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
This study is currently recruiting participants.
Verified January 2013 by Celgene Corporation
Information provided by (Responsible Party):
First received: October 16, 2008
Last updated: April 2, 2013
Last verified: January 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Overall Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
- 240 Events For Progression Free Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Tumor Response [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Health Related Quality of Life [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2018 (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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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- or bendamustine- containing regimen in the first and/or second line induction therapy. Alemtuzumab-containing regimens in place of purine analog- or bendamustine- containing regimens will also be allowed for those patients with 17p deletion.
- 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
- 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.
- Know Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) and/or active 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774345
||Jay Mei, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 16, 2008
||April 2, 2013
||United States: Food and Drug Administration
Canada: Health Canada
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
South Africa: Medicines Control Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents