A Phase 2 interventional study of Copanlisib (Aliqopa, BAY80-6946) in Diffuse, Large B-Cell, Lymphoma, sponsored by Bayer. Completed at 32 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 67 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)
Drug: Copanlisib (Aliqopa, BAY80-6946)
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
ORR by CD79b Status Based on Investigator Assessment
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
ORR by DLBCL/COO Subtype Based on Investigator Assessment
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
Duration of Response (DOR) in Total Population
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
DOR by CD79b Status
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
DOR by DLBCL/COO Subtype
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Progression-free Survival (PFS) in Total Population
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
PFS by CD79b Status
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
PFS by DLBCL/COO Subtype
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Overall Survival (OS) in Total Population
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
OS by CD79b Status
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
OS by DLBCL/COO Subtype
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Duration of Stable Disease (DOSD) in Total Population
The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Disease Control Rate (DCR) in Total Population
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
DCR by CD79b Status
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
DCR by DLBCL/COO Subtype
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.
Time frame: From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
Time to Response (TTR) in Total Population
The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. participants with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Time frame: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first
ORR in Total Population Based on Central Imaging Review
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
ORR by CD79b Status Based on Central Imaging Review
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
ORR by DLBCL/COO Subtype Based on Central Imaging Review
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Time frame: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
The study was conducted at 32 centers across 10 countries, between 08 May 2015 (first patient first visit) and 18 January 2018 (last patient last visit).
| Milestone | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Started | 67 |
| Included in per protocol set | 40 |
| Completed | 53 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Adverse event (ae) without clinical pd | 9 |
| Withdrew: Ae with clinical pd | 3 |
| Milestone | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Started | 56 |
| Completed | 43 |
| Not completed | 13 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Switching to other therapy | 4 |
| Withdrew: No follow up | 1 |
| Withdrew: Deterioration of general conditions | 3 |
| Milestone | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Started | 9 |
| Completed | 6 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Switching to other therapy | 2 |
| Milestone | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Started | 46 |
| Completed | 42 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Switching to other therapy | 1 |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
| Percentage of participants | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Full analysis set (FAS) | 19.4 (11.9 to 29.1) |
| Per protocol set (PPS) | 25.0 (14.2 to 38.7) |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
| Percentage of participants | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| Full analysis set (FAS) | 22.2 (4.1 to 55.0) | 20.0 (10.9 to 32.3) | 15.4 (2.8 to 41.0) |
| Per protocol set (PPS) | 25.0 (4.6 to 60.0) | 25.0 (13.1 to 40.6) | — |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
| Percentage of participants | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| Full analysis set (FAS) | 31.6 (14.7 to 53.0) | 13.3 (4.7 to 28.0) | 33.3 (1.7 to 86.5) | 13.3 (2.4 to 36.3) |
| Per protocol set (PPS) | 37.5 (17.8 to 60.9) | 13.6 (3.8 to 31.6) | 50.0 (2.5 to 97.5) | — |
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Duration of Response (DOR) in Total Population | 132 (57 to 345) |
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| DOR by CD79b Status | 516 (417 to 615) | 113 (39 to 272) | 113 (93 to 132) |
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| DOR by DLBCL/COO Subtype | 193 (39 to 417) | 183 (63 to 615) | 52 (NA to NA) | 113 (93 to 132) |
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Progression-free Survival (PFS) in Total Population | 54 (50 to 84) |
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| PFS by CD79b Status | 73 (43 to 465) | 52 (46 to 88) | 56 (46 to 138) |
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| PFS by DLBCL/COO Subtype | 73 (44 to 101) | 52 (46 to 116) | 84 (26 to 164) | 51 (33 to 58) |
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
| Days | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Overall Survival (OS) in Total Population | 224 (104 to 327) |
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
| Days | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| OS by CD79b Status | 178 (57 to NA) | 242 (73 to 385) | 224 (56 to 388) |
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
| Days | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| OS by DLBCL/COO Subtype | 210 (63 to 421) | 287 (94 to 436) | 164 (93 to 273) | 160 (46 to 400) |
The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Duration of Stable Disease (DOSD) in Total Population | 106 (73 to 138) |
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Percentage of participants | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Disease Control Rate (DCR) in Total Population | 40.3 (30.2 to 51.1) |
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Percentage of participants | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| DCR by CD79b Status | 55.6 (25.1 to 83.1) | 40.0 (27.7 to 53.3) | 30.8 (11.3 to 57.3) |
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Percentage of participants | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| DCR by DLBCL/COO Subtype | 52.6 (32.0 to 72.6) | 40.0 (25.0 to 56.6) | 33.3 (1.7 to 86.5) | 26.7 (9.7 to 51.1) |
A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.
| Participants | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Any TEAE | 65 |
| Any TESAE | 44 |
The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. participants with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
| Days | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Time to Response (TTR) in Total Population | 52 (49 to 56) |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
| Percentage of participants | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| ORR in Total Population Based on Central Imaging Review | 22.4 (14.3 to 32.4) |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
| Percentage of participants | CD79b Mutant | CD79b Wild-type | CD79b Status Missing |
|---|---|---|---|
| ORR by CD79b Status Based on Central Imaging Review | 44.4 (16.9 to 74.9) | 20.0 (10.9 to 32.3) | 15.4 (2.8 to 41.0) |
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
| Percentage of participants | Activated B-cell-like (ABC) | Germinal Center B-cell-like (GCB) | Unclassifiable | DLBCL/COO Subtype Missing |
|---|---|---|---|---|
| ORR by DLBCL/COO Subtype Based on Central Imaging Review | 47.4 (27.4 to 68.0) | 13.3 (4.7 to 28.0) | 0.0 (0.0 to 63.2) | 13.3 (2.4 to 36.3) |
Collected over From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Copanlisib (Aliqopa, BAY80-6946) | 53/67 (79.1%) | 44/67 (65.7%) | 64/67 (95.5%) |
| Event | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| General physical health deteriorationGeneral disorders | 9/67 |
| HyperglycaemiaMetabolism and nutrition disorders | 5/67 |
| PyrexiaGeneral disorders | 4/67 |
| Abdominal painGastrointestinal disorders | 3/67 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 3/67 |
| DeathGeneral disorders | 2/67 |
| Lung infectionInfections and infestations | 2/67 |
| Back painMusculoskeletal and connective tissue disorders | 2/67 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/67 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/67 |
| Event | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| HypertensionVascular disorders | 27/67 |
| DiarrhoeaGastrointestinal disorders | 25/67 |
| HyperglycaemiaMetabolism and nutrition disorders | 21/67 |
| NauseaGastrointestinal disorders | 20/67 |
| FatigueGeneral disorders | 18/67 |
| VomitingGastrointestinal disorders | 12/67 |
| PyrexiaGeneral disorders | 12/67 |
| CoughRespiratory, thoracic and mediastinal disorders | 12/67 |
| ConstipationGastrointestinal disorders | 11/67 |
| Decreased appetiteMetabolism and nutrition disorders | 10/67 |
| Age, Continuous(Years) | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Full analysis set (FAS) | 65.3 ± 14.5 |
| Per protocol set (PPS) | 69.2 ± 12.2 |
| Sex: Female, Male(Participants) | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Full analysis set (FAS) — Female | 28 |
| Full analysis set (FAS) — Male | 39 |
| Per protocol set (PPS) — Female | 15 |
| Per protocol set (PPS) — Male | 25 |
| CD79b Status(Participants) | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Full analysis set (FAS) — CD79b Mutant | 9 |
| Full analysis set (FAS) — CD79b Wild-type | 45 |
| Full analysis set (FAS) — CD79b Status Missing | 13 |
| Per protocol set (PPS) — CD79b Mutant | 8 |
| Per protocol set (PPS) — CD79b Wild-type | 32 |
| Per protocol set (PPS) — CD79b Status Missing | 0 |
| DLBCL / Cell of Origin (COO) Subtype(Participants) | Copanlisib (Aliqopa, BAY80-6946) |
|---|---|
| Full analysis set (FAS) — Activated B-cell-like (ABC) | 19 |
| Full analysis set (FAS) — Germinal center B-cell-like (GCB) | 30 |
| Full analysis set (FAS) — Unclassifiable | 3 |
| Full analysis set (FAS) — DLBCL/COO Subtype Missing | 15 |
| Per protocol set (PPS) — Activated B-cell-like (ABC) | 16 |
| Per protocol set (PPS) — Germinal center B-cell-like (GCB) | 22 |
| Per protocol set (PPS) — Unclassifiable | 2 |
| Per protocol set (PPS) — DLBCL/COO Subtype Missing | 0 |
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