capsules given orally on days 1-28 of a 28 day cycle Intervention: Drug: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 680 |
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Estimated Completion Date | March 2015 |
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Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Must sign an informed consent form.
- Age ≥ 18 years
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of B-cell CLL.
- Must have been treated with a purine analog-containing regimen in the first and/or second line induction therapy.
- Must have achieved a minimum of partial response following completion of second-line induction therapy.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of lenalidomide.
- Must agree not to donate blood, eggs or sperm as defined by the protocol
Exclusion Criteria: - Any medical condition, that would prevent the subject from signing the informed consent form.
- Active infections requiring systemic antibiotics.
- Systemic infection that has not resolved > 2 months prior to initiating lenalidomide
- Autologous or allogeneic bone marrow transplant as second line therapy.
- Pregnant or lactating females.
- Participation in any clinical study or having taken any investigational therapy within 28 days.
- Known presence of alcohol and/or drug abuse.
- Central nervous system (CNS) involvement.
Prior history of malignancies, other than CLL, unless the subject has been free of the disease for ≥3 years. Exceptions include the following: - Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- History of renal failure requiring dialysis.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
- Prior therapy with lenalidomide.
- Presence of specific hematology and/or chemistry abnormalities
- Severe rash due to prior thalidomide treatment
- Uncontrolled hyperthyroidism or hypothyroidism
- Venous thromboembolism within one year
- ≥ Grade-2 neuropathy
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | United States, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00774345 |
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Responsible Party | Elyane Lombardy MD, Celgene Corporation |
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Study ID Numbers ICMJE | CC-5013-CLL-002 |
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Study Sponsor ICMJE | Celgene Corporation |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Elyane Lombardy, MD | Celgene Corporation | |
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Information Provided By | Celgene Corporation |
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