Trial · NCT01992653
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Baseline up to 5 years | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events in Non-DLBCL Population | Baseline up to 5 years | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population | Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With DLTs in Non-DLBCL Population | Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population | At the end of treatment (Month 6) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population | At the end of treatment (Month 6) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Anti-Polatuzumab Vedotin Antibodies | Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-Obinutuzumab Antibodies | Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin | Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | ng day/mL | MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Polatuzumab Vedotin | Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | ng/mL | MEAN |
| SECONDARY | Clearance (CL) of Polatuzumab Vedotin | Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | mL/day/kg | MEAN |
| SECONDARY | Terminal Half-Life (t1/2) of Polatuzumab Vedotin | Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | days | MEAN |
| SECONDARY | Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin | Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL. | mL/kg | MEAN |
| SECONDARY | Plasma Levels of Cyclophosphamide | End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of cyclophosphamide were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis. | ug/mL | MEAN |
| SECONDARY | Plasma Levels of Doxorubicin | 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days) | The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of doxorubicin were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis. | ug/mL | MEAN |
| SECONDARY | Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score | Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected. | The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis. | Score of a Questionnaire | MEAN |
| SECONDARY | Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score | Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected. | The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis. | Score of a Questionnaire | MEAN |
| SECONDARY | Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population | Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL. | Months | MEDIAN |
| SECONDARY | Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population | Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL. | Months | MEDIAN |
| SECONDARY | Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population | Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years) | The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL. | Months | MEDIAN |
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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