Trial · NCT02600897
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)
NCT02600897, Phase 1, Phase 2, Completed, Hoffmann-La Roche; results first posted 2023-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT02600897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02600897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT02600897
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 114 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Interventions
- Lenalidomide, Obinutuzumab, Polatuzumab Vedotin, Rituximab
- First posted
- 2015-11-09
- Last updated
- 2023-12-26
- Other registries' IDs
- eudract:2015-001999-22
- Results first posted
- 2023-12-26
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose-Limiting Toxicities (DLTs) | 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; hematologic adverse events that met a few protocol specified criteria. DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Percentages have been rounded off to the first decimal point. |
| Primary | Percentage of Participants With Adverse Events (AEs) | 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. |
| Primary | 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 | 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, immunohistochemistry (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. |
| 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 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 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 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. |
| Secondary | Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone | 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. |
| Secondary | Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans | 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 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, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages have been rounded off up to the second decimal point. |
| Secondary | Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans | 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 \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline(diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages are rounded off. |
| Secondary | Percentage of Participants With Objective Response 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 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 sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 28 days). Percentages have been rounded off to the first decimal point. |
| Secondary | Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone | 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 extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Dose-Limiting Toxicities (DLTs) | Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase | The safety-evaluable population included all participants who received at least one dose of any component of the combination. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | From study start up to end of study (Up to a maximum of 69 months) | The safety-evaluable population included all participants who received at least one dose of any component of the combination. | percentage of participants | NUMBER |
| PRIMARY | 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 | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (cycle=28 days) (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response 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 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone | 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) | Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM. 'Overall Number Analyzed'=number of participants with data available for analysis. | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group487
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 Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 0.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL | 50.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL | 0.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 0.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL | 0.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL | 0.0 | percentage of participants | ||
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) | Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 0.0 | percentage of participants | ||
| Percentage of Participants With Adverse Events (AEs) | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 100.0 | percentage of participants | ||
| Percentage of Participants With Adverse Events (AEs) | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL | 100.0 | percentage of participants | ||
| Percentage of Participants With Adverse Events (AEs) | Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL | 100.0 | percentage of participants |
1 to 10 of 487Source ClinicalTrials.gov
See all 487 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 3 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL | 4 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL | 3 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 6 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL | 3 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL | 5 | |
| Overall Study | STARTED | Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 10 | |
| Overall Study | STARTED | Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 40 | |
| Overall Study | STARTED | Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 40 | |
| Overall Study | Intent-to-Treat Population | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 3 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events2,025
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 Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 1 | 3 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL | 0 | 4 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL | 1 | 3 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 3 | 6 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL | 1 | 3 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL | 2 | 5 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 5 | 10 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 18 | 40 | 29 |
| other | ANAEMIA | Blood and lymphatic system disorders | Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 14 | 39 | 22 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 0 | 3 | 0 |
1 to 10 of 2,025Source ClinicalTrials.gov
See all 2,025 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 1 | 3 |
| Total, all-cause mortality | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL | 2 | 4 |
| Total, all-cause mortality | Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL | 1 | 3 |
| Total, all-cause mortality | Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 2 | 6 |
| Total, all-cause mortality | Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL | 3 | 3 |
| Total, all-cause mortality | Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL | 2 | 5 |
| Total, all-cause mortality | Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 10 | 10 |
| Total, all-cause mortality | Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL | 7 | 40 |
| Total, all-cause mortality | Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL | 20 | 39 |
| Total, other adverse events | Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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