E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Refractory or relapsed chronic lymphocytic leukemia (CLL) |
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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 | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
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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 |
To evaluate the safety of the combination of lenalidomide and alemtuzumab in subjects with relapsed or refractory CLL. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of the combination of lenalidomide and alemtuzumab in subjects with relapsed or refractory CLL. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Understand and voluntarily sign an informed consent form. 2. Age >=18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Diagnosed with CLL and failed chemotherapy for CLL defined as refractory or relapsed with new need of treatment within 12 months after chemotherapeutic regimens in use for CLL therapy. 5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to first treatment dose in this study. 6. ECOG performance status of <= 2 at study entry (see Appendix 1). 7. Laboratory test results within these ranges: - Absolute neutrophil count >=0.5 x 109/L - Platelet count >=25 x 109/L - Serum creatinine 177 µmol/L - Total bilirubin 26 µmol/L - ASAT (SGOT) and ALAT (SGPT) <= 2 x ULN or <= 5 x ULN unless attributable to CLL 8. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast. 9. Able to take aspirin (75 or 160 mg) daily as prophylactic anticoagulation, unless patients intolerant to ASA may use low molecular weight heparin. If platelet count < 50 x 109/L, prophylactic anticoagulation should not be given. 10. 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
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E.4 | Principal exclusion criteria |
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Use of any other experimental therapy within 28 days of baseline. 5. Any prior use of lenalidomide or thalidomide. 6. Concurrent use of other anti-cancer agents or treatments. 7. Known positive for HIV or infectious hepatitis, type A, B or C. 8. Opportunistic infections within the last 4 months. 9. Previous alemtuzumab therapy within the last 4 months. 10. Renal impairment, defined as calculated creatinine clearance below 60mL/min as defined by the method of Cockroft-Gault. 11. Evidence of pre-existing TLS per the Cairo-Bishop definition of laboratory TLS(Subjects may be enrolled upon correction of electrolyte abnormalities). 12. History of renal failure requiring dialysis. 13. Uncontrolled hemolytic anemia or autoimmune thrombocytopenia.
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the safety (type, frequency, and severity) of adverse events (AEs) and relationship of AEs to lenalidomide and alemtuzumab treatment. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
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) | Yes |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |