E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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]). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008956 |
E.1.2 | Term | Chronic lymphatic leukaemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must understand and voluntarily sign an informed consent form. Must be &#8805; 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 &#8804; 2. Absolute neutrophil count &#8805; 2.000/&#956;L Platelet count &#8805; 75/&#956;L Calculated creatinine clearance > 60 mL/min and creatinine < 1,5 mg/dl. Total bilirubin < 2 mg/dl ( or > 2 mg/dl if Gilbert s Sindrome). ALT and AST < 3x upper normal limit. Female patients of Child-Bearing Potential (FCBP) must have 2 negative medically supervised pregnancy tests prior to starting the drug. They must agree to ongoing pregnancy testing during the course of the study, and after the end of the study therapy. They must adopt reliable methods of contraception and avoid becoming pregnant for at least 28 days after the discontinuation of the study drug. Male patients must agree to use latex condoms during sexual contacts with female of child-bearing potential even if they have had a vasectomy, throughout study drug therapy, during any drug interruption and after cessation of study therapy. They must agree not to donate blood or semen for up to 28 days after study drug discontinuation. |
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E.4 | Principal 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. Richters 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the Overall Response Rate. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
trattamento a dose crescente |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |