E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory follicular NHL |
Linfoma Non Hodgin follicolare recidivante o refrattario al trattamento |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016905 |
E.1.2 | Term | Follicle centre lymphoma, follicular grade I, II, III recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for the treatment of subjects with relapsed or refractory, follicular NHL. |
Confrontare i benefici clinici di galiximab in associazione a rituximab con quelli della monoterapia di rituximab per il trattamento di soggetti con LNH follicolare recidivante o refrattario al trattamento |
|
E.2.2 | Secondary objectives of the trial |
· To further characterize the safety profile of galiximab in combination with rituximab. · To further characterize the pharmacokinetics (PK) of 4 infusions of galiximab in combination with rituximab. |
- caratterizzare ulteriormente il profilo di sicurezza di galiximab in associazione con rituximab- caratterizzare ulteriormente la farmacocinetica di 4 infusioni di galiximab in associazione con rituximab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Must give written informed consent and any authorizations as required by local law (e.g., Protected Health Information [PHI] for North America) 2. Aged ³ 18 years old at the time of informed consent 3. Histologically confirmed follicular NHL Grade 1-3a (if the subject has received any intervening lymphoma therapy since the most recent biopsy, a repeat biopsy will be required to exclude transformation) 4. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following: · Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in Appendix C on the protocol · The presence of B symptoms · Bulky disease (at least 1 lesion >5 cm) · Laboratory abnormalities (cytopenias or elevated LDH) · Presence of masses which are causing ongoing clinical symptoms 5. Bidimensionally measurable disease with at least 1 lesion ³ 2.0 cm in a single dimension 6. Hematologic, hepatic, and renal function parameters satisfying the following: · Bilirubin £ 2.0 mg/dL · AST (SGOT) £ 2 ´ upper limit of normal (ULN) and ALT (SGPT) £ 2 ´ ULN · Serum creatinine £ 2.0 mg/dL · Hemoglobin ³ 8.0 g/dL · Absolute neutrophil count ³ 1500 cells/mm3 · Platelet count ³ 75,000 plts/mm3 7. WHO Performance Status £ 2 8. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs 9. Expected survival of ³ 3 months 10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment. |
- Consenso informato firmato - aver compiuto 18 anni al momento della firma del consenso informato - LNH follicolare di grado 1-3a confermato istologicamente |
|
E.4 | Principal exclusion criteria |
1. Follicular lymphoma Grade 3b 2. Previous exposure to galiximab or any anti CD80 antibody 3. Known hypersensitivity to murine proteins 4. Rituximab refractory or refractory to anti CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months) 5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C) 6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1 7. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1 8. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1 9. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1 10. Prior allogeneic transplant 11. Transfusion-dependent subjects 12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.) 13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma, mucosa associated lymphoid tissue (MALT) 14. Presence of central nervous system (CNS) lymphoma 15. Known history of HIV infection or AIDS 16. Prior diagnosis of aggressive NHL or mantle cell lymphoma 17. Histologic transformation 18. Presence of pleural or peritoneal effusion with positive cytology for lymphoma 19. Another primary malignancy requiring active treatment (except hormonal therapy) 20. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor 21. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1 22. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 23. History of alcoholism or substance abuse within the 2 years prior to Study Day 1 24. Pregnant or currently breastfeeding |
- Linfoma follicolare di grado 3b - pecedente esposizinone a galiximab o anticorpi anti CD80 - ipersensibilita` nota alle proteine muriniche - refrattario a rituximab o ad anticorpi anti CD20 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival |
Sopravvivenza libera da progressione |
|
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 16 |
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 | 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
|
Il follow up dopo i primi 4 anni continuera' in uno stusdio separato dal presente, fino a morte del paziente, perdita del follow up o ritiro del Consenso informato |
|
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 |