Trial · NCT02600897
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase | The safety-evaluable population included all participants who received at least one dose of any component of the combination. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | From study start up to end of study (Up to a maximum of 69 months) | The safety-evaluable population included all participants who received at least one dose of any component of the combination. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Complete Response (CR) at End of Induction (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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (cycle=28 days) (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Response of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone | Up to every 6 months until disease progression, unacceptable toxicity or study completion (up to approximately 69 months) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | NUMBER |
| SECONDARY | Observed Serum Obinutuzumab Concentration | Day 1 of Cycles 1, 2, 4 & 6: predose & 30 mins postdose; EOI: predose; Day 1 of Maintenance Months 1,7, 13, 19;Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months) | The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable postdose PK sample. '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 a specified timepoint. | micrograms per milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Observed Serum Rituximab Concentration | Day 1 of Cycles 1, 2, 4, 6: predose and 30 mins post-dose (1 cycle = 28 days) (up to approximately 69 months) | The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. '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 a specified timepoint. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody | Day 1 of Cycles 1, 2, 4: predose (1 cycle = 28 days), Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months) | The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. '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 a specified timepoint. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) | Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1; Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months) | The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. '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 a specified timepoint. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE | Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1 and Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months) | The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. '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 a specified timepoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Observed Plasma Lenalidomide Concentration | Day 1 Cycle 1: predose and 2 hours (hr) post-dose; Day 15 Cycle 1: predose, 0.5hr, 1hr, 2hr, 4hr, 8hr post-dose; Day 1 Cycle 6: 2hr post-dose; unscheduled visits: 2hr post-dose (1 cycle = 28 days) (up to approximately 69 months) | The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. '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 a specified timepoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Human Anti-human Antibodies (HAHAs) to Obinutuzumab | Baseline up to approximately 2 years after last dose (up to approximately 69 months) | Immunogenicity population included all safety-evaluable participants with at least one ADA Sample. '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 a specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Human Anti-chimeric Antibodies (HACAs) to Rituximab | Baseline up to approximately 2 years after last dose (up to approximately 69 months) | Immunogenicity population included all safety-evaluable participants with at least one ADA Sample. '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 a specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin | Baseline up to approx. 2 years after the last dose of polatuzumab vedotin (up to approximately 30 months) | Immunogenicity population included all safety-evaluable participants with at least one ADA sample. Due to missing baseline or post-baseline results not every participant was evaluable for baseline prevalence or post-baseline incidence of ADAs. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
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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