E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed / Refractory Mantle Cell Lymphoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10026800 |
E.1.2 | Term | Mantle cell lymphoma recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To evaluate the rates of overall response to lenalidomide in terms of complete response, complete response unconfirmed and partial response |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the duration of response To determine the median time to progression To determine the median overall survival To evaluate the toxicity and tolerability of the research treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients 18 years and older A confirmed mantle cell lymphoma which is refractory to, or relapsed following the completion of 2 or more anti-neoplastic therapies - All chemotherapy regimens are permissible Measrable disease Karnofsky Performance Status >/= 50% (ECOG 0-2) Absolute neutrophil count of >/= 1000 cells/uL, not related to lymphoma Platelets >/= 30,000 cells/uL Aspartate transaminase </=3 x upper limit of normal, alanine transaminase </=3 x upper limit of normal, total bilirubin </= 2x upper limit of normal Toxic effects of previous therapy or surgery resolved to grade 2 or better Female patients who are either post-menopausal, sugically sterilised or willing to use 2 acceptable methods of birth control Male patients who agree to use an acceptable method of birth control for the duration of the study Patients who have given written informed consent, prior to any study related proceedures |
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E.4 | Principal exclusion criteria |
Patients known to be serologically positive for HBV, HCV or HIV Previous treatment with lenalidomide Any anti-neoplastic therapy within 3 weeks prior to Day 1 of Cycle 1 Any nitrosoureas within 6 weeks prior to Day 1 of Cycle 1 Treatment with Rituximab, Alemtuzumab or other unconjugated therapeutic antibody within 4 weeks prior to Day 1 of Cycle 1 Radiation therapy within 3 weeks before Day 1 of Cycle 1 Major surgery within 2 weeks prior to Day 1 of Cycle 1 Active systemic infection requiring treatment Any concurrent active malignancy female patients who may be pregnant or breast-feeding Serious medical or psychiatric illness likely to interfere with participation in this study Concurrent treatment with another investigational agent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Disease progression Unacceptable toxicity or tolerability Patients withdarawl of consent |
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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 | 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
| 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 | 4 |
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 | 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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |