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) - Full Text View

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00774345

Purpose

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.

Condition	Intervention	Phase
B-cell Chronic Lymphocytic Leukemia	Drug: Lenalidomide Drug: Placebo	Phase 3

Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

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:	400
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2018
Estimated Primary Completion Date:	August 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Lenalidomide po qd on days 1-28 of a 28 day cycle	Drug: Lenalidomide 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	Drug: Placebo Placebo capsules given orally on days 1 - 28 of a 28 day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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- 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

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774345

Contacts

Contact: Duong Nguyen, PharmD., RPh

908-673-9803

dnguyen@celgene.com

Show 216 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Jay Mei, MD

Celgene Corporation

More Information

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00774345 History of Changes
Other Study ID Numbers:	CC-5013-CLL-002
Study First Received:	October 16, 2008
Last Updated:	May 22, 2012
Health Authority:	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 - French Health Products Safety Agency 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 and Social Development 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:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012