A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma

Brief Summary

Primary Outcomes

Secondary Outcomes

• Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population(At the end of treatment (Month 6))
• Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population(At the end of treatment (Month 6))
• Number of Participants With Anti-Polatuzumab Vedotin Antibodies(Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days))
• Number of Participants With Anti-Obinutuzumab Antibodies(Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days))
• Plasma Levels of Cyclophosphamide(End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days))
• Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin(Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days))
• Maximum Concentration (Cmax) of Polatuzumab Vedotin(Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days))
• Clearance (CL) of Polatuzumab Vedotin(Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days))
• Terminal Half-Life (t1/2) of Polatuzumab Vedotin(Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days))
• Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin(Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days))
• Plasma Levels of Doxorubicin(2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days))
• Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score(Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.)
• Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score(Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.)
• Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population(6 months)
• Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population(Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years))
• Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population(6 months)
• Overall Survival for DLBCL Population(Screening up to death due to any cause (up to approximately 6 years))
• Overall Survival for Non-DLBCL Population(Screening up to death due to any cause (up to approximately 6 years))