E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refracory aggressive Non-Hodgkin lymphoma |
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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 | 10029547 |
E.1.2 | Term | Non-Hodgkin's lymphoma |
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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 determine the efficacy of lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin s lymphoma. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory aggressive NHL. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Must understand and voluntarily sign an informed consent form. Must be 8805; 18 years of age at the time of signing the informed consent form. Must be able to adhere to the study visit schedule and other protocol requirements. Biopsy-proven aggressive non-Hodgkin s lymphoma. -Follicular center lymphoma Grade 3B. -Diffuse large B-cell lymphoma. -Mantle cell lymphoma. -Transformed lymphoma. Relapsed or refractory to previous therapy for lymphoma. Subjects must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies. Subjects who have relapsed following an autologous stem cell transplant are eligible. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter. Eastern Cooperative Oncology Group ECOG performance status score of 0, 1, or 2. Life expectancy of 8805; 90 days 3 months . Females of childbearing potential 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 |
Any of the following laboratory abnormalities. -Absolute neutrophil count ANC 1,500 cells/mm3 1.5 x 109/L . -Platelet count 75,000/mm3 75 x 109/L . -Serum creatinine 2.5 mg/dL 221 mol/L . -Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal ULN . -Serum total bilirubin 2.0 mg/dL 34 mol/L . Subjects who are candidates for and willing to undergo an autologous stem cell transplant. All subjects with central nervous system CNS disease with the exception of those subjects whose CNS disease has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic, with no active CNS disease, as shown by lumbar puncture, CT scan or MRI, for at least 168 days 6 months as defined by the investigator. Prior history of malignancies other than NHL except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been free of the disease for 8805; 365 days 1 year . Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Known positive for HIV. Pregnant or lactating females. Ejection fraction not within normal institutional limits. Uncontrolled intercurrent illness including, but not limited to -Ongoing or active infection requiring parenteral antibiotics. -Uncontrolled diabetes mellitus as defined by the investigator. -Chronic symptomatic congestive heart failure Class III or IV of the New York Heart Association Classification for Heart Disease . -Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 168 days 6 months . -Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Prior 8805; Grade 3 allergic reaction/hypersensitivity to thalidomide. Prior 8805; Grade 3 rash or any desquamating blistering rash while taking thalidomide. Subjects with 8805; Grade 2 neuropathy. Prior use of lenalidomide. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation Day 1 of study drug therapy. Known active Hepatitis B or C. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the efficacy analyses will be to estimate the response rate in subjects with relapsed or refractory aggressive NHL when treated with lenalidomide |
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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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | |
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 |