Trial · NCT01992653
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
NCT01992653, Phase 1, Phase 2, Completed, Genentech, Inc.; results first posted 2020-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma. Trials, record NCT01992653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01992653
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT01992653
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Lymphoma, Non Hodgkin
- Interventions
- Cyclophosphamide, Doxorubicin, Obinutuzumab, Polatuzumab Vedotin, Prednisolone, Prednisone, Rituximab
- First posted
- 2013-11-25
- Last updated
- 2023-03-14
- Other registries' IDs
- eudract:2013-003541-42
- Results first posted
- 2020-03-03
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Baseline up to 5 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). |
| Primary | Number of Participants With Adverse Events in Non-DLBCL Population | Baseline up to 5 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). |
| 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) | All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. |
| Primary | Number of Participants With DLTs in Non-DLBCL Population | Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days) | All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. |
| 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) | Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. |
| 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) | Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. |
| 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 Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from \<0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL. |
| 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 ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA. |
| 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) | AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. |
| 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) | Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (1.0mg) + R-CHP | 2 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (1.4mg) + R-CHP | 3 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (1.8mg) + R-CHP | 5 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (2.4mg) + R-CHP | 0 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (1.4mg) + G-CHP | 4 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Polatuzumab Vedotin (1.8mg) + G-CHP | 4 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 40 | Participants | ||
| Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population | Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17 | Participants | ||
| Number of Participants With Adverse Events in Non-DLBCL Population | Polatuzumab Vedotin (1.0mg) + R-CHP | 1 | Participants | ||
| Number of Participants With Adverse Events in Non-DLBCL Population | Polatuzumab Vedotin (1.4mg) + R-CHP | 0 | Participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polatuzumab Vedotin (1.0mg) + R-CHP | 3 | |
| Overall Study | STARTED | Polatuzumab Vedotin (1.4mg) + R-CHP | 3 | |
| Overall Study | STARTED | Polatuzumab Vedotin (1.8mg) + R-CHP | 6 | |
| Overall Study | STARTED | Polatuzumab Vedotin (2.4mg) + R-CHP | 1 | |
| Overall Study | STARTED | Polatuzumab Vedotin (1.4mg) + G-CHP | 6 | |
| Overall Study | STARTED | Polatuzumab Vedotin (1.8mg) + G-CHP | 6 | |
| Overall Study | STARTED | Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 40 | |
| Overall Study | STARTED | Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 17 | |
| Overall Study | COMPLETED | Polatuzumab Vedotin (1.0mg) + R-CHP | 3 | |
| Overall Study | COMPLETED | Polatuzumab Vedotin (1.4mg) + R-CHP | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,896
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.0mg) + R-CHP | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.4mg) + R-CHP | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.8mg) + R-CHP | 0 | 6 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (2.4mg) + R-CHP | 0 | 1 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.4mg) + G-CHP | 3 | 6 | 4 |
| other | ANAEMIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.8mg) + G-CHP | 2 | 6 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 14 | 40 | 24 |
| other | ANAEMIA | Blood and lymphatic system disorders | Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 3 | 17 | 7 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.0mg) + R-CHP | 0 | 3 | 0 |
| other | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Polatuzumab Vedotin (1.4mg) + R-CHP | 0 | 3 | 0 |
1 to 10 of 1,896Source ClinicalTrials.gov
See all 1,896 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Polatuzumab Vedotin (1.0mg) + R-CHP | 0 | 3 |
| Total, all-cause mortality | Polatuzumab Vedotin (1.4mg) + R-CHP | 0 | 3 |
| Total, all-cause mortality | Polatuzumab Vedotin (1.8mg) + R-CHP | 1 | 6 |
| Total, all-cause mortality | Polatuzumab Vedotin (2.4mg) + R-CHP | 0 | 1 |
| Total, all-cause mortality | Polatuzumab Vedotin (1.4mg) + G-CHP | 1 | 6 |
| Total, all-cause mortality | Polatuzumab Vedotin (1.8mg) + G-CHP | 0 | 6 |
| Total, all-cause mortality | Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP | 4 | 40 |
| Total, all-cause mortality | Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP | 2 | 17 |
| Total, other adverse events | Polatuzumab Vedotin (1.0mg) + R-CHP | 3 | 3 |
| Total, other adverse events | Polatuzumab Vedotin (1.4mg) + R-CHP | 3 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01992653
GET https://conductscience.org/api/trials/v1/NCT01992653/registered?page=2