| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| •Relapsed or refractory T-cell non Hodgkin's lymphoma |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | HLGT |
| E.1.2 | Classification code | 10018865 |
| E.1.2 | Term | Haematopoietic neoplasms (excl leukaemias and lymphomas) |
|
| 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 determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell NHL. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. |
|
| E.2.2 | Secondary objectives of the trial |
| •To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Must understand and voluntarily sign an informed consent form.
•Must be ≥ 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 T-cell non-Hodgkin’s lymphoma, either:
-PTCL whatever the subtype, or
-CTCL, but only the subtype mycosis fungoides.
•Relapsed or refractory to previous therapy for T-cell NHL.
•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.
•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 ≥ 90 days (3 months).
•FCBP must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study and for at least 28 days after discontinuation from the study. FCBP must agree to pregnancy testing and contraceptive counseling every 28 days during the study. FCBP must also refrain from donating blood while participating in the study and for at least 28 days after discontinuation from this study.
•Males must agree to use a latex condom during any sexual contact with FCBP while participating in this study and for at least 28 days following discontinuation from this study even if he has undergone a successful vasectomy. Males must also agree to refrain from donating blood, semen, or sperm while participating in this study and for at least 28 days after discontinuation from this study.
•Subjects must agree to not share study drug with anyone during participation in the study.
|
|
| E.4 | Principal exclusion criteria |
•TCL of subtype Sézary syndrome.
•Any of the following laboratory abnormalities.
-Absolute neutrophil count (ANC) < 1,500 cells/mm3(1.5 x 10 9/L).
-Platelet count < 60,000/mm3 (60 x 10 9/L).
-Serum asparate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 5.0 x upper limit of normal (ULN).
-Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL, except in case of hemolytic anemia.
•Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min.
•Candidates for and willing to undergo an autologous stem cell transplant.
•Subjects who are post allogenic stem cell transplant.
•Active CNS lymphoma with the exception of those subjects whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT or MRI are eligible. If required, lumbar puncture, CT or MRI should be performed during the screening process. Subjects should not be receiving corticosteroids.
•Prior history of malignancies other than T-cell lymphoma (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 ≥ 2 years.
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Known positive for Human Immunodeficiency Virus (HIV).
•Pregnant or lactating females.
•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 180 days (6 months).
-Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
•Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
•Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
•Subjects with ≥ 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. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| 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 | Yes |
| 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) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| 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 | 24 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| 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 | 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 |
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