E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with relapsed or refractory mantle cell lymphoma after or not eligible for myeloablative treatment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026800 |
E.1.2 | Term | Mantle cell lymphoma recurrent |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026801 |
E.1.2 | Term | Mantle cell lymphoma refractory |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
the primary objective ist to evaluate feasibility of lenalidomide maintenance |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are the assessment of efficacy and the toxicity profile of lenalidomide maintenance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically confirmed, refractory or relapsed mantle cell lymphoma according to the World Health Organization (WHO) classification 2. Histological material available for reference pathology 3. Relapse or progression following at least one adequate prior line of anti-neoplastic therapy 4. Complete or partial remission after salvage induction of 3-4 courses R-FC(M), R-B(M), or 4-6 cycles R- CHOP 5. Prior high-dose chemotherapy treatment with autologous stem cell transplantation (at least 6 months ago) or not eligible for a high dose approach 6. Age >= 18 years at the time of signing the informed consent form 7. Written informed consent 8. ECOG performance status of <= 2 at study entry (see Appendix I) 9. Able to adhere to the study visit schedule and other protocol requirements 10. Laboratory test results within these ranges: • Absolute neutrophil count >=1.5 x 109/L • Platelet count >= 100 x 109/L • Serum Creatinine < 2.0 mg/dL • Total serum bilirubin <= 2.0 mg/dL • AST (SGOT) and ALT (SGPT) <=3 x ULN 11. Female subjects of childbearing† potential must: o Understand the study drug is expected to have a teratogenic risk o Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception. o She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy o Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment o Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit.. This requirement also applies to women of childbearing potential who practice complete and continued abstinence † Definition: see section 8.1 of trial protocol 12. Male subjects must o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy if their partner is of childbearing potential and has no contraception. o Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. 13. All subjects must o Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. o Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist. 14. Disease free of other malignancies for more than or equal to 3 years with exception of basal cell carcinoma of the skin, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) or cervical cancer in situ 15. Able to take aspirin (100 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin or coumarin, respectively an equivalent vitamine K antagonist. 16. Negative serology for HIV, Hepatitis B and C at most 4 weeks before inclusion |
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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 4. Use of any other experimental drug or therapy within 28 days of begin of maintenance therapy or during study participation 5. Known hypersensitivity to thalidomide 6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs 7. Any prior use of lenalidomide 8. Concurrent use of other anti-cancer agents or treatments 9. Known HIV or active hepatitis infection, type A, B or C 10. Known acute thrombosis 11. CNS involvement of MCL 12. Biologic or immunotherapy (interferon, IL-2, B-cell specific antibodies etc.) less than 4 weeks prior to entry on this study or persistent toxic side effects of such therapy 13. Known thrombophilia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility of lenalidomide maintenance determined by the percentage of patients in which lenalidomide maintenance is not stopped prematurely |
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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 | Yes |
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 | No |
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) | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | Yes |
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
|
The end of study is defined as the date of the last visit of the last patient undergoing the study (see chapter 21.9 of protocol) |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |