| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| INDOLENT NON-HODGKIN'S LYMPHOMA |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10029547 |
| E.1.2 | Term | Non-Hodgkin's lymphoma |
| 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 |
| Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years |
|
| E.2.2 | Secondary objectives of the trial |
PFS in the overall study population, investigator-assessed up to approximately 7.5 years
PFS in the overall study population, Independent Review Committee assessed up to approximately 7.5 years
Response (OR and CR) assessed by the investigator up to 168 days
Response (OR and CR) assessed by Independent Review Committee 168 days
OS up to approximately 10.7 years
Event-free survival up to approximately 7.5 years
Disease-free survival up to approximately 7.5 years
Duration of response up to approximately 7.5 years
Time to next anti-lymphoma treatment up to approximately 10.7 years
Incidence of adverse events up to approximately 10.7 years
Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) up to approximately 7.5 years |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: DNA REPOSITORY SUBSTUDY IN ASSOCIATION WITH RO5072759 (GA101) STUDY BO21223 (GALLIUM)
Date and Version: BO21223 (DNA Substudy), Version 1, 16-Jul-2012
Objectives: The primary objective of this study is to perform exploratory analyses to generate hypotheses that will help to identify genetic markers associated with disease diagnosis, treatment response, toxicity, or disease prognostic risk. If such genetic hypotheses are identified and validated, they may be tested in future clinical studies within this therapeutic area. |
|
| E.3 | Principal inclusion criteria |
- Adult patients, >/= 18 years of age
- CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
- Stage III or IV disease, or Stage II bulky disease
- At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Adequate hematologic function" |
|
| E.4 | Principal exclusion criteria |
- Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
- Ann Arbor Stage I disease
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
- For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
- For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
- History of other prior malignancy with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or cacinoma in situ of the cervix at any time prior to the study. Other cancers not specified above wich have been curatively treated by surgary alone and from which the subject is disease-free for ≥5years without further treatment
- Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
- Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
- Patients with a history of confirmed PML |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy endpoint, PFS in patients with follicular lymphoma, is defined as the time from randomization to the first occurrence of progression or relapse as assessed by the investigator according to the Revised Response Criteria for Malignant Lymphoma and additional response criteria for MZL (Cheson et al. 2007), or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment, or if no tumor assessments were performed after the baseline visit, at the time of randomization. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| up to approximately 7.5 years |
|
| E.5.2 | Secondary end point(s) |
Progression-free survival in the overall study population, investigator-assessed
Progression-free survival, Independent Review Committee - assessed
Response (overall response and complete response), investigator-assessed
Response (overall response and complete response), Independent Review Committee - assessed
Overall survival
Event-free survival
Disease-free survival
Duration of response
Time to next anti-lymphoma treatment
Safety: Incidence of adverse events
Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
84 days for induction
168 day for Response
7.5 to 10.7 years for all other end points |
|
| 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 | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Self Assessed Quality of Life |
|
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 175 |
| 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 |
| Argentina |
| Australia |
| Bosnia and Herzegovina |
| Brazil |
| Canada |
| Chile |
| China |
| Colombia |
| El Salvador |
| Guatemala |
| Ireland |
| Japan |
| Macedonia, the former Yugoslav Republic of |
| Mexico |
| Panama |
| Peru |
| Russian Federation |
| South Africa |
| Taiwan |
| Ukraine |
| United States |
|
| 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
|
| The date of the last follow-up visit (to occur 5 years after the last study treatment) of the last patient entered, or sooner, if all patients have progressed, died, or withdrawn from the study. With consideration of a recruitment period of approximately 2.5 years, the overall duration of the study is planned to be approximately 10.2 years (or shorter, if all patients have progressed, died, or withdrawn from the study). The Sponsor has the right to terminate the study at any time. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 10 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 10 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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