E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Previously untreated CD20-positive Diffuse Large B-Cell Lymphoma (DLBCL) patients who have low-intermediate, high-intermediate, or high-risk disease according to the IPI score and patients with bulky tumor (largest diameter ≥ 7.5 cm) regardless of disease risk according to the IPI. | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10012818 | E.1.2 | Term | Diffuse large B-cell lymphoma | |
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 follow-up safety in previously untreated patients with diffuse large B cell lymphoma (DLBCL) with at least low-intermediate risk disease according to the IPI or bulky disease regardless of IPI risk category who were enrolled into the BO20603 study and treated with rituximab and CHOP (R-CHOP) alone versus patients treated with any cycle of bevacizumab in combination with rituximab and CHOP (RA-CHOP). | |
E.2.2 | Secondary objectives of the trial | Secondary objectives: not applicable Exploratory objectives: • To identify prognostic biomarkers for response to treatment • To identify predictive biomarkers for safety | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | • Patients previously randomized to the BO20603 study (MAIN) and who have received any cycle of study treatment prior to termination of bevacizumab treatment by 31 May 2010. • Previously randomized patients providing written informed consent to continue study participation according to this modified version of the study protocol (version D). | |
E.4 | Principal exclusion criteria | • Patients not randomized to the BO20603 study prior to 01 June 2010 following the DSMB recommendation which became effective on 31 May 2010. • Previously randomized patients who are not willing to sign the amended informed consent. | |
E.5 End points |
E.5.1 | Primary end point(s) | To follow-up safety in patients treated with R-CHOP versus patients treated with any cycle of bevacizumab in combination with rituximab and CHOP (RA-CHOP) in previously untreated patients with diffuse large B cell lymphoma (DLBCL) with at least low-intermediate risk disease according to the IPI or bulky disease regardless of IPI risk category. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description | Follow-up and Biomarker analysis | |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | |
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 End of the study is defined as the date of the last follow-up visit (12 months after last R-CHOP treatment cycle during the induction treatment phase) of the last patient randomized. Study end might occur earlier if all patients have progressed, died or withdrawn from the study. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |