E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Follicular Limphoma |
Linfoma Follicolare |
|
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 | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10025320 |
E.1.2 | Term | Lymphomas non-Hodgkin's B-cell |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
|
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 determine the efficacy of HuMax-CD20 in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy. |
Determinare l`efficacia di HuMax in pazienti che siano refrattari a rituximab in combinazione con la chemioterapia. |
|
E.2.2 | Secondary objectives of the trial |
To determine the long-term efficacy, the safety and the pharmacokinetic profile in two dose regimens of HuMax-CD20. |
Determinare l`efficacia a lungo termine,la sicurezza e il profilo farmacocinetico nei due livelli di dose di HuMax-CD20 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The trial population will be comprised of patient with a diagnosis of Follicular Lymphoma grade 1 - 2 refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment. Follicular Lymphoma grade 1 - 2 is defined according to WHO guidelines (3) and is verified to be CD20+ positive from excisional lymph node biopsy. Refractory to rituximab in combination with chemotherapy (e.g. R-F, R-CVP, R-CHOP, R-FM, R-FCM), or to rituximab given as maintenance treatment, is defined as: 1. failure to achieve at least PR to rituximab in combination with chemotherapy; or, 2. disease progression while on rituximab (either in combination with chemotherapy or during rituximab maintenance treatment); or, 3. disease progression in responders within 6 months of the last dose of rituximab (either in combination with chemotherapy or after rituximab maintenance treatment schedule) The patients should be `¥ 18 years of age and have given informed consent. |
La popolazione in studio sara` costituta da pazienti con diagnosi di Linfoma Follicolare di grado I-II refrattari a rituximab in combinazione con la chemioterapia o a rituximab somministrato come terapia di mantenimento. Il Linfoma Follicolare di grado I-II e` definito in accordo alle linee guida WHO e viene confermato tramite biopsia del linfonodo per la positivita` CD20+. La refrattarieta` a rituximab in combinazione con la chemioterapia (per es: R-F, R-CVP, R-CHOP-R-FM, R-FCM), o a rituximab somministrato come terapia di mantenimento, e` definita come: 1. Mancato raggiungimento di remissione parziale (PR) dopo rituximab in combinazione con chemioterapia; oppure, 2. Progressione di malattia mentre in trattamento con rituximab (in combinazione con la chemioterapia o durante una terapia di mantenimento con rituximab); oppure, 3. Progressione di malattia nei pazienti `responders` entro 6 mesi dall`ultima dose di rituximab (in combinazione con la chemioterapia oppure dopo una terapia di mantenimento con rituximab). I pazienti dovranno avere eta` maggiore di 18 anni e aver firmato un modulo di consenso informato. |
|
E.4 | Principal exclusion criteria |
The most important exclusion criteria consist of allogenic stem cell transplantation at any time, autologous stem cell transplantation within 6 months prior to Visit 1, more than 1 previous radio immunotherapy, anticancer therapy or corticosteroid therapy within 4 weeks prior to Visit 1 or known or suspected transformation of the follicular lymphoma to aggressive lymphoma unless new biopsy confirms FL. |
I criteri di esclusione piu' importanti consistono nel trapianto di cellule staminali allogeniche in qualsiasi momento, il trapianto di cellule staminali autologhe nei 6 mesi precedenti la visita 1, piu' di una precedente radio-immunoterapia, terapia antitumorale o corticosteroidea entro 4 settimane prima della visita 1, oppure nota o sospetta trasformazione del linfoma follicolare in linfoma aggressivo senza una nuova biopsia che confermi la diagnosi di LF |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Objective response as measured over a 6 month period from start of treatment assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin`s Lymphomas (1;2) |
La risposta obiettiva misurata in un periodo di 6 mesi dall`inizio del trattamento valutata da un Comitato Indipendente di Revisione degli endpoints (IRC), in accordo con i criteri standard di risposta per i Linfomi Non-Hodgkin. |
|
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 | Yes |
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 | No |
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 | 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.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
|
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 | 5 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |