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 and negative anaplastic large cell lymphoma. |
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E.1.1.1 | Medical condition in easily understood language |
Lymphoid cancer of T-cell type |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042971 |
E.1.2 | Term | T-cell lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 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
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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): Peripheral T-cell lymphoma, unspecified (PTCL NOS), Angioimmunoblastic T-cell lymphoma, Enteropathy associated T cell lymphoma, Subcutaneous panniculitis-like T-NHL, Hepatosplenic gd T-cell lymphoma, 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 types are excluded: Precursor T cell lymphoblastic lymphoma/leukemia, All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL), Alk-positive and negative anaplastic large cell lymphoma, 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
- Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmoanry function test shows FEV1<50% or a diffusion capacity <50% of the reference values
- 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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
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 | No |
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 | 8 |
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 | 8 |