Trial · NCT02367040
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
NCT02367040, Phase 3, Completed, Bayer; results first posted 2022-01-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL). Trials, record NCT02367040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02367040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
- NCT number
- NCT02367040
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 458 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Lymphoma,Non-Hodgkin
- Interventions
- Copanlisib (Aliqopa, BAY80-6946), Placebo, Rituximab
- First posted
- 2015-02-20
- Last updated
- 2025-10-14
- Other registries' IDs
- eudract:2013-003893-29
- Results first posted
- 2022-01-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Independent Central Review. | From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years | Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). |
| Secondary | Objective Response Rate (ORR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Objective response rate (ORR) was defined as the percentage of participants who have a best response rating over the whole duration of the study (i.e. until time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria (kindly refer to the links in the Protocol section). |
| Secondary | Complete Response Rate (CRR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Complete response rate (CRR) was defined as the percentage of participants who had a best response rating over the whole duration of the study (i.e., until the time of analysis of PFS) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of Complete Response according to the Owen Criteria (kindly refer to the links in the Protocol section). |
| Secondary | Duration of Response (DOR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Duration of response (DOR) was defined as the time (in days) from first observed tumor response Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) or Minor Response (MR) until progression or death from any cause, whichever occurred earlier according to the Owen Criteria (kindly refer to the links in the Protocol section). Only patients with response in FAS were included in the analysis. |
| Secondary | Disease Control Rate (DCR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Disease control rate was defined as the percentage of participants who had a best response rating as Complete Response (CR), Partial Response (PR) or stable disease (SD) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) as a response rating of CR, very good partial response (VGPR), PR, minor response (MR) or stable disease (SD) according to the Owen Criteria (kindly refer to the links in the Protocol section). |
| Secondary | Time to Progression (TTP) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Time to progression (TTP) was defined as the time (days) from date of randomization to date of first observed disease progression according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section). |
| Secondary | Overall Survival (OS) | From randomization up to the final analysis at 15-Nov-2024 up to 9 years | Overall survival was defined as the time (in days) from randomization until death from any cause. |
| Secondary | Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Time to deterioration in DRS-P (Disease-Related Symptoms - Physical) of at least three points was defined as the time (in days) from randomization to DRS-P decline, progression, or death due to any reason, whichever occurred earlier. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. |
| Secondary | Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | Time to improvement in DRS-P (Disease-Related Symptoms - Physical) was defined as the time (in days) from randomization to DRS-P improvement of at least three points. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date. | Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date | Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Based on Independent Central Review. | From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years | All randomized participants (FAS=full analysis set) were included. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization up to the final analysis at 15-Nov-2024 up to 9 years | All randomized patients (FAS) were included. | Months | MEDIAN |
| SECONDARY | Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Months | MEDIAN |
| SECONDARY | Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire. | From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years | All randomized participants (FAS) were included. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date. | Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date | Participants in safety analysis set (SAF) with evaluable data reported. | Participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Based on Independent Central Review. | Copanlisib + Rituximab | At data cut-off=31-Aug-2020 | 21.5 | 95% Confidence Interval 17.8 to 33.0 | Months |
| Progression Free Survival (PFS) Based on Independent Central Review. | Placebo + Rituximab | At data cut-off=31-Aug-2020 | 13.8 | 95% Confidence Interval 10.2 to 17.5 | Months |
| Progression Free Survival (PFS) Based on Independent Central Review. | Copanlisib + Rituximab | At data cut-off=31-Aug-2022 | 23.2 | 95% Confidence Interval 19.4 to 33.0 | Months |
| Progression Free Survival (PFS) Based on Independent Central Review. | Placebo + Rituximab | At data cut-off=31-Aug-2022 | 13.8 | 95% Confidence Interval 10.8 to 17.5 | Months |
| Progression Free Survival (PFS) Based on Independent Central Review. | Copanlisib + Rituximab | At data cut-off=15-Nov-2024 | 22.4 | 95% Confidence Interval 19.7 to 30.7 | Months |
| Progression Free Survival (PFS) Based on Independent Central Review. | Placebo + Rituximab | At data cut-off=15-Nov-2024 | 14.0 | 95% Confidence Interval 11.4 to 19.2 | Months |
| Objective Response Rate (ORR) | Copanlisib + Rituximab | At data cut-off=31-Aug-2020 | 80.8 | Percentage of participants | |
| Objective Response Rate (ORR) | Placebo + Rituximab | At data cut-off=31-Aug-2020 | 47.7 | Percentage of participants | |
| Objective Response Rate (ORR) | Copanlisib + Rituximab | At data cut-off=31-Aug-2022 | 80.5 | Percentage of participants | |
| Objective Response Rate (ORR) | Placebo + Rituximab | At data cut-off=31-Aug-2022 | 49.7 | Percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Copanlisib + Rituximab | 307 | |
| Overall Study | STARTED | Placebo + Rituximab | 151 | |
| Overall Study | Received Treatment | Copanlisib + Rituximab | 304 | |
| Overall Study | Received Treatment | Placebo + Rituximab | 149 | |
| Overall Study | COMPLETED | Copanlisib + Rituximab | 0 | |
| Overall Study | COMPLETED | Placebo + Rituximab | 4 | |
| Overall Study | NOT COMPLETED | Copanlisib + Rituximab | 307 | |
| Overall Study | NOT COMPLETED | Placebo + Rituximab | 147 |
Source ClinicalTrials.gov
Adverse events384
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 | Copanlisib + Rituximab | 60 | 307 | 139 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Rituximab | 16 | 146 | 62 |
| other | Neutropenia | Blood and lymphatic system disorders | Copanlisib + Rituximab | 64 | 307 | 249 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Rituximab | 24 | 146 | 57 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Copanlisib + Rituximab | 13 | 307 | 32 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Rituximab | 8 | 146 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Copanlisib + Rituximab | 17 | 307 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Rituximab | 6 | 146 | 7 |
| other | Constipation | Gastrointestinal disorders | Copanlisib + Rituximab | 31 | 307 | 37 |
| other | Constipation | Gastrointestinal disorders | Placebo + Rituximab | 12 | 146 | 14 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Copanlisib + Rituximab | 99 | 307 |
| Total, all-cause mortality | Placebo + Rituximab | 50 | 146 |
| Total, other adverse events | Copanlisib + Rituximab | 298 | 307 |
| Total, other adverse events | Placebo + Rituximab | 127 | 146 |
| Total, serious adverse events | Copanlisib + Rituximab | 161 | 307 |
| Total, serious adverse events | Placebo + Rituximab | 32 | 146 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Copanlisib + Rituximab vs Placebo + Rituximab: deaths from any cause | Trial comparisons |
| Copanlisib + Rituximab vs Placebo + Rituximab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02367040
GET https://conductscience.org/api/trials/v1/NCT02367040/results?page=2