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Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Primary Purpose

Diffuse, Large B-Cell, Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Copanlisib (Aliqopa, BAY80-6946)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Copanlisib (Aliqopa, BAY80-6946)

Arm Description

Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 16, 2015
Last Updated
December 10, 2018
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02391116
Brief Title
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 8, 2015 (Actual)
Primary Completion Date
July 5, 2016 (Actual)
Study Completion Date
January 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse, Large B-Cell, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Copanlisib (Aliqopa, BAY80-6946)
Arm Type
Experimental
Arm Description
Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)
Intervention Type
Drug
Intervention Name(s)
Copanlisib (Aliqopa, BAY80-6946)
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
Description
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)
Title
ORR by CD79b Status Based on Investigator Assessment
Description
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)
Title
ORR by DLBCL/COO Subtype Based on Investigator Assessment
Description
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)
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) in Total Population
Description
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
Title
DOR by CD79b Status
Description
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
Title
DOR by DLBCL/COO Subtype
Description
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
Title
Progression-free Survival (PFS) in Total Population
Description
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
Title
PFS by CD79b Status
Description
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
Title
PFS by DLBCL/COO Subtype
Description
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
Title
Overall Survival (OS) in Total Population
Description
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
Title
OS by CD79b Status
Description
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
Title
OS by DLBCL/COO Subtype
Description
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
Title
Duration of Stable Disease (DOSD) in Total Population
Description
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
Title
Disease Control Rate (DCR) in Total Population
Description
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
Title
DCR by CD79b Status
Description
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
Title
DCR by DLBCL/COO Subtype
Description
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
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
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
Other Pre-specified Outcome Measures:
Title
Time to Response (TTR) in Total Population
Description
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
Title
ORR in Total Population Based on Central Imaging Review
Description
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)
Title
ORR by CD79b Status Based on Central Imaging Review
Description
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)
Title
ORR by DLBCL/COO Subtype Based on Central Imaging Review
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
PARIS cedex
ZIP/Postal Code
75475
Country
France
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
City
POITIERS cedex
ZIP/Postal Code
86021
Country
France
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Leipzig
State/Province
Sachsen
Country
Germany
City
Berlin
ZIP/Postal Code
10967
Country
Germany
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32060403
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.

Learn more about this trial

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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