Trial Condition(s):

Diffuse, Large B-Cell, Lymphoma

Phase II copanlisib in relapsed/refractory Diffuse large B-cell lymphoma (DLBCL)

Bayer Identifier:

17119

ClinicalTrials.gov Identifier:

NCT02391116

EudraCT Number:

2014-004848-36

Study Completed

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

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.

Trial Summary

Enrollment Goal
67
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

PARIS cedex, France, 75475

Status
Completed
 
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Investigative Site

CRETEIL, France, 94010

Status
Completed
 
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Investigative Site

Odense C, Denmark, 5000

Status
Completed
 
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Investigative Site

Aarhus C, Denmark, 8000

Status
Completed
 
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Investigative Site

PIERRE BENITE, France, 69310

Status
Completed
 
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Investigative Site

CAEN CEDEX, France, 14033

Status
Completed
 
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Investigative Site

POITIERS cedex, France, 86021

Status
Completed
 
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Investigative Site

Singapore, Singapore, 169610

Status
Completed
 
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Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
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Investigative Site

LILLE, France, 59037

Status
Completed
 
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Investigative Site

Seoul, South Korea, 110-744

Status
Completed
 
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Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
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Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
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Investigative Site

GENT, Belgium, 9000

Status
Completed
 
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
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Investigative Site

Wilrijk, Belgium, 2610

Status
Completed
 
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Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
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Investigative Site

Ballarat, Australia, 3350

Status
Completed
 
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Investigative Site

Kingswood, Australia, 2747

Status
Completed
 
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Investigative Site

BOX HILL, Australia, 3128

Status
Completed
 
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Investigative Site

Prahran, Australia, 3181

Status
Completed
 
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Investigative Site

Münster, Germany, 48149

Status
Completed
 
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Investigative Site

Berlin, Germany, 10967

Status
Completed
 
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Leipzig, Germany

Status
Completed
 
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London, United Kingdom, NW1 2PG

Status
Completed
 
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Investigative Site

Truro, United Kingdom, TR1 3LJ

Status
Completed
 
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Investigative Site

Montreal, Canada, H1T 2M4

Status
Completed
 
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Investigative Site

Brampton, Canada, L6R 3J7

Status
Completed
 
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Investigative Site

Milano, Italy, 20089

Status
Completed
 
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Investigative Site

Montreal, Canada, H3T 1E2

Status
Completed
 
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Investigative Site

Sherbrooke, Canada, J1H 5N4

Status
Completed
 
Locations

Investigative Site

St. John's, Canada, A1B 3V6

Status
Completed
 

Trial Design