A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA - CC-5013-CLL-001
- Conditions
- Relapsed or refractory CLL-B in patients previously treated with alkilating agents after failure of fludarabine treatmentMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia
- Registration Number
- EUCTR2006-004469-32-IT
- Lead Sponsor
- CELGENE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
1. Must understand and voluntarily sign an informed consent form. 2. Age > 18 years at the time of signing the informed consent form. 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 (NCI-WG criteria) that has relapsed after or is refractory to at least one prior regimen. The prior treatment regimen(s) must have included: a. An alkylating agent (e.g., chlorambucil or cyclophosphamide) and; b. Fludarabine (subjects must have failed to achieve at least a partial response lasting for 12 months (after completion of the last treatment cycle) to their most recent fludarabine-containing regimen). 5. Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of * 2. 6. Females of childbearing potential (FCBP)? must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner?s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or lactating females. 3. Systemic treatment for B-cell CLL within 28 days of randomization. 4. Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging; subjects with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks prior to randomization. 5. Prior history of malignancy other than CLL (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for 3 years. 6. Known HIV-1 positivity. 7. Prior therapy with lenalidomide. 8. Any of the following laboratory abnormalities: (a) ANC < 500/μL (0.5 X 109/L) (b) Platelet count < 25,000/μL (25 x 109/L) (c) Serum creatinine > 2.5 mg/dL (d) Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) (d) Serum total bilirubin > 2.0 mg/dL 9. Prior allergic reaction to thalidomide. 10. Prior desquamating (blistering) rash while taking thalidomide. 11. Peripheral neuropathy grade 2. 12. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. 13. Richter?s transformation (active).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of two dose regimens of lenalidomide in subjects with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL);Secondary Objective: To evaluate the safety of two dose regimens of lenalidomide in subjects with relapsed or refractory B-cell CLL;Primary end point(s): Response
- Secondary Outcome Measures
Name Time Method