For the treatment of relapsed or refractory B-CLL. MedDRA version: 8.1 Level: LLT Classification code 10003946 Term: B-Lymphocytic, CLL (Kiel Classification)
Conditions
Interventions
Trade Name: Revlimid
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lenalidomide
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Other descri
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must understand and voluntarily sign an informed consent form. Must be =18 years of age at the time of signing the informed consent form. Must be able to adhere to the study visit schedule and other protocol requirements. Must have a documented diagnosis of B-cell CLL (NCI-WG criteria, Appendix 21.4) that has relapsed after or is refractory to at least one prior regimen. The prior treatment regimen(s) must have included: - An alkylating agent (e.g., chlorambucil or cyclophosphamide) and; - Fludarabine (subjects must have developed disease progression within 12 months (of the completion of the last treatment cycle) of their most recent fludarabine-containing regimen). Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of = 2. Females of childbearing potential (FCBP) - Have a negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy (see specifics in Appendix 21.6). This applies even if the subject practices complete and continued sexual abstinence. - Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy (see specifics in Appendix 21.6). Male subjects must: - Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy (See specifics in Appendix 21.6). - Agree to not donate semen or sperm during study drug therapy and for a period after end of study drug therapy (see specifics in Appendix 21.6). All subjects must: - Have an understanding that the study drug could have a potential teratogenic risk. - Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy (see specifics in Appendix 21.6). - Agree not to share study medication with another person. - All subjects must be counseled about pregnancy precautions and risks of fetal exposure (See Appendix 21.6 of the protocol). 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
Exclusion criteria
Exclusion criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or lactating females. Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment. Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging and subjects with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within two weeks prior to randomization. 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. History of renal failure requiring dialysis Known HIV-1 positivity. Prior therapy with lenalidomide. Alemtuzumab therapy with lenalidomide treatment Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (Appendix 21.6)(subjects may be enrolled upon correctionof electrolyte aabnormalities) Any of the following laboratory abnormalities: - ANC 3.0 x upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL Prior allergic reaction to thalidomide. Prior desquamating (blistering) rash while taking thalidomide. = Grade-2 neuropathy. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. Richter’s Transformation (active) Participation in and clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy Known presence of alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: To evaluate the safety of lenalidomide when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) Phase 2: To evaluate the safety of lenalidomide administered by continuous daily regimen versus that of lenalidomide administered by a cyclic regimen in subjects with relapsed or refractory B-cell CLL.;Secondary Objective: Phase 1: To evaluate the efficacy of a stepwise dose-escalation schedule of lenalidomede in subjects with relapsed or refractory B-cell CLL. Phase 2: To evaluate the efficacy of lenalidomide administered by continuous daily regimen versus that of lenalidomide administerd by cyclic regimen in subjects with relapsed or refractory B-cell CLL.;Primary end point(s): Safety (type, frequency and severityof adverse events and laboratory abnormalities and the relationship of As to lenalidomide) | — |
Countries
France, Italy, Sweden, United Kingdom
Outcome results
None listed