Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia, [Hallek M et al, 2008]). MedDRA version: 9.1 Level: LLT Classification code 10008956 Term: Chronic lymphatic leukaemia
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Tablet
INN or Proposed INN: Lenalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must understand and voluntarily sign an informed consent form. Must be ≥ 18 years 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 (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia, [Hallek M et al, 2008]). Rai stage III or IV disease or requiring treatment for Rai stage I or II disease as defined in the Updated National Cancer Institute (NCI) guidelines (Hallek M et al, 2008). See Appendix B. Patients must have received at least a purine-analogue containing regimen and have experienced relapse or have been refractory to the last therapy. Patients must not have received any therapy for B-CLL in the 4 weeks before this study or Alemtuzumab in the 6 months before initiating the treatment of this study. Eastern Cooperative Oncology Group performance status of ≤ 2. Absolute neutrophil count ≥ 2.000/μL Platelet count ≥ 75/μL Calculated creatinine clearance > 60 mL/min and creatinine 2 mg/dl if Gilbert ?s Sindrome). ALT and AST =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any serious medical condition, laboratory anormality or psychiatric illness that would prevent the subject from signing the informed consent form. Active infections requiring systemic antibiotics. Known positive for HIV or active infectious hepatitis. Active bacterial, viral, or fungal infection requiring systemic anti-viral, antibiotic or antifungal therapy. Autologous or allogenic bone marrow transplant as second line therapy. Pregnant or lactating females. Patients must not have received any therapy for B-CLL in the 4 weeks before or Alemtuzumab 6 months before initiating the treatment of this study. History of renal failure requiring dialysis. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. Severe cardiac, pulmonary, renal or hepatic concomitant disease or clinical laboratory finding giving reasonable suspicious of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications. Disease transformation (active) (i.e. Richter?s Syndrome, prolymphocytic leukemia). Active secondary malignancy or history of malignant disease within the preceding 5 years with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or the breast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary exploratory objective of this study is to identify clinical, hematological or molecular parameters able to predict response to lenalidomide treatment in relapsed/refractory CLL patients.;Secondary Objective: Secondary objectives of the study include: Identification of predictive factors for early relapse or severe toxicity after lenalidomide treatment in relapsed/refractory CLL. Evaluation of anti tumor activity, clinical efficacy and safety of an accelerated dose escalation procedure for lenalidomide treatment in patients with relapsed/refractory CLL. Identification of predictive markers for Tumor Flare Reaction (TFR) or Tumor Lysis Syndrome and of mechanisms leading to TFR.;Primary end point(s): The primary endpoint is the Overall Response Rate. | — |
Countries
Italy
Outcome results
None listed