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)

Location:

Jacksonville, Fla.

Trial status:
Open for Enrollment
Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria:

         1. Must sign an informed consent form.

         2. Age ≥ 18 years

         3. Must be able to adhere to the study visit schedule and other protocol requirements.

         4. Must have a documented diagnosis of B-cell CLL.

         5. 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.

         6. Must have achieved a minimum of partial response following completion of second-line induction therapy.

         7. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.

         8. Must agree to follow pregnancy precautions as required by the protocol.

         9. Must agree to receive counseling related to teratogenic and other risks of lenalidomide.

        10. Must agree not to donate blood, eggs or sperm as defined by the protocol

       Exclusion Criteria:

         1. Any medical condition, that would prevent the subject from signing the informed consent form.

         2. Active infections requiring systemic antibiotics.

         3. Systemic infection that has not resolved > 2 months prior to initiating lenalidomide

         4. Autologous or allogeneic bone marrow transplant as second line therapy.

         5. Pregnant or lactating females.

         6. Participation in any clinical study or having taken any investigational therapy within 28 days.

         7. Known presence of alcohol and/or drug abuse.

         8. Central nervous system (CNS) involvement.

         9. 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)

        10. History of renal failure requiring dialysis.

        11. Know Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) and/or active Hepatitis C Virus (HCV) infection.

        12. Prior therapy with lenalidomide.

        13. Presence of specific hematology and/or chemistry abnormalities

        14. Severe rash due to prior thalidomide treatment

        15. Uncontrolled hyperthyroidism or hypothyroidism

        16. Venous thromboembolism within one year

        17. ≥ Grade-2 neuropathy

        18. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

Last updated:
2/3/2012
NCT ID:
NCT00774345
IRB Number:
08-007040 13-000616