A PHASE III, MULTICENTER, OPEN-LABEL, RANDOMIZED TRIAL COMPARING THE EFFICACY OF GA101 (RO5072759) IN COMBINATION WITH CHOP (G-CHOP) VERSUS RITUXIMAB AND CHOP (R-CHOP)IN PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

Not Applicable

• Conditions: -C833 Diffuse large B-cell lymphoma; Diffuse large B-cell lymphoma; C833

• Registration Number: PER-004-13
• Lead Sponsor: F. Hoffmann La Roche Ltd / Genentech Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-14
• Study Completion: 2018-01-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

• * Patients in an IPI disease risk group that is one of the following: high, high-intermediate, or low-intermediate. Patients in the low-risk group are eligible but must have an IPI score of 1,
irrespective of bulky disease or IPI score of 0 with bulky disease, defined as one lesion ≥ 7.5 cm.
• At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan,
• Ability and willingness to comply with the study protocol procedures,
• Age ≥ 18 years,
• ECOG performance status of 0, 1, or 2
• LVEF ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac
echocardiogram,
• Adequate hematologic function.

Exclusion Criteria

• * Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposesother than lymphoma symptom control.
* Primary CNS lymphoma and secondary CNS involvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary
cutaneous DLBCL.
* Vaccination with live vaccines within 28 days prior to randomization.
* Any investigational therapy within 28 days prior to the start of Cycle 1.
* History of other malignancy that could affect compliance with the protocol or interpretation of results.
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease.

* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis.
* abnormal laboratory values.

Study & Design

• Study Type: Interventional
• Study Design: Not specified