E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed, Follicular Non-Hodgkin’s 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 | 10029547 |
E.1.2 | Term | Non-Hodgkin's 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 safety of repeat or initial treatment with galiximab in combination with rituximab after relapse in the pivotal Phase III study (114-NH-301) |
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E.2.2 | Secondary objectives of the trial |
To further characterize the pharmacokinetics (PK) of repeat or initial treatment with galiximab in combination with rituximab To further characterize the efficacy profile of galiximab in combination with rituximab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be considered for registration and randomization into this study, subjects must satisfy all of the following 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. Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 and then relapsed or progressed with a TTP ≥6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC) as described in Appendix C of the protocol 3.Bidimensionally measurable disease with at least 1 lesion ≥2.0 cm in a single dimension 4.Hematologic, hepatic and renal function parameters satisfying the following: a. Bilirubin ≤2.0 mg/dL b. AST (SGOT) ≤2 X upper limit of normal (ULN) and ALT (SGPT) ≤2 X ULN c. Serum creatinine ≤2.0 mg/dL d. Hemoglobin ≥8.0 g/dL e. Absolute neutrophil count ≥1500 cells/mm3 f. Platelet count ≥75,000 plts/mm3 5. WHO Performance Status ≤2 6. Expected survival of ≥3 months 7. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment
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E.4 | Principal exclusion criteria |
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of registration:
1. Any lymphoma therapy between Final Visit on Study 114 NH 301 and Study Day 1 of this retreatment study 2. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1 3. Transfusion-dependent subjects 4. Presence of central nervous system (CNS) lymphoma 5. Histologic transformation 6. Presence of pleural or peritoneal effusion with positive cytology for lymphoma 7. Another primary malignancy requiring active treatment 8. 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 9. New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1 10. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 11. History of alcoholism or substance abuse within the 2 years prior to Study Day 1 12. Pregnant or currently breastfeeding
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoint is Progression-Free Survival (PFS). |
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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 | Yes |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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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Last visit of last subject |
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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 |