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Trial · NCT02257567

Registered outcomes78

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryPhase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1bCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and CCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: AUCinf of Bendamustine and Rituximab in Arms B and DCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
SecondaryPhase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and FCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryArm H (Phase II NF Cohort): AUC of Polatuzumab Vedotin (Lyophilized)Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeksPK of three pola-related analytes: antibody acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1aCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1bCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and CCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: CL of Bendamustine and Rituximab in Arms B and DCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
SecondaryPhase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and FCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryArm H (Phase II NF Cohort): CL of Polatuzumab Vedotin (Lyophilized)Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeksPK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1aCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1bCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and CCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryPhase II: Vss of Bendamustine and Rituximab in Arms B and DCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
SecondaryPhase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and FCycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondaryArm H (Phase II NF Cohort): Vss of Polatuzumab Vedotin (Lyophilized)Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeksPK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
SecondarySymptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-FEvery week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall)
The TINAS is an 11-item questionnaire that assesses the severity of neuropathy-related symptoms in the last 24 hours. The 11 items assessed were: hot/burning sensations in hands/feet, sensations pins and needles arms/legs, numbness or tingling in hands/feet, sensations of electric shock, pain when touching cold things, cramps in hands/feet, discomfort when touching things, discomfort skin contact with something, trouble grasping small objects, trouble walking loss feeling legs/feet, difficulty balance loss feeling leg/feet. Each item was scored on a 0-10 scale, with 0 being the symptom is not present, and 10 being the symptom is as bad as the participant can imagine. Higher scores indicate more severe disease. Scores were averaged at each week.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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