Trial · NCT03677141
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. The primary efficacy analysis compared Arm 1 vs Arm 2, with participants grouped according to the treatment arm assigned at randomization. Group C was included in secondary efficacy analysis, and efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| 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 | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| 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 | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| 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 | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II) | Up to approximately 50 months | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of responders | NUMBER |
| SECONDARY | Duration of Response (DOR) as Determined by the Investigator (Phase II) | Up to approximately 50 months | The number of participants analyzed was the number of participants with a PR or CR in each arm. 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). Efficacy analyses for Arms A1, A2, and B were exploratory. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Determined by the Investigator (Phase II) | Up to approximately 50 months | Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. 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). | Months | MEDIAN |
| SECONDARY | PFS at 1 Year as Determined by the Investigator (Phase II) | 1 year | Efficacy analyses for Arms A1, A2, and B were exploratory. | Percentage of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) as Determined by the Investigator (Phase II) | Up to 50 months | Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment or documentation of NALT were censored at the date of randomization or first study treatment, plus 1 day). | Months | MEDIAN |
| 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) | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol. | Months | MEDIAN |
| 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) | The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol. | Months | MEDIAN |
| SECONDARY | Polatuzumab Vedotin Serum Concentrations | C2D1, C6D1 | Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations | C1D1-C6D1 | Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations | C1D1-C6D1 | Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Mosunetuzumab Serum Concentrations | C1D1-C5D1 | Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive mosunetuzumab were not included in this endpoint. | ug/mL | GEOMETRIC_MEAN |
| 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) | The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants. | Number of participants | NUMBER |
| 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) | The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants. | Number of participants | NUMBER |
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/NCT03677141/outcomes