E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients 18 - 65 years old with newly diagnosed non-cutanous, non leukemic Peripheral T- cell lymphoma, except alk-protein positive anaplastic large cell 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 | 10042971 |
E.1.2 | Term | T-cell 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 |
To assess the effect of the addition af Mab Campath s.c. to 2 Weekly CHOP 14 ( Chemotherapy) in terms of event free survival (EVS). |
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E.2.2 | Secondary objectives of the trial |
¨ To assess the effect of the addition of alemtuzumab s.c. to 6 courses of 2-weekly CHOP14 in term of overall survival (OS), progression-free survival (PFS) and overall response rates (ORR, i.e. CR/CRu/PR). Assessment of ORR means evaluating eligibility to autologous stem cell transplantation. ¨ To evaluate the safety of the addition of alemtuzumab s.c. combined with 2-weekly CHOP with respect to the incidence of severe opportunistic infections and infections due to neutropenia as well as the adherence to protocol as defined in To assess the overall response rate (ORR) related to CD52 expression |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
9.1.1 Inclusion criteria ¨ Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (≥ 7.5 cm) and stages II to IV. ¨ Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C): ü Peripheral T-cell lymphoma, unspecified (PTCL NOS) ü Angioimmunoblastic T-cell lymphoma ü Enteropathy-type T cell lyphoma ü Primary systemic, alk-negative anaplastic large cell lymphoma (T- or null phenotype) ü Subcutaneous panniculitis-like T-NHL ü Hepatosplenic gd T-cell lymphoma ü Extranodal NK/T cell lymphoma, nasal type ¨ Age 18-65 years at time or randomization ¨ Life expectancy of 3 months or longer ¨ WHO performance status (PS) 0, 1 or 2 at the time of randomization (see appendix D). However, PS 3 will be acceptable if lymphoma-related. ¨ Measurable disease ¨ Written informed consent
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E.4 | Principal exclusion criteria |
¨ Patients with NK/T-NHL of the following type: ü Precursor T cell lymphoblastic lymphoma/leukemia ü All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL) ü Alk-positive anaplastic large cell lymphoma ü Blastic NK cell lymphoma ¨ Known hypersensitivity to murine or chimeric antibodies or proteins ¨ Severe cardiac dysfunction (NYHA classification II-IV, Appendix H) or LVEF < 45 % ¨ Significant renal dysfunction (serum creatinin > 2 times upper level), unless related to NHL ¨ Significant hepatic dysfunction (total bilirubin ³ 30 mmol/l or transaminases ³ 2.5 times normal level), unless related to NHL ¨ Suspected or documented Central Nervous System involvement by NHL ¨ Patients known to be HIV-positive ¨ Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg ¨ Patients with uncontrolled asthma or allergy, requiring steroid treatment ¨ Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type ¨ History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma ¨ Unwillingness or inability to comply with the protocol ¨ Simultaneous participation in any other study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the Event-free Survival (EFS). The EFS is defined by the time between day of randomization until one of the following events occurs, whichever comes first: · Disease progression during therapy · Institution of any additional unplanned anti-tumor treatment · Relapse after achievement of CR/CRu · Death due to any cause Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
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 | 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
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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 | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |