Who is sponsoring NCT02600897?

NCT02600897 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT02600897?

Interventions in NCT02600897: Lenalidomide, Obinutuzumab, Polatuzumab Vedotin, Rituximab.

Is NCT02600897 still recruiting?

NCT02600897 is currently completed. Last updated 26 December 2023.

Are results published for NCT02600897?

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

Last reviewed 2023-12-26 · How we verify

NCT02600897

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

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

Completed Phase 1, PHASE2 Results posted Last updated 26 December 2023

What this trial tests

Phase 1, PHASE2 trial testing Lenalidomide in Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma in 114 participants. Completed in 15 December 2021.

Timeline

24 March 2016

Primary endpoint
15 December 2021

15 December 2021

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	114
Start date	24 March 2016
Primary completion	15 December 2021
Estimated completion	15 December 2021
Sites	28 locations across United Kingdom, United States, Spain

Drugs / interventions tested

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

Conditions studied

Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma — all drugs for Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell 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 Dose-Limiting Toxicities (DLTs) Primary · Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase

A DLT was defined as any one of the following toxicities occurring during the first cycle of treatment and assessed by the investigator as related to study treatment: Any adverse event of any grade that lead to a delay of \> 14 days in the start of the next treatment cycle, Grade 3 or 4 non-hematologic adverse events with few exceptions; increase in hepatic transaminase \> 3 x baseline and an increase in direct bilirubin \> 2 x upper limits of normal (ULN), without any findings of cholestasis or jaundice, or signs of hepatic dysfunction, and in the absence of other contributory factors; hemato

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	0.0
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	50.0
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	0.0
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	0.0
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	0.0
Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL	0.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	0.0

Percentage of Participants With Adverse Events (AEs) Primary · From study start up to end of study (Up to a maximum of 69 months)

An AE 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 AE 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. Percentages have been rounded off to the first decimal point.

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	100.0
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	100.0
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	100.0
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL	100.0
Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL	100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	100.0
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	97.4

Percentage of Participants With Complete Response (CR) at End of Induction (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 28 weeks)

CR at EOI was assessed by IRC according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (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 fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immun

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	66.7	27.13 – 93.72
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	0.0	0.0 – 25.89
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	60.0	45.78 – 73.06
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	38.5	25.41 – 52.89

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 28 weeks)

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. Bone marrow is normal by morphology; if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	66.7	27.13 – 93.72
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	0.0	0.0 – 25.89
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	60.0	45.78 – 73.06
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	33.3	20.97 – 47.69

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 28 weeks)

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 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, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	16.7	0.85 – 58.18
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	0.0	0.0 – 31.23
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	31.4	18.73 – 46.61
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	12.5	4.38 – 26.36

Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone Secondary · 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

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. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	16.7	0.85 – 58.18
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	0.0	0.0 – 28.31
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	29.7	17.65 – 44.38
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	28.1	15.53 – 43.94

Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans Secondary · 6 to 8 weeks after Day 1 of Cycle 6 (cycle=28 days) (up to approximately 28 weeks)

OR was defined as percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT is 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.Bone marrow is normal by morphology; if indeterminate, IHC negative. Partial response (PR) based on PET-CT was defined as par

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0	60.70 – 100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	10.0	0.51 – 39.42
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	72.50	58.61 – 83.75
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	46.20	32.35 – 60.42

Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans Secondary · 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

OR was defined percentage of participants with CR or PR assessed by the investigator according to MLRC. Per MLRC CR based on PET-CT is complete MR in lymph nodes \& ELS with score of 1, 2, 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.Bone marrow is normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0	60.70 – 100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	10.0	0.51 – 39.42
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	80.0	66.80 – 89.64
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	46.20	32.35 – 60.42

Percentage of Participants With Objective Response 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 28 weeks)

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
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0	60.70 – 100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	12.5	0.64 – 47.07
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	91.4	79.31 – 97.62
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	53.1	37.34 – 68.46

Percentage of Participants With Objective Response, 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 28 weeks)

OR was defined as the percentage of participants with CR or PR, as assessed by the investigator 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 ex

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0	60.70 – 100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	11.1	0.57 – 42.91
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	89.2	76.95 – 96.22
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	59.4	43.35 – 74.03

Percentage of Participants With Best Response of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone Secondary · Up to every 6 months until disease progression, unacceptable toxicity or study completion (up to approximately 69 months)

BOR=CR/PR per CT per MLRC. Per MLRC, CR based on CT was defined as a 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 SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond n

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	100.0	60.70 – 100.0
Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	50.0	22.24 – 77.76
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	90.0	78.56 – 96.51
Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL	79.5	66.02 – 89.36

Observed Serum Obinutuzumab Concentration Secondary · Day 1 of Cycles 1, 2, 4 & 6: predose & 30 mins postdose; EOI: predose; Day 1 of Maintenance Months 1,7, 13, 19;Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months)

1 cycle = 28 days

Induction Cycle 1 Day 1 / Predose

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	NA	± NA
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	NA	± NA
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	NA	± NA
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	NA	± NA
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	NA	± NA

Induction Cycle 1 Day 1 / 30 mins

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	394	± 22.1
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	358	± 20.5
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	351	± 15.2
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	333	± 70.0
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	182	± 206.7

Induction Cycle 2 Day 1 / Predose

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	451	± 23.5
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	372	± 37.0
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	386	± 4.6
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	481	± 23.1
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	312	± 40.8

Induction Cycle 2 Day 1 / 30 mins

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	830	± 38.3
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	749	± 17.2
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	695	± 14.3
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	667	± 77.5
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	588	± 41.4

Induction Cycle 4 Day 1 / Predose

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	354	± 15.0
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	321	± 43.6
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	344	± 13.4
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	405	± 24.9
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	270	± 41.8

Induction Cycle 4 Day 1 / 30 mins

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	103	± NA
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	644	± 42.8
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	653	± 20.6
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	742	± 27.8
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	547	± 37.1

Induction Cycle 6 Day 1 / Predose

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	255	± 36.6
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	504	± NA
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	327	± 5.8
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	384	± 52.2
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	255	± 49.0

Induction Cycle 6 Day 1 / 30 mins

Group	Value	95% CI
Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL	730	± 15.5
Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL	804	± NA
Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL	1.18	± NA
Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	751	± 35.3
Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL	543	± 36.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to study completion/discontinuation (maximum of 69 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL

Serious: 3/3 (100%)

Deaths: 1/3

Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Serious: 2/4 (50%)

Deaths: 2/4

Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL

Serious: 2/3 (67%)

Deaths: 1/3

Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Serious: 3/6 (50%)

Deaths: 2/6

Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL

Serious: 0/3 (0%)

Deaths: 3/3

Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL

Serious: 0/5 (0%)

Deaths: 2/5

Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL

Serious: 4/10 (40%)

Deaths: 10/10

Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Serious: 26/40 (65%)

Deaths: 7/40

Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL

Serious: 19/39 (49%)

Deaths: 20/39

Serious adverse events (62 terms)

Reaction	System	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.8…	Expansion Phase: 1.4 mg Po…	Expansion Phase: 1.8 mg Po…
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—	—
PYREXIA	General disorders	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—
NEUTROPENIC SEPSIS	Infections and infestations	—	—	—	—	—	—	—	—	—
RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
ACUTE CORONARY SYNDROME	Cardiac disorders	—	—	—	—	—	—	—	—	—
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	—	—	—	—	—	—	—	—	—
CARDIAC FAILURE	Cardiac disorders	—	—	—	—	—	—	—	—	—
PERICARDITIS	Cardiac disorders	—	—	—	—	—	—	—	—	—
HYPOTHYROIDISM	Endocrine disorders	—	—	—	—	—	—	—	—	—
VISION BLURRED	Eye disorders	—	—	—	—	—	—	—	—	—
COLITIS	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
LIP SWELLING	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
BRONCHIOLITIS	Infections and infestations	—	—	—	—	—	—	—	—	—
CELLULITIS	Infections and infestations	—	—	—	—	—	—	—	—	—
COVID-19 PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—	—
EPIDIDYMITIS	Infections and infestations	—	—	—	—	—	—	—	—	—
INJECTION SITE INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—

Other adverse events (163 terms — click to expand)

Reaction	System	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.4…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.8…	Dose-escalation Phase: 1.8…	Expansion Phase: 1.4 mg Po…	Expansion Phase: 1.8 mg Po…
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
PYREXIA	General disorders	—	—	—	—	—	—	—	—	—
FATIGUE	General disorders	—	—	—	—	—	—	—	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
CONSTIPATION	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
NASOPHARYNGITIS	Infections and infestations	—	—	—	—	—	—	—	—	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
ASTHENIA	General disorders	—	—	—	—	—	—	—	—	—
RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
BLOOD CREATININE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
DIZZINESS	Nervous system disorders	—	—	—	—	—	—	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—	—	—	—	—	—	—	—
OEDEMA PERIPHERAL	General disorders	—	—	—	—	—	—	—	—	—
PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—	—
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	—	—	—	—	—	—	—	—	—
HYPERGLYCAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
HYPOCALCAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
HYPOKALAEMIA	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
PARAESTHESIA	Nervous system disorders	—	—	—	—	—	—	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: FEBRILE NEUTROPENIA, PNEUMONIA, PYREXIA, COVID-19, LOWER RESPIRATORY TRACT INFECTION, NEUTROPENIC SEPSIS, RESPIRATORY TRACT INFECTION, TUMOUR LYSIS SYNDROME.

Data from ClinicalTrials.gov NCT02600897 adverse events section.

Sponsor's own description

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment with obinutuzumab in combination with lenalidomide in participants with FL who achieve a complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.

Publications & conference data

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

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
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
Polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas.
Liebers N, Duell J, Fitzgerald D, Kerkhoff A, et al · · 2021 · cited 71× · PMID 34196677 · DOI 10.1182/bloodadvances.2020004155
Antibody-drug conjugates for the treatment of lymphoma: clinical advances and latest progress.
Chu Y, Zhou X, Wang X. · · 2021 · cited 48× · PMID 34090506 · DOI 10.1186/s13045-021-01097-z
Current Status of Marine-Derived Compounds as Warheads in Anti-Tumor Drug Candidates.
Newman DJ, Cragg GM. · · 2017 · cited 43× · PMID 28353637 · DOI 10.3390/md15040099
Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies.
Sawalha Y. · · 2021 · cited 25× · PMID 34945817 · DOI 10.3390/jpm11121345
Antibody-drug conjugates for lymphoma patients: preclinical and clinical evidences.
Barreca M, Lang N, Tarantelli C, Spriano F, et al · · 2022 · cited 23× · PMID 36654819 · DOI 10.37349/etat.2022.00112

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07247097 — ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred · Phase 2 · not yet recruiting
NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in · active not recruiting
NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma · Phase 2 · not yet recruiting
NCT06910124 — Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Neg · Phase 2 · recruiting

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 NCT02600897 (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: 26 December 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/NCT02600897.

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