Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.
2 other identifiers
interventional
67
10 countries
32
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2015
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedStudy Start
First participant enrolled
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2016
CompletedResults Posted
Study results publicly available
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2018
CompletedJanuary 4, 2019
December 1, 2018
1.2 years
February 16, 2015
October 13, 2017
December 10, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
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)
Secondary Outcomes (14)
Duration of Response (DOR) in Total Population
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
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
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
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
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
- +9 more secondary outcomes
Other Outcomes (4)
Time to Response (TTR) in Total Population
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
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
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)
- +1 more other outcomes
Study Arms (1)
Copanlisib (Aliqopa, BAY80-6946)
EXPERIMENTALCopanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)
Interventions
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
Eligibility Criteria
You may qualify if:
- Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
- Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
- Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
- Patients must have measurable disease.
- Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy (HDC) and stem cell transplant (SCT).
- A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
- Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
- Adequate bone marrow, liver and renal function.
You may not qualify if:
- Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
- Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
- Current central nervous system (CNS) involvement by lymphoma.
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
- Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
- Type I or II diabetes mellitus with HbA1c \> 8.5% at Screening.
- New York Heart Association (NYHA) class III or IV heart disease.
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
- Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (32)
Unknown Facility
Kingswood, New South Wales, 2747, Australia
Unknown Facility
Ballarat, Victoria, 3350, Australia
Unknown Facility
Prahran, Victoria, 3181, Australia
Unknown Facility
Box Hill, 3128, Australia
Unknown Facility
Wilrijk, Antwerpen, 2610, Belgium
Unknown Facility
Bruxelles - Brussel, 1200, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Unknown Facility
Brampton, Ontario, L6R 3J7, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 5N4, Canada
Unknown Facility
Aarhus C, 8000, Denmark
Unknown Facility
Odense C, 5000, Denmark
Unknown Facility
Caen, 14033, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Pierre-Bénite, 69310, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Münster, North Rhine-Westphalia, 48149, Germany
Unknown Facility
Leipzig, Saxony, Germany
Unknown Facility
Berlin, 10967, Germany
Unknown Facility
Milan, Lombardy, 20089, Italy
Unknown Facility
Singapore, 169610, Singapore
Unknown Facility
Seoul, 05505, South Korea
Unknown Facility
Seoul, 110-744, South Korea
Unknown Facility
Truro, Cornwall, TR1 3LJ, United Kingdom
Unknown Facility
Southampton, Hampshire, SO16 6YD, United Kingdom
Unknown Facility
London, NW1 2PG, United Kingdom
Related Publications (1)
Lenz G, Hawkes E, Verhoef G, Haioun C, Thye Lim S, Seog Heo D, Ardeshna K, Chong G, Haaber J, Shi W, Gorbatchevsky I, Lippert S, Hiemeyer F, Piraino P, Beckmann G, Pena C, Buvaylo V, Childs BH, Salles G. Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma. Leukemia. 2020 Aug;34(8):2184-2197. doi: 10.1038/s41375-020-0743-y. Epub 2020 Feb 14.
PMID: 32060403DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2015
First Posted
March 18, 2015
Study Start
May 8, 2015
Primary Completion
July 5, 2016
Study Completion
January 19, 2018
Last Updated
January 4, 2019
Results First Posted
January 8, 2018
Record last verified: 2018-12