Trial · NCT02611323
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
NCT02611323, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2023-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL). Trials, record NCT02611323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02611323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
- NCT number
- NCT02611323
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 133 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Obinutuzumab, Rituximab, Polatuzumab Vedotin, Venetoclax
- First posted
- 2015-11-20
- Last updated
- 2023-10-10
- Other registries' IDs
- eudract:2015-001998-40
- Results first posted
- 2023-10-10
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions. No new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point. |
| 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) | An AE was defined as 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 AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). Percentages have been rounded off to the first decimal point. |
| 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) | An AE was defined as 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 AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease were also considered as AEs. An SAE was defined as any AE that was fatal, life threatening, requires prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to a mother exposed to study treatment. AEs and SAEs were reported based on the NCI-CTCAE, v4.0. Percentages have been rounded off to the first decimal point. |
| 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 | DLT=any one of the events that occurred in first treatment cycle \& per the investigator was related to study treatment. Any AE that lead to a delay of \> 14 days in start of next treatment cycle; Any Grade 3/4 non-hematologic AE with few exceptions; Any increase in hepatic transaminase \>3×baseline(BL) \& increase in direct bilirubin \>2×upper limit of normal (ULN), without any findings of cholestasis/jaundice/signs of hepatic dysfunction \& in absence of other contributory factors; Grade1 alanine transaminase (ALT)/aspartate transaminase (AST) elevation at BL as result of liver metastases, only a Grade ≥3 elevation, also ≥3×BL lasting \>7 days; Hematologic AE meeting protocol specified criteria. Events were graded per NCI CTCAE v4.0. Grade 1:Mild; asymptomatic/mild symptoms; Grade 2:Moderate;minimal,local/non-invasive intervention indicated; Grade 3:Severe/medically significant, but not immediately life-threatening; Grade 4:Life-threatening consequences/urgent intervention indicated. |
| Primary | RP2D of Polatuzumab Vedotin | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase | RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of polatuzumab vedotin when given in combination with fixed dose of obinutuzumab in participants with FL was determined. |
| Primary | RP2D of Venetoclax | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle=21 days) in dose-escalation phase | RP2D was defined as the highest dose with acceptable toxicity as determined from dose-escalation phase. The RP2D of venetoclax when given in combination with fixed dose of polatuzumab vedotin in participants with FL and DLBCL was determined. |
| 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) | CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no evidence of FDG-avid disease in bone marrow. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point. |
| 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) | CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point. |
| 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) | CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. 90% CI for percentage of responders was calculated using Clopper-Pearson method. |
| 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) | OR=percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT=complete MR in lymph nodes \& ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake\> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions \& no evidence of FDG-avid disease in bone marrow. PR based on PET-CT=partial MR in lymph nodes \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size: at interim (suggest responding disease) or at end of treatment (indicate residual disease), residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). 90% CI was calculated using Clopper-Pearson method. Percentages have been rounded off to the first decimal point. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group583
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | FL Dose Escalation: 1.8P+800V+1000G | 100 | 90% Confidence Interval 68.77 to 100.00 | percentage of participants | |
| 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 | FL: Dose Expansion: 1.8P+800V+1000G | 51.2 | 90% Confidence Interval 37.44 to 64.86 | percentage of participants | |
| 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 | DLBCL Dose Escalation: 1.8P+800V+375R | 25 | 90% Confidence Interval 4.64 to 59.97 | percentage of participants | |
| 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 | DLBCL Dose Expansion: 1.8P+800V+375R | 32.5 | 90% Confidence Interval 20.41 to 46.63 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.4P+400V+1000G | AEs | 100 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.4P+200V+1000G | AEs | 100 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.8P+400V+1000G | AEs | 100 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.4P+600V+1000G | AEs | 100 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.8P+600V+1000G | AEs | 100 | percentage of participants | |
| FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | FL Dose Escalation: 1.8P+800V+1000G | AEs | 100 | percentage of participants |
1 to 10 of 583Source ClinicalTrials.gov
See all 583 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FL Dose Escalation: 1.4P+400V+1000G | 7 | |
| Overall Study | STARTED | FL Dose Escalation: 1.4P+200V+1000G | 3 | |
| Overall Study | STARTED | FL Dose Escalation: 1.8P+400V+1000G | 3 | |
| Overall Study | STARTED | FL Dose Escalation: 1.4P+600V+1000G | 3 | |
| Overall Study | STARTED | FL Dose Escalation: 1.8P+600V+1000G | 9 | |
| Overall Study | STARTED | FL Dose Escalation: 1.8P+800V+1000G | 8 | |
| Overall Study | STARTED | FL: Dose Expansion: 1.8P+800V+1000G | 41 | |
| Overall Study | STARTED | DLBCL: Dose Escalation: 1.8P+400V+375R | 3 | |
| Overall Study | STARTED | DLBCL Dose Escalation: 1.8P+600V+375R | 6 | |
| Overall Study | STARTED | DLBCL Dose Escalation: 1.8P+800V+375R | 8 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events3,784
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 | FL Dose Escalation: 1.4P+400V+1000G | 1 | 7 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL Dose Escalation: 1.4P+200V+1000G | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL Dose Escalation: 1.8P+400V+1000G | 1 | 3 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL Dose Escalation: 1.4P+600V+1000G | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL Dose Escalation: 1.8P+600V+1000G | 0 | 9 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL Dose Escalation: 1.8P+800V+1000G | 2 | 8 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | FL: Dose Expansion: 1.8P+800V+1000G | 7 | 41 | 13 |
| other | ANAEMIA | Blood and lymphatic system disorders | DLBCL: Dose Escalation: 1.8P+400V+375R | 1 | 3 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | DLBCL Dose Escalation: 1.8P+600V+375R | 2 | 6 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | DLBCL Dose Escalation: 1.8P+800V+375R | 3 | 8 | 4 |
1 to 10 of 3,784Source ClinicalTrials.gov
See all 3,784 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FL Dose Escalation: 1.4P+400V+1000G | 3 | 7 |
| Total, all-cause mortality | FL Dose Escalation: 1.4P+200V+1000G | 1 | 3 |
| Total, all-cause mortality | FL Dose Escalation: 1.8P+400V+1000G | 0 | 3 |
| Total, all-cause mortality | FL Dose Escalation: 1.4P+600V+1000G | 0 | 3 |
| Total, all-cause mortality | FL Dose Escalation: 1.8P+600V+1000G | 1 | 9 |
| Total, all-cause mortality | FL Dose Escalation: 1.8P+800V+1000G | 1 | 8 |
| Total, all-cause mortality | FL: Dose Expansion: 1.8P+800V+1000G | 8 | 41 |
| Total, all-cause mortality | DLBCL: Dose Escalation: 1.8P+400V+375R | 0 | 3 |
| Total, all-cause mortality | DLBCL Dose Escalation: 1.8P+600V+375R | 4 | 6 |
| Total, all-cause mortality | DLBCL Dose Escalation: 1.8P+800V+375R | 6 | 8 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02611323
GET https://conductscience.org/api/trials/v1/NCT02611323/registered?page=2