Trial · NCT02611323
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With CR at EOI Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21 days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at recommended phase 2 dose (RP2D) in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| PRIMARY | FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From study start to 24 months after last dose of study drug (approximately 56 months) | Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | DLBCL Cohorts: Percentage of Participants With AEs and SAEs | From study start to 3 months after last dose of study drug (approximately 21 months) | Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Dose-Limiting Toxicities (DLTs) | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase | Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the dose-escalation cohorts cohorts were assessed in this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | RP2D of Polatuzumab Vedotin | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase | Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the FL cohorts were assessed in this outcome measure. | mg/kg | NUMBER |
| PRIMARY | RP2D of Venetoclax | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase | Safety-evaluable population included all participants who received at least one dose of any component of the combination. The safety-evaluable population in the DLBCL cohorts were assessed in this outcome measure. | mg | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. Overall number analyzed is the number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) at EOI, Determined by an IRC on the Basis of PET and CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of PET and CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOI, Determined by an IRC on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone | Up to every 6 months until disease progression, the start of new anti-lymphoma treatment, or the end of the study, whichever occurs first (approximately 77 months) | Efficacy evaluable population included participants in the dose expansion arms who received at least one dose of any component of the combination. As pre-specified in the protocol, participants who received polatuzumab vedotin and venetoclax at RP2D in dose-escalation phase were also analyzed in addition to expansion phase participants for efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Observed Serum Obinutuzumab Concentration | Pre-dose & 0.5 hours post-dose on Day 1 Cycles 1, 2, 4, & 6; and pre-dose on Day 1 of Months 2, 8, 14, 20; study drug discontinuation, Day 120 &1 year post-last dose (up to approximately 40 months) (1 cycle = 21 days) | Pharmacokinetics (PK) evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | micrograms per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Observed Serum Rituximab Concentration | Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1 and 6; pre-dose on Day 1 of Cycles 2 and 4; (1 cycle = 21 days) | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Observed Serum Concentration of Total Antibody to Polatuzumab Vedotin | Pre-dose on Day 1 of Cycles 1, 2 and 4; study drug discontinuation visit; Day 120 and 1 year post-last dose (up to approximately 16 months) (1 cycle=21 days) | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Observed Plasma Concentration of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (MMAE) (acMMAE) | Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days) | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Observed Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE | Pre-dose and 0.5 hours post-dose on Day 1 of Cycles 1, 2 and 4; post-dose on Days 8 and 15 of Cycle 1; predose on Day 1 of Cycle 6 (1 cycle=21 days) | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Observed Plasma Venetoclax Concentration | Pre-dose and 4 hours post-dose on Day 1 Cycle 1, pre-dose & 2, 4, 6, & 8 hours post-dose on Day 1 Cycle 2, pre-dose & 4hours post-dose on Day 1 Cycle 4 & pre-dose on Day 1 Cycle 6; (1 cycle = 21 days) | PK-evaluable population included all participants who had at least one evaluable PK sample post dose for at least one analyte. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | µg/mL | GEOMETRIC_MEAN |
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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