A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell CLL Following Second Line Therapy - Full Text View

Sponsored by:	Celgene Corporation
Information provided by:	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 III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	680
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator	Drug: Placebo

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-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

Contacts and Locations

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

Contacts

Contact: Marcia Rios, MBA

908-673-9267

Locations

United States, California
Pacific Coast Hematology	Recruiting
Fountain Valley, California, United States, 92708
Contact: Barbara Lepthien 714-845-0300

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Elyane Lombardy, MD

Celgene Corporation

More Information

Responsible Party:	Celgene Corporation ( Elyane Lombardy MD )
Study ID Numbers:	CC-5013-CLL-002
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00774345
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lenalidomide
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009