NCT02611323 is a Phase 1, PHASE2 clinical trial of Obinutuzumab in Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT02611323?

NCT02611323 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT02611323?

Interventions in NCT02611323: Obinutuzumab, Rituximab, Polatuzumab Vedotin, Venetoclax.

What condition does NCT02611323 study?

NCT02611323 studies Non-Hodgkin's Lymphoma.

Is NCT02611323 still recruiting?

NCT02611323 is currently completed. Last updated 10 October 2023.

Are results published for NCT02611323?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-10 · How we verify

NCT02611323

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

Completed Phase 1, PHASE2 Results posted Last updated 10 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Obinutuzumab in Non-Hodgkin's Lymphoma in 133 participants. Completed in 4 August 2022.

Timeline

9 March 2016

Primary endpoint
4 August 2022

4 August 2022

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	133
Start date	9 March 2016
Primary completion	4 August 2022
Estimated completion	4 August 2022
Sites	23 locations across Italy, United States, Australia

Drugs / interventions tested

Obinutuzumab — full drug profile →
Rituximab — full drug profile →
Polatuzumab Vedotin (POLATUZUMAB VEDOTIN) — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	100	68.77 – 100.00
FL: Dose Expansion: 1.8P+800V+1000G	51.2	37.44 – 64.86
DLBCL Dose Escalation: 1.8P+800V+375R	25	4.64 – 59.97
DLBCL Dose Expansion: 1.8P+800V+375R	32.5	20.41 – 46.63

FL Cohorts: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · 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 sig

AEs

Group	Value	95% CI
FL Dose Escalation: 1.4P+400V+1000G	100
FL Dose Escalation: 1.4P+200V+1000G	100
FL Dose Escalation: 1.8P+400V+1000G	100
FL Dose Escalation: 1.4P+600V+1000G	100
FL Dose Escalation: 1.8P+600V+1000G	100
FL Dose Escalation: 1.8P+800V+1000G	100
FL: Dose Expansion: 1.8P+800V+1000G	100

SAEs

Group	Value	95% CI
FL Dose Escalation: 1.4P+400V+1000G	57.1
FL Dose Escalation: 1.4P+200V+1000G	33.3
FL Dose Escalation: 1.8P+400V+1000G	33.3
FL Dose Escalation: 1.4P+600V+1000G	0
FL Dose Escalation: 1.8P+600V+1000G	22.2
FL Dose Escalation: 1.8P+800V+1000G	75.0
FL: Dose Expansion: 1.8P+800V+1000G	34.1

DLBCL Cohorts: Percentage of Participants With AEs and SAEs Primary · From study start to 3 months after last dose of study drug (approximately 21 months)

AEs

Group	Value	95% CI
DLBCL: Dose Escalation: 1.8P+400V+375R	100
DLBCL Dose Escalation: 1.8P+600V+375R	100
DLBCL Dose Escalation: 1.8P+800V+375R	87.5
DLBCL Dose Expansion: 1.8P+800V+375R	97.5

SAEs

Group	Value	95% CI
DLBCL: Dose Escalation: 1.8P+400V+375R	100
DLBCL Dose Escalation: 1.8P+600V+375R	66.7
DLBCL Dose Escalation: 1.8P+800V+375R	25.0
DLBCL Dose Expansion: 1.8P+800V+375R	30.0

Number of Participants With Dose-Limiting Toxicities (DLTs) Primary · 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, o

Group	Value	95% CI
FL Dose Escalation: 1.4P+400V+1000G	1
FL Dose Escalation: 1.4P+200V+1000G	0
FL Dose Escalation: 1.8P+400V+1000G	0
FL Dose Escalation: 1.4P+600V+1000G	0
FL Dose Escalation: 1.8P+600V+1000G	2
FL Dose Escalation: 1.8P+800V+1000G	1
DLBCL: Dose Escalation: 1.8P+400V+375R	0
DLBCL Dose Escalation: 1.8P+600V+375R	1
DLBCL Dose Escalation: 1.8P+800V+375R	0

RP2D of Polatuzumab Vedotin Primary · 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.

Group	Value	95% CI
All FL Participants: Dose Escalation	1.8

RP2D of Venetoclax Primary · 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.

Group	Value	95% CI
All FL Participants: Dose Escalation	800
All DLBCL Participants: Dose Escalation	800

Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans Secondary · 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.

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	100	68.77 – 100.00
FL: Dose Expansion: 1.8P+800V+1000G	51.2	37.44 – 64.86
DLBCL Dose Escalation: 1.8P+800V+375R	25.0	4.64 – 59.97
DLBCL Dose Expansion: 1.8P+800V+375R	32.5	20.41 – 46.63

Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone Secondary · 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.

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	62.5	28.92 – 88.89
FL: Dose Expansion: 1.8P+800V+1000G	36.6	24.08 – 50.61
DLBCL Dose Escalation: 1.8P+800V+375R	16.7	0.85 – 58.18
DLBCL Dose Expansion: 1.8P+800V+375R	26.5	14.56 – 41.65

Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of CT Scans Alone Secondary · 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.

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	75.0	40.03 – 95.36
FL: Dose Expansion: 1.8P+800V+1000G	29.3	17.84 – 43.07
DLBCL Dose Escalation: 1.8P+800V+375R	25.0	4.64 – 59.97
DLBCL Dose Expansion: 1.8P+800V+375R	22.5	12.27 – 35.98

Percentage of Participants With Objective Response (OR) at EOI, Determined by an IRC on the Basis of PET and CT Scans Secondary · 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

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	100.0	68.77 – 100.00
FL: Dose Expansion: 1.8P+800V+1000G	70.7	56.93 – 82.16
DLBCL Dose Escalation: 1.8P+800V+375R	25.0	4.64 – 59.97
DLBCL Dose Expansion: 1.8P+800V+375R	37.5	24.73 – 51.72

Percentage of Participants With OR at EOI, Determined by the Investigator on the Basis of PET and CT Scans Secondary · 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

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	100.0	68.77 – 100.00
FL: Dose Expansion: 1.8P+800V+1000G	75.6	62.15 – 86.13
DLBCL Dose Escalation: 1.8P+800V+375R	37.5	11.11 – 71.08
DLBCL Dose Expansion: 1.8P+800V+375R	42.5	29.18 – 56.69

Percentage of Participants With OR at EOI, Determined by an IRC on the Basis of CT Scans Alone Secondary · 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 23 weeks) (1 cycle=21days)

OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on 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; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal

Group	Value	95% CI
FL Dose Escalation: 1.8P+800V+1000G	87.5	52.93 – 99.36
FL: Dose Expansion: 1.8P+800V+1000G	82.9	70.31 – 91.70
DLBCL Dose Escalation: 1.8P+800V+375R	25.0	4.64 – 59.97
DLBCL Dose Expansion: 1.8P+800V+375R	37.5	24.73 – 51.72

Adverse events — posted to ClinicalTrials.gov

Time frame: FL cohorts: From study start to 24 months after last dose of study drug (approximately 56 months); DLBCL cohorts: From study start to 3 months after last dose of study drug (approximately 21 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FL Dose Escalation: 1.4P+400V+1000G

Serious: 4/7 (57%)

Deaths: 3/7

FL Dose Escalation: 1.4P+200V+1000G

Serious: 1/3 (33%)

Deaths: 1/3

FL Dose Escalation: 1.8P+400V+1000G

Serious: 1/3 (33%)

Deaths: 0/3

FL Dose Escalation: 1.4P+600V+1000G

Serious: 0/3 (0%)

Deaths: 0/3

FL Dose Escalation: 1.8P+600V+1000G

Serious: 2/9 (22%)

Deaths: 1/9

FL Dose Escalation: 1.8P+800V+1000G

Serious: 6/8 (75%)

Deaths: 1/8

FL: Dose Expansion: 1.8P+800V+1000G

Serious: 14/41 (34%)

Deaths: 8/41

DLBCL: Dose Escalation: 1.8P+400V+375R

Serious: 3/3 (100%)

Deaths: 0/3

DLBCL Dose Escalation: 1.8P+600V+375R

Serious: 4/6 (67%)

Deaths: 4/6

DLBCL Dose Escalation: 1.8P+800V+375R

Serious: 2/8 (25%)

Deaths: 6/8

DLBCL Dose Expansion: 1.8P+800V+375R

Serious: 12/40 (30%)

Deaths: 26/40

Serious adverse events (63 terms)

Reaction	System	FL Dose Escalation: 1.4P+4…	FL Dose Escalation: 1.4P+2…	FL Dose Escalation: 1.8P+4…	FL Dose Escalation: 1.4P+6…	FL Dose Escalation: 1.8P+6…	FL Dose Escalation: 1.8P+8…	FL: Dose Expansion: 1.8P+8…	DLBCL: Dose Escalation: 1.…	DLBCL Dose Escalation: 1.8…	DLBCL Dose Escalation: 1.8…	DLBCL Dose Expansion: 1.8P…
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
PYREXIA	General disorders	—	—	—	—	—	—	—	—	—	—	—
COVID-19 PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
CARDIAC FAILURE	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
CARDIOMYOPATHY	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
CORONARY ARTERY DISEASE	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—
RETINAL DETACHMENT	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
RETINAL TEAR	Eye disorders	—	—	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
CONSTIPATION	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
ADVERSE DRUG REACTION	General disorders	—	—	—	—	—	—	—	—	—	—	—
MUCOSAL INFLAMMATION	General disorders	—	—	—	—	—	—	—	—	—	—	—
LIVER INJURY	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—
BRONCHITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (281 terms — click to expand)

Reaction	System	FL Dose Escalation: 1.4P+4…	FL Dose Escalation: 1.4P+2…	FL Dose Escalation: 1.8P+4…	FL Dose Escalation: 1.4P+6…	FL Dose Escalation: 1.8P+6…	FL Dose Escalation: 1.8P+8…	FL: Dose Expansion: 1.8P+8…	DLBCL: Dose Escalation: 1.…	DLBCL Dose Escalation: 1.8…	DLBCL Dose Escalation: 1.8…	DLBCL Dose Expansion: 1.8P…
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
FATIGUE	General disorders	—	—	—	—	—	—	—	—	—	—	—
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
NEUROPATHY PERIPHERAL	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
CONSTIPATION	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
WEIGHT DECREASED	Investigations	—	—	—	—	—	—	—	—	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
DYSPEPSIA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
PYREXIA	General disorders	—	—	—	—	—	—	—	—	—	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
INSOMNIA	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—	—	—	—	—	—	—	—	—	—
PARAESTHESIA	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
OEDEMA PERIPHERAL	General disorders	—	—	—	—	—	—	—	—	—	—	—
PAIN	General disorders	—	—	—	—	—	—	—	—	—	—	—
SINUSITIS	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—	—	—
HYPERGLYCAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
HYPOKALAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—
DIZZINESS	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—
LEUKOPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—
DRY MOUTH	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—
CHILLS	General disorders	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: FEBRILE NEUTROPENIA, PNEUMONIA, PYREXIA, COVID-19 PNEUMONIA, INFUSION RELATED REACTION, ANAEMIA, NEUTROPENIA, THROMBOCYTOPENIA.

Data from ClinicalTrials.gov NCT02611323 adverse events section.

Sponsor's own description

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
2021 Update on Diffuse large B cell lymphoma: A review of current data and potential applications on risk stratification and management.
Susanibar-Adaniya S, Barta SK. · · 2021 · cited 250× · PMID 33661537 · DOI 10.1002/ajh.26151
Pathways and mechanisms of venetoclax resistance.
Bose P, Gandhi V, Konopleva M. · · 2017 · cited 223× · PMID 28140720 · DOI 10.1080/10428194.2017.1283032
BCL-2 as therapeutic target for hematological malignancies.
Perini GF, Ribeiro GN, Pinto Neto JV, Campos LT, et al · · 2018 · cited 153× · PMID 29747654 · DOI 10.1186/s13045-018-0608-2
Polatuzumab Vedotin: First Global Approval.
Deeks ED. · · 2019 · cited 151× · PMID 31352604 · DOI 10.1007/s40265-019-01175-0
A Review of Obinutuzumab (GA101), a Novel Type II Anti-CD20 Monoclonal Antibody, for the Treatment of Patients with B-Cell Malignancies.
Tobinai K, Klein C, Oya N, Fingerle-Rowson G. · · 2017 · cited 128× · PMID 28004361 · DOI 10.1007/s12325-016-0451-1
New agents and regimens for diffuse large B cell lymphoma.
Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z
The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy.
Vogler M, Braun Y, Smith VM, Westhoff MA, et al · · 2025 · cited 104× · PMID 40113751 · DOI 10.1038/s41392-025-02176-0

Verify or expand the search:

Other trials of Obinutuzumab

Trials testing the same drug.

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NCT07502872 — TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-g · Phase 2 · not yet recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal · Phase 2 · recruiting
NCT07480850 — Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma · Phase 2 · active not recruiting
NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma · Phase 2 · not yet recruiting

Other recruiting trials for Non-Hodgkin's Lymphoma

Currently open trials in the same condition.

NCT07202052 — Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT) · Phase 2, PHASE3 · recruiting
NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
NCT05884333 — Cord Blood Transplant in Adults With Blood Cancers · Phase 2 · recruiting
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Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02611323 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 10 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02611323.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02611323

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

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Related trials

Other trials of Obinutuzumab

Other recruiting trials for Non-Hodgkin's Lymphoma

Other Hoffmann-La Roche trials

Verify against primary sources