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

NCT ID: NCT02391116

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-08
• Study Completion Date: 2018-01-19

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

Conditions

Diffuse, Large B-Cell, Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Copanlisib (Aliqopa, BAY80-6946)

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

Group Type: EXPERIMENTAL

Copanlisib (Aliqopa, BAY80-6946)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kingswood, New South Wales, Australia

Ballarat, Victoria, Australia

Prahran, Victoria, Australia

Box Hill, , Australia

Wilrijk, Antwerpen, Belgium

Bruxelles - Brussel, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Leuven, , Belgium

St. John's, Newfoundland and Labrador, Canada

Brampton, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Aarhus C, , Denmark

Odense C, , Denmark

Caen, , France

Créteil, , France

Lille, , France

Paris, , France

Pierre-Bénite, , France

Poitiers, , France

Münster, North Rhine-Westphalia, Germany

Leipzig, Saxony, Germany

Berlin, , Germany

Milan, Lombardy, Italy

Singapore, , Singapore

Seoul, , South Korea

Seoul, , South Korea

Truro, Cornwall, United Kingdom

Southampton, Hampshire, United Kingdom

London, , United Kingdom

Countries

Australia; Belgium; Canada; Denmark; France; Germany; Italy; Singapore; South Korea; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32060403 (View on PubMed)

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

2014-004848-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17119

Identifier Type: -

Identifier Source: org_study_id