A Study of RO5072759 (GA101) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma

Phase 1

• Conditions: INDOLENT NON-HODGKIN'S LYMPHOMA; MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024132-41-BE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-28
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1401

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 504
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 252

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

Study & Design

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