Trial · NCT02626455
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
NCT02626455, Phase 3, Terminated, Bayer; results first posted 2024-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL). Trials, record NCT02626455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02626455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
- NCT number
- NCT02626455
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 551 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Copanlisib (BAY80-6946), Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Bendamustine, Prednisone
- First posted
- 2015-12-10
- Last updated
- 2024-12-11
- Other registries' IDs
- eudract:2015-001088-38
- Results first posted
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SRI: Occurrence of Dose-limiting Toxicities (DLT) | At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP | Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting \>7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3. |
| Primary | Phase 3: Progression-free Survival (PFS) by Independent Central Review | Approximately 6 years 4 months | PFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented). |
| Secondary | SRI: Best Overall Response | Approximately 7 years 8 months | Best overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first. |
| Secondary | SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE) | Approximately 4 years 10 months | A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake. |
| Secondary | Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review | Up to 6 years 4 months | ORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS). |
| Secondary | Phase 3: ORR-Investigator Assessment | Up to 6 years 4 months | ORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS). |
| Secondary | Phase 3: Duration of Tumor Response (DOR)-Independent Central Review | Approximately 6 years 4 months | DOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR. |
| Secondary | Phase 3: DOR-Investigator Assessment | Approximately 6 years 4 months | DOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR. |
| Secondary | Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review | Approximately 6 years 4 months | CRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS). |
| Secondary | Phase 3: CRR-Investigator Assessment | Approximately 6 years 4 months | CRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SRI: Occurrence of Dose-limiting Toxicities (DLT) | At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP | Percentage | NUMBER | |
| PRIMARY | Phase 3: Progression-free Survival (PFS) by Independent Central Review | Approximately 6 years 4 months | Months | MEDIAN | |
| SECONDARY | SRI: Best Overall Response | Approximately 7 years 8 months | Percentage | NUMBER | |
| SECONDARY | SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE) | Approximately 4 years 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review | Up to 6 years 4 months | Percentage | NUMBER | |
| SECONDARY | Phase 3: ORR-Investigator Assessment | Up to 6 years 4 months | Percentage | NUMBER | |
| SECONDARY | Phase 3: Duration of Tumor Response (DOR)-Independent Central Review | Approximately 6 years 4 months | Months | MEDIAN | |
| SECONDARY | Phase 3: DOR-Investigator Assessment | Approximately 6 years 4 months | Months | MEDIAN | |
| SECONDARY | Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review | Approximately 6 years 4 months | Percentage | NUMBER | |
| SECONDARY | Phase 3: CRR-Investigator Assessment | Approximately 6 years 4 months | Percentage | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SRI: Occurrence of Dose-limiting Toxicities (DLT) | SRI: Copa+R-B 45 mg | 0 | Percentage | ||
| SRI: Occurrence of Dose-limiting Toxicities (DLT) | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 0 | Percentage | ||
| SRI: Occurrence of Dose-limiting Toxicities (DLT) | SRI: Copa+R-CHOP 45 mg | 0 | Percentage | ||
| SRI: Occurrence of Dose-limiting Toxicities (DLT) | SRI: Copa+R-CHOP 60 mg | 0 | Percentage | ||
| SRI: Occurrence of Dose-limiting Toxicities (DLT) | SRI: Japan Copa+R-B 60 mg | 16.7 | Percentage | ||
| Phase 3: Progression-free Survival (PFS) by Independent Central Review | Phase 3: Copa+R-B/R-CHOP | 32.9 | 95% Confidence Interval 24.4 to 38.6 | Months | |
| Phase 3: Progression-free Survival (PFS) by Independent Central Review | Phase 3: Pbo+R-B/R-CHOP | 33.3 | 95% Confidence Interval 27.8 to 42.8 | Months | |
| SRI: Best Overall Response | SRI: Copa+R-B 45 mg | Best response (BR) -Complete response (CR) | 33.3 | 95% Confidence Interval 0.8 | Percentage |
| SRI: Best Overall Response | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | Best response (BR) -Complete response (CR) | 71.4 | 95% Confidence Interval 29.0 | Percentage |
| SRI: Best Overall Response | SRI: Copa+R-CHOP 45 mg | Best response (BR) -Complete response (CR) | 60.0 | 95% Confidence Interval 14.7 | Percentage |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SRI: Copa+R-B 45 mg | 3 | |
| Overall Study | STARTED | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 7 | |
| Overall Study | STARTED | SRI: Copa+R-CHOP 45 mg | 5 | |
| Overall Study | STARTED | SRI: Copa+R-CHOP 60 mg | 6 | |
| Overall Study | STARTED | SRI: Japan Copa+R-B 60 mg | 6 | |
| Overall Study | STARTED | Phase 3: Copa+R-B/R-CHOP | 262 | |
| Overall Study | STARTED | Phase 3: Pbo+R-B/R-CHOP | 262 | |
| Overall Study | COMPLETED | SRI: Copa+R-B 45 mg | 0 | |
| Overall Study | COMPLETED | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 2 | |
| Overall Study | COMPLETED | SRI: Copa+R-CHOP 45 mg | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events2,170
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 | SRI: Copa+R-B 45 mg | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 3 | 7 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | SRI: Copa+R-CHOP 45 mg | 2 | 5 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | SRI: Copa+R-CHOP 60 mg | 3 | 6 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | SRI: Japan Copa+R-B 60 mg | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: Copa+R-B/R-CHOP | 85 | 263 | 166 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: Pbo+R-B/R-CHOP | 64 | 257 | 147 |
| other | Eosinophilia | Blood and lymphatic system disorders | SRI: Copa+R-B 45 mg | 1 | 3 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 0 | 7 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | SRI: Copa+R-CHOP 45 mg | 0 | 5 | 0 |
1 to 10 of 2,170Source ClinicalTrials.gov
See all 2,170 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SRI: Copa+R-B 45 mg | 1 | 3 |
| Total, all-cause mortality | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 0 | 7 |
| Total, all-cause mortality | SRI: Copa+R-CHOP 45 mg | 0 | 5 |
| Total, all-cause mortality | SRI: Copa+R-CHOP 60 mg | 1 | 6 |
| Total, all-cause mortality | SRI: Japan Copa+R-B 60 mg | 0 | 6 |
| Total, all-cause mortality | Phase 3: Copa+R-B/R-CHOP | 68 | 263 |
| Total, all-cause mortality | Phase 3: Pbo+R-B/R-CHOP | 62 | 257 |
| Total, other adverse events | SRI: Copa+R-B 45 mg | 3 | 3 |
| Total, other adverse events | SRI: Copa+R-B 60 mg (Excluding Subjects From Japan) | 7 | 7 |
| Total, other adverse events | SRI: Copa+R-CHOP 45 mg | 5 | 5 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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.
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/NCT02626455
GET https://conductscience.org/api/trials/v1/NCT02626455/results?page=2