A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma

Phase 1

• Conditions: PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); MedDRA version: 20.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004943; MedDRA version: 20.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024194-39-AT
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Adult patients, >/= 18 years of age
Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Adequate hematological function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or any component of CHOP or GA101
Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
Diagnosis of transformed lymphoma (follicular IIIB) if previously treated with radiotherapy, chemotherapy, or immunotherapy
Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
Prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody
Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
Ongoing corticosteroid use of > 30 mg/day of prednisone or equivalent, for purposes other then lymphoma symptom control
Primary CNS lymphoma and secondary CNS invilvement by lymphoma, MCL, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL
Patients with a history of confirmed PML

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified