A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

简要总结

主要结局

次要结局

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 52)
• Number of Participants With Clinically Significant Laboratory Abnormalities(Baseline up to Week 52)
• Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03(Baseline up to Week 52)
• Percentage of Participants With Complete Remission (CR) at Week 26(Week 26)
• Duration of Response (DOR)(From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52)
• Time to Treatment Failure (TTF)(From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52)
• Progression-Free Survival (PFS)(From randomization until disease progression or death due to any cause or up to Week 52)
• Overall Survival(From randomization until death due to any cause or up to Week 52)
• Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Week 52)
• Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03(Baseline up to Week 52)
• Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU(Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22)
• Cluster of Differentiation (CD) 19-Positive B-Cell Counts(Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52)
• Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)(Baseline up to Week 52)
• Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU(Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22)
• Number of Participants Reporting Immune-Based Adverse Effects(Baseline up to Week 52)