E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Hodgkin peripheral T-cell lymphomas |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10034623 |
|
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 evaluate the efficacy ie complete clinical response at one year of an intensified chemo-immunotherapy program in patients with PTCL |
|
E.2.2 | Secondary objectives of the trial |
Overall survival Disease free-survival Treatment related mortality |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Age 18 and 60 years for Study A patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures and 60 and 75 years for Study B patients older than 75 years are excluded because of the intensive chemo-immunotherapy program Histologically proven diagnosis of PTCL, including the following categories PTCL-U peripheral T-cell lymphoma, unspecified , AILD-T angioimmunoblastic-like T-cell lymphoma , ALKneg ALCL ALK-negative anaplastic large cell lymphoma ,intestinal T - NHL Advanced stage disease stage II-IV or stage I and aaIPI score 2 Written informed consent CD52 expression on neoplastic cells |
|
E.4 | Principal exclusion criteria |
Histological PTCL subset other than PTCL-U, AILD-T, ALKneg-ALCL, intestinal T - NHL Central nervous system localization Positive serologic markers for human immunodeficiency virus HIV , hepatitis B virus HBV , and hepatitis C virus HCV infection Serum bilirubin levels 2 the upper normal limit Clearance of creatinine 50 ml/min DLCO 50 Ejection fraction 45 or myocardial infarction in the last 12 months Pregnancy or lactation Patient not agreeing to take adequate contraceptive measures during the study Psychiatric disease Any active, uncontrolled infection Type I hypersensivity or anaphylactic reactions to proteins drugs Active secondary malignancy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of innovative therapies in non Hodgkin peripheral T-cell lymphomas |
|
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
due studi di fase II per classi di eta diverse |
|
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 | Information not present in EudraCT |
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.8.5 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |