check_circleStudy Completed
Diffuse, Large B-Cell, Lymphoma
Bayer Identifier:
17119
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase II copanlisib in relapsed/refractory Diffuse large B-cell lymphoma (DLBCL)
Trial purpose
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
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
67Trial Dates
May 2015 - January 2018Phase
Phase 2Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | PARIS cedex, 75475, France | |
Completed | CRETEIL, 94010, France | |
Withdrawn | Copenhagen, 2100, Denmark | |
Completed | Odense C, 5000, Denmark | |
Completed | Aarhus C, 8000, Denmark | |
Withdrawn | Aalborg, 9100, Denmark | |
Completed | PIERRE BENITE, 69310, France | |
Completed | CAEN CEDEX, 14033, France | |
Completed | POITIERS cedex, 86021, France | |
Withdrawn | Singapore, 169608, Singapore | |
Completed | Singapore, 169610, Singapore | |
Completed | Southampton, SO16 6YD, United Kingdom | |
Completed | LILLE, 59037, France | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | LEUVEN, 3000, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | Wilrijk, 2610, Belgium | |
Completed | EDEGEM, 2650, Belgium | |
Completed | Ballarat, 3350, Australia | |
Withdrawn | Garran, 2605, Australia | |
Withdrawn | Madrid, 28033, Spain | |
Withdrawn | Majadahonda, 28222, Spain | |
Withdrawn | Salamanca, 37007, Spain | |
Withdrawn | L'Hospitalet de Llobregat, 08907, Spain | |
Completed | Kingswood, 2747, Australia | |
Completed | BOX HILL, 3128, Australia | |
Completed | Prahran, 3181, Australia | |
Withdrawn | Kayseri, 38039, Turkey | |
Withdrawn | Gaziantep, 27070, Turkey | |
Completed | Münster, 48149, Germany | |
Withdrawn | Mainz, 55131, Germany | |
Completed | Berlin, 10967, Germany | |
Completed | Leipzig, Germany | |
Withdrawn | Trabzon, 61080, Turkey | |
Withdrawn | RENNES CEDEX, 35033, France | |
Completed | London, NW1 2PG, United Kingdom | |
Completed | Truro, TR1 3LJ, United Kingdom | |
Completed | Montreal, H1T 2M4, Canada | |
Completed | Brampton, L6R 3J7, Canada | |
Withdrawn | Bologna, 40138, Italy | |
Completed | Milano, 20089, Italy | |
Withdrawn | Firenze, 50141, Italy | |
Withdrawn | Brescia, 25123, Italy | |
Withdrawn | Udine, 33100, Italy | |
Completed | Montreal, H3T 1E2, Canada | |
Completed | Sherbrooke, J1H 5N4, Canada | |
Withdrawn | Novara, 28100, Italy | |
Completed | St. John's, A1B 3V6, Canada |
Primary Outcome
- Objective response rate (ORR) in total population based on investigator assessmentThe 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.date_rangeTime 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)enhanced_encryptionNoSafety Issue:
- ORR by CD79b status based on investigator assessmentThe 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.date_rangeTime 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)enhanced_encryptionNoSafety Issue:
- ORR by DLBCL/COO subtype based on investigator assessmentThe 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.date_rangeTime 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)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Duration of response (DOR) in total populationThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- DOR by CD79b statusThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- DOR by DLBCL/COO subtypeThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- Progression-free survival (PFS) in total populationThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- PFS by CD79b statusThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- PFS by DLBCL/COO subtypeThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- Overall survival (OS) in total populationThe overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- OS by CD79b statusThe overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- OS by DLBCL/COO subtypeThe overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- Duration of stable disease (DOSD) in total populationThe 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- Disesase control rate (DCR) in total populationThe disesase 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- DCR by CD79b statusThe disesase 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- DCR by DLBCL/COO subtypeThe disesase 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.date_rangeTime 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 firstenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime 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 participantenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1