check_circleStudy Completed

Diffuse, Large B-Cell, Lymphoma

Bayer Identifier:

17119

ClinicalTrials.gov Identifier:

NCT02391116

EudraCT Number:

2014-004848-36

EU CT Number:

Not Available
Phase II copanlisib in relapsed/refractory Diffuse large B-cell lymphoma (DLBCL)

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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
May 2015 - January 2018
Phase
Phase 2
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
PARIS cedex, 75475, France
Completed
CRETEIL, 94010, France
Withdrawn
Copenhagen, 2100, Denmark
Completed
Odense C, 5000, Denmark
Completed
Aarhus C, 8000, Denmark
Withdrawn
Aalborg, 9100, Denmark
Completed
PIERRE BENITE, 69310, France
Completed
CAEN CEDEX, 14033, France
Completed
POITIERS cedex, 86021, France
Withdrawn
Singapore, 169608, Singapore
Completed
Singapore, 169610, Singapore
Completed
Southampton, SO16 6YD, United Kingdom
Completed
LILLE, 59037, France
Completed
Seoul, 110-744, Korea, Republic Of
Completed
Seoul, 05505, Korea, Republic Of
Completed
LEUVEN, 3000, Belgium
Completed
GENT, 9000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
Wilrijk, 2610, Belgium
Completed
EDEGEM, 2650, Belgium
Completed
Ballarat, 3350, Australia
Withdrawn
Garran, 2605, Australia
Withdrawn
Madrid, 28033, Spain
Withdrawn
Majadahonda, 28222, Spain
Withdrawn
Salamanca, 37007, Spain
Withdrawn
L'Hospitalet de Llobregat, 08907, Spain
Completed
Kingswood, 2747, Australia
Completed
BOX HILL, 3128, Australia
Completed
Prahran, 3181, Australia
Withdrawn
Kayseri, 38039, Turkey
Withdrawn
Gaziantep, 27070, Turkey
Completed
Münster, 48149, Germany
Withdrawn
Mainz, 55131, Germany
Completed
Berlin, 10967, Germany
Completed
Leipzig, Germany
Withdrawn
Trabzon, 61080, Turkey
Withdrawn
RENNES CEDEX, 35033, France
Completed
London, NW1 2PG, United Kingdom
Completed
Truro, TR1 3LJ, United Kingdom
Completed
Montreal, H1T 2M4, Canada
Completed
Brampton, L6R 3J7, Canada
Withdrawn
Bologna, 40138, Italy
Completed
Milano, 20089, Italy
Withdrawn
Firenze, 50141, Italy
Withdrawn
Brescia, 25123, Italy
Withdrawn
Udine, 33100, Italy
Completed
Montreal, H3T 1E2, Canada
Completed
Sherbrooke, J1H 5N4, Canada
Withdrawn
Novara, 28100, Italy
Completed
St. John's, A1B 3V6, Canada

Primary Outcome

  • 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.
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Disesase control rate (DCR) in total population
    The 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • DCR by CD79b status
    The 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • DCR by DLBCL/COO subtype
    The 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    Yes

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

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