A study comparing PF-05280586 to MabThera® (rituximab) in patients with follicular lymphoma who have not received previous treatment.

Phase 3

Completed

• Conditions: Health Condition 1: null- CD20-positive, low tumor burden, Follicular Lymphoma

• Registration Number: CTRI/2015/05/005811
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma)

• Ann Arbor Stage II, III, or IV

• Eastern Cooperative Oncology Group (ECOG) status of 0 to 1

• At least 1 measureable disease lesion of at least 1.5 cm in longest diameter

Exclusion Criteria

• Not a candidate for treatment with rituximab as a single-agent

• Evidence of transformation to a high grade or diffuse large B-cell lymphoma

• Central nervous system or meningeal involvement or cord compression by the lymphoma.

• T-cell lymphoma.

• Any prior treatment for lymphoma

• Any prior treatment with rituximab

• Active, uncontrolled infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified