Trial · NCT02729896
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT02729896, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2019-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Trials, record NCT02729896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02729896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- NCT number
- NCT02729896
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphoma
- Interventions
- Atezolizumab [TECENTRIQ], Obinutuzumab, Polatuzumab Vedotin, Rituximab
- First posted
- 2016-04-06
- Last updated
- 2020-12-23
- Other registries' IDs
- eudract:2015-004845-25
- Results first posted
- 2019-11-05
Source ClinicalTrials.gov
Registered outcomes14
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, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Secondary | Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Tumor response assessment was performed by investigator according to modified Lugano classification using computed tomography (CT) scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to \<= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Secondary | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake \</=mediastinum), or 3 (uptake \<mediastinum but \</=liver) with or without a residual mass on PET 5-PS, for lymph nodes \& extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population |
| Secondary | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to \<= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with \>= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes \& extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by \> 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Secondary | Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone | Baseline up to 35 months | Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR: a response of CR or PR. CR: Target nodes/nodal masses regressed to \<= 1.5 cm in LDi; no extralymphatic sites of disease; organ enlargement regressed to normal; no new lesions; normal/IHC-negative bone marrow morphology. PR with \>= 50 percet decrease in SPD of up to six target measurable nodes and extranodal sites, a 5 mm x 5 mm default value when lesions were too small, 0 x0 mm value when lesions were no longer visible, actual measurements were used for nodes greater than 5 mm x 5 mm for lymph nodes \& extralymphatic sites; absent/normal, regression for non-measured lesion; spleen enlargement regression by \> 50 percent; no new lesions; reduced residual uptake in bone marrow compared to baseline. All CT evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. |
| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | Baseline up to 35 months | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable 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. Grading was completed according to the CTCAE, version 4.0 for severity and tumor flare reactions were graded according to NCI CTCAE v3.0. |
| Secondary | Serum Obinutuzumab Concentration | Pre-dose (0 hr) up to 35 months | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 4, 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and decreases every 30 min to maximum of 400 mg/hr) |
| Secondary | Serum Rituximab Concentration | Pre-dose (0 hr) up to 35 months | pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycle 6; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increases every 30 min to maximum of 400 mg/hr) |
| Secondary | Serum Atezo Concentration | Pre-dose (0 hr) up to 35 months | pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 3, 4; pre-dose (within 5 hr) on Day 1 of Cycle 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Month 1; 30 min after EOI on Day 2 of Month 1; pre-dose (within 5 hr) on Day 1 of Month 4, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1-2 years after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min) |
| Secondary | Serum Pola Concentration | Pre-dose (0 hr) up to 35 months | pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to 35 months (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone | Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months) | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone | Baseline up to 35 months | Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events and Serious Adverse Events | Baseline up to 35 months | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Serum Obinutuzumab Concentration | Pre-dose (0 hr) up to 35 months | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | mcg/mL | MEAN |
| SECONDARY | Serum Rituximab Concentration | Pre-dose (0 hr) up to 35 months | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | mcg/mL | MEAN |
| SECONDARY | Serum Atezo Concentration | Pre-dose (0 hr) up to 35 months | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | mcg/mL | MEAN |
| SECONDARY | Serum Pola Concentration | Pre-dose (0 hr) up to 35 months | The Safety Evaluable Population that includes patients who received at least one dose of any study treatment. | mcg/mL | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group148
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, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | Dose-Escalation FL Cohort 1.4 mg | 33.33 | Percentage of participants | ||
| Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | Dose-Escalation and Expansion FL Cohort 1.8 mg | 14.30 | Percentage of participants | ||
| Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan | Safety Run-In Phase | 12.50 | Percentage of participants | ||
| Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Dose-Escalation FL Cohort 1.4 mg | 0.00 | Percentage of participants | ||
| Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Dose-Escalation and Expansion FL Cohort 1.8 mg | 57.14 | Percentage of participants | ||
| Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone | Safety Run-In Phase | 12.50 | Percentage of participants | ||
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | Dose-Escalation FL Cohort 1.4 mg | 33.33 | Percentage of participants | ||
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | Dose-Escalation and Expansion FL Cohort 1.8 mg | 57.14 | Percentage of participants | ||
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans | Safety Run-In Phase | 25.00 | Percentage of participants | ||
| Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone | Dose-Escalation FL Cohort 1.4 mg | 33.33 | Percentage of participants |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-Escalation FL Cohort 1.4 mg | 3 | |
| Overall Study | STARTED | Dose-Escalation and Expansion FL Cohort 1.8 mg | 10 | |
| Overall Study | STARTED | Safety Run-in and Expansion DLBCL Cohort | 23 | |
| Overall Study | COMPLETED | Dose-Escalation FL Cohort 1.4 mg | 1 | |
| Overall Study | COMPLETED | Dose-Escalation and Expansion FL Cohort 1.8 mg | 1 | |
| Overall Study | COMPLETED | Safety Run-in and Expansion DLBCL Cohort | 1 | |
| Overall Study | NOT COMPLETED | Dose-Escalation FL Cohort 1.4 mg | 2 | |
| Overall Study | NOT COMPLETED | Dose-Escalation and Expansion FL Cohort 1.8 mg | 9 | |
| Overall Study | NOT COMPLETED | Safety Run-in and Expansion DLBCL Cohort | 22 |
Source ClinicalTrials.gov
Adverse events333
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 | Dose-Escalation FL Cohort 1.4 mg | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-Escalation and Expansion FL Cohort 1.8 mg | 1 | 10 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Safety Run-in and Expansion DLBCL Cohort | 2 | 21 | 2 |
| other | ANAEMIA FOLATE DEFICIENCY | Blood and lymphatic system disorders | Dose-Escalation FL Cohort 1.4 mg | 0 | 3 | 0 |
| other | ANAEMIA FOLATE DEFICIENCY | Blood and lymphatic system disorders | Dose-Escalation and Expansion FL Cohort 1.8 mg | 1 | 10 | 1 |
| other | ANAEMIA FOLATE DEFICIENCY | Blood and lymphatic system disorders | Safety Run-in and Expansion DLBCL Cohort | 0 | 21 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Dose-Escalation FL Cohort 1.4 mg | 0 | 3 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Dose-Escalation and Expansion FL Cohort 1.8 mg | 2 | 10 | 5 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Safety Run-in and Expansion DLBCL Cohort | 1 | 21 | 1 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Dose-Escalation FL Cohort 1.4 mg | 1 | 3 | 1 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-Escalation FL Cohort 1.4 mg | 0 | 3 |
| Total, all-cause mortality | Dose-Escalation and Expansion FL Cohort 1.8 mg | 2 | 10 |
| Total, all-cause mortality | Safety Run-in and Expansion DLBCL Cohort | 13 | 23 |
| Total, other adverse events | Dose-Escalation FL Cohort 1.4 mg | 3 | 3 |
| Total, other adverse events | Dose-Escalation and Expansion FL Cohort 1.8 mg | 10 | 10 |
| Total, other adverse events | Safety Run-in and Expansion DLBCL Cohort | 15 | 21 |
| Total, serious adverse events | Dose-Escalation FL Cohort 1.4 mg | 0 | 3 |
| Total, serious adverse events | Dose-Escalation and Expansion FL Cohort 1.8 mg | 4 | 10 |
| Total, serious adverse events | Safety Run-in and Expansion DLBCL Cohort | 2 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35182224 | DERIVED |
Source PubMed
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.
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