Trial · NCT03677141
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) | 6-8 weeks after either C6D1 or last dose of study treatment | The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria. |
| Secondary | CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | |
| Secondary | Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | ORR is defined as a CR or PR at the time of primary assessment based on PET-CT, as determined by the investigator. |
| Secondary | ORR at PRA Based on CT Only as Determined by the Investigator (Phase II) | 6-8 weeks after C6D1 or last dose of study treatment | ORR is defined as a CR or PR at the time of primary assessment based on CT only, as determined by the investigator. |
| Secondary | Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II) | Up to approximately 50 months | Best ORR was defined as CR or PR at any time on study and based on PET-CT or CT only as determined by the investigator. |
| Secondary | Duration of Response (DOR) as Determined by the Investigator (Phase II) | Up to approximately 50 months | DOR is defined as the time from the first occurrence of a documented objective response to disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). |
| Secondary | Progression-free Survival (PFS) as Determined by the Investigator (Phase II) | Up to approximately 50 months | PFS is defined as the time from randomization to the first occurrence of disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The earliest contributing event to PFS is reported. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day). |
| Secondary | PFS at 1 Year as Determined by the Investigator (Phase II) | 1 year | PFS at 1 year is defined as the proportion of participants with disease progression or relapse as determined by the investigator, or death from any cause within 1 year of randomization. |
| Secondary | Event-free Survival (EFS) as Determined by the Investigator (Phase II) | Up to 50 months | EFS is defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). |
| Secondary | Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale | C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation) | |
| Secondary | Time to Deterioration in Physical Functioning and Fatigue as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30) | C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation) | |
| Secondary | Polatuzumab Vedotin Serum Concentrations | C2D1, C6D1 | |
| Secondary | Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations | C1D1-C6D1 | |
| Secondary | Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations | C1D1-C6D1 | |
| Secondary | Mosunetuzumab Serum Concentrations | C1D1-C5D1 | |
| Secondary | Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab | Cycles 1, 2, 6, 16, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment) | Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected). |
| Secondary | Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin | Cycles 1, 2, 6, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment) | Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected). |
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
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GET https://conductscience.org/api/trials/v1/NCT03677141/registered