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Trial · NCT03671018

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryMaximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab VedotinCycle 1 to Cycle 2 (cycle length = 21 days)
PrimaryRecommended Phase II Dose of Mosunetuzumab in Combination with Polatuzumab VedotinCycle 1 to Cycle 2 (cycle length = 21 days)
PrimaryPercentage of Participants with Adverse Events (AE)Baseline through approximately 90 days after last study treatment
Primary
Best Objective Response Rate (ORR), Defined as CR or Partial Response (PR) at any Time, Based on PET-CT and/or CT Scan, as Determined by the Independent Review Committee (IRC) using Standard Criteria for NHL
Baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)
SecondaryBest ORR (CR or PR at any Time) Based on PET-CT and/or CT Scan, as Determined by the Investigator Using Standard Criteria for NHL
Baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)
SecondaryBest CR Rate on Study Based on PET-CT, and/or CT Scan, as Determined by the Investigator and IRC Using Standard Criteria for NHL
Baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)
SecondaryCR Rate at the Time of Primary Response Assessment (PRA) Based on PET-CT, as Determined by the Investigator and IRC Using Standard Criteria for NHLCycle 8 completion (participants receiving mosunetuzumab), or 5-7 weeks after Cycle 6 (polatuzumab+bendamustine+rituximab participants) (Cycle = 21 days)
SecondaryORR, Defined as CR or PR, at PRA Based on PET-CT as Determined by the Investigator and IRC Using Standard Criteria for NHLCycle 8 completion (participants receiving mosunetuzumab), or 5-7 weeks after Cycle 6 (polatuzumab+bendamustine+rituximab participants) (Cycle = 21 days)
SecondaryDuration of Response (DOR) as Determined by the Investigator and IRC Using Standard Criteria for NHLFrom the first occurrence of a documented response to disease progression, relapse, or death from any cause, whichever occurs first (up to approximately 60 months)
SecondaryProgression-Free Survival (PFS) as Determined by the Investigator and IRC Using Standard Criteria for NHLFrom time of first study treatment to the first occurrence of disease progression, relapse, or death from any cause, whichever occurs first (up to approximately 60 months)
SecondaryEvent-Free Survival (EFS) as Determined by the Investigator and IRC Using Standard Criteria for NHL
From time of first study treatment to the first occurrence of disease progression, relapse, initiation of new anti-lymphoma treatment (NALT), or death from any cause, whichever occurs first (up to approximately 60 months)
SecondaryOverall Survival (OS)From time of first study treatment to death from any cause (up to approximately 60 months)
SecondaryAnti-Drug Antibodies (ADAs) to MosunetuzumabAt pre-defined intervals from C1D1 through approximately 90 days after the last study treatment
SecondaryADAs to Polatuzumab VedotinAt pre-defined intervals from C1D1 through approximately 90 days after the last study treatment
SecondaryMosunetuzumab Serum ConcentrationAt pre-defined intervals from C1D1 through approximately 90 days after the last study treatment

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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