E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with refractory and recidivated primary CNS lymphoma |
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MedDRA Classification |
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 |
The objective of this study is to assess efficacy of Temsirolimus in patients with refractory and recidivated primary CNS lymphoma |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions - Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate - ECOG performance score ≤ 2 - Age ≥18 and ≤ 75 years - Life expectancy of at least 3 months - Absence of active infection - Negative HIV serology - Adequate renal function (GFR >30ml/min) - Adequate bone marrow resere (neutrophils > 1500/µl, platelets > 80,000/µl) - Bilirubin <1.5x upper limit of normal (ULN), ALT and AST <3x ULN - At least 3 weeks interval from prior cytostatic treatment - Negative pregnancy test - Patient accessible for treatment and follow-up - Patient compliance - Signed written informed consent (AMG §40 (1) 3b)
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E.4 | Principal exclusion criteria |
- Secundary CNS lymphoma - Primary intraocular lymphoma - Concurrent treatment within another clinical trial - Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation - Concurrent other malignant disease - Symptomatic congestive heart failure (≥NYHA II) - Active or uncontrolled chronic infection - Severe concomitant disease incompatible with study conduct - History of cerebral bleeding - Concomitant treatment with strong CYP3A4/5-inductors or –inhibitors - Premenopausal women without highly effective contraception (defined as Pearl index <1) - Pregnant or lactating women - Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol - Subjects who are legally detained in an official institute |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate (partial or complete remission) |
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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 | No |
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 | Yes |
E.7.1.3.1 | Other trial type description |
Phase II, double-stage design (according to Simon) |
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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 | Yes |
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
| Yes |
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 | 1 |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |