Trial · NCT03671018
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab Vedotin | Cycle 1 to Cycle 2 (cycle length = 21 days) | |
| Primary | Recommended Phase II Dose of Mosunetuzumab in Combination with Polatuzumab Vedotin | Cycle 1 to Cycle 2 (cycle length = 21 days) | |
| Primary | Percentage 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) | |
| Secondary | Best 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) | |
| Secondary | Best 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) | |
| Secondary | CR Rate at the Time of Primary Response Assessment (PRA) Based on PET-CT, as Determined by the Investigator and IRC Using Standard Criteria for NHL | Cycle 8 completion (participants receiving mosunetuzumab), or 5-7 weeks after Cycle 6 (polatuzumab+bendamustine+rituximab participants) (Cycle = 21 days) | |
| Secondary | ORR, Defined as CR or PR, at PRA Based on PET-CT as Determined by the Investigator and IRC Using Standard Criteria for NHL | Cycle 8 completion (participants receiving mosunetuzumab), or 5-7 weeks after Cycle 6 (polatuzumab+bendamustine+rituximab participants) (Cycle = 21 days) | |
| Secondary | Duration of Response (DOR) as Determined by the Investigator and IRC Using Standard Criteria for NHL | From the first occurrence of a documented response to disease progression, relapse, or death from any cause, whichever occurs first (up to approximately 60 months) | |
| Secondary | Progression-Free Survival (PFS) 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, or death from any cause, whichever occurs first (up to approximately 60 months) | |
| Secondary | Event-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) | |
| Secondary | Overall Survival (OS) | From time of first study treatment to death from any cause (up to approximately 60 months) | |
| Secondary | Anti-Drug Antibodies (ADAs) to Mosunetuzumab | At pre-defined intervals from C1D1 through approximately 90 days after the last study treatment | |
| Secondary | ADAs to Polatuzumab Vedotin | At pre-defined intervals from C1D1 through approximately 90 days after the last study treatment | |
| Secondary | Mosunetuzumab Serum Concentration | At 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03671018/registered