E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PERIPHERAL T-CELL LYMPHOMA PTCL EXPRESSING PDGFRA |
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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 | 10025310 |
E.1.2 | Term | Lymphoma |
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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 |
- Assessment of safety and tolerability of imatinib mesylate 400 mg bid in the clinical setting of peripheral T-cell lymphomas PTCL ; - Assessment of clinical responses defined as disease stabilization DS , partial remission PR , and complete remission CR . |
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E.2.2 | Secondary objectives of the trial |
- Assessment of the response duration in terms of progression free survival PFS - Assessment of the response duration in terms of overall survival OS |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Diagnosis of PTCL expressing PDGFRA, in patients who - have relapsed or are refractory to conventional therapy, - are, for whatever reason, not considered candidates for other alternative therapy. 2. Age 18 years or greater. 3. ECOG Performance score of 0, 1, 2 or 3 Karnofsky Performance Score 40 . 4. Life expectancy 4 weeks. 5. Adequate hepatic and renal function, as defined by serum transaminases 2.5x ULN,bilirubin 1.5x ULN, and creatinine 1.5x ULN. 6. Post-menopausal, surgically sterile, or taking effective contraception in female patients. 7. Documentation of written informed consent to participate in the trial. 8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. |
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E.4 | Principal exclusion criteria |
1. Treatment with any investigational agent within 3 weeks prior to study therapy. 2. Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to a. Presence of central nervous system CNS lymphoma. b. Active uncontrolled bacterial infection. c. Known human immunodeficiency virus HIV infection. d. Grade 4 bleeding. e. Significant cardiovascular disease i.e., uncontrolled arrhythmias, unstable angina , or a major thromboembolic event myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis in the last 6 months. f. Patients with known adrenal insufficiency. g. Pregnancy or breast-feeding. h. Malabsorption syndromes ecc. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The primary end-point is the rate of clinical response partial and complete responses PR and CR in all patients. |
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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
| 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 | 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
| |
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 |