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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site PARIS cedex, France, 75475 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site CRETEIL, France, 94010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Odense C, Denmark, 5000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Aarhus C, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site PIERRE BENITE, France, 69310 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site CAEN CEDEX, France, 14033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site POITIERS cedex, France, 86021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Southampton, United Kingdom, SO16 6YD | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Wilrijk, Belgium, 2610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ballarat, Australia, 3350 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kingswood, Australia, 2747 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site BOX HILL, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Berlin, Germany, 10967 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Leipzig, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site London, United Kingdom, NW1 2PG | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Truro, United Kingdom, TR1 3LJ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Brampton, Canada, L6R 3J7 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sherbrooke, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St. John's, Canada, A1B 3V6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
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.Timeframe: 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 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.Timeframe: 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 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.Timeframe: 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
- 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.Timeframe: 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 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.Timeframe: 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 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.Timeframe: 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 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.Timeframe: 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 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.Timeframe: 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 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.Timeframe: 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
- 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.Timeframe: 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
- OS by CD79b statusThe overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.Timeframe: 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
- 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.Timeframe: 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
- 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.Timeframe: 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
- 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.Timeframe: 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
- 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.Timeframe: 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
- 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.Timeframe: 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
- 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.Timeframe: 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
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