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Phase III Copanlisib in Rituximab-refractory iNHL

Phase 3
Completed
Conditions
Lymphoma, Non-Hodgkin
Interventions
Registration Number
NCT02369016
Lead Sponsor
Bayer
Brief Summary

To assess the safety of copanlisib.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
Inclusion Criteria
  • Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:

    • Follicular lymphoma (FL) grade 1-2-3a.
    • Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10*9/L at the time of diagnosis and at study entry.
    • Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
    • Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal).
  • Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.

  • Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.

  • Patients must be refractory to the last rituximab-based treatment, defined as no response or response lasting < 6 months after completion of treatment. Time interval to assess refractoriness will be calculated between the end date (last day) of the last rituximab-containing regimen and the day of diagnosis confirmation of the subsequent relapse.

  • Patients must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.

  • Patients affected by WM, who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment, must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal (ULN)and positive immunofixation test.

  • ECOG performance status ≤ 1

  • Adequate bone marrow, liver and renal function

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Exclusion Criteria
  • Histologically confirmed diagnosis of FL grade 3b.

  • Chronic lymphocytic leukemia (CLL).

  • Transformed disease (assessed by investigator):

    • histological confirmation of transformation, or
    • clinical and laboratory signs: rapid disease progression, high standardized uptake value (SUV) (> 12) by positron emission tomography (PET) at baseline if PET scans are performed (optional).
  • Bulky disease - Lymph nodes or tumor mass (except spleen) >= 7cm LD (longest diameter)

  • Known lymphomatous involvement of the central nervous system.

  • Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment).

  • Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.

  • Known history of human immunodeficiency virus (HIV) infection.

  • Active clinically serious infections > CTCAE Grade 2

  • Active Hepatitis B or hepatitis C

  • History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)

  • History of having received an allogeneic bone marrow or organ transplant

  • Positive cytomegalovirus (CMV) PCR test at baseline

  • Pregnant or breast-feeding patients

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Copanlisib (BAY 80-6946)Copanlisib (BAY 80-6946)patients with rituximab-refractory iNHL
Primary Outcome Measures
NameTimeMethod
Number of Participants With Abnormal Vital Signsup to 7 years

- Reported as TEAEs - worst CTCAE grade total -

Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)sup to 7 years

Serious adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)

Number of Participants With Abnormal Laboratory Parametersup to 7 years

- Above threshold of 10% and reported as TEAEs - any event (Grade 1-4)

Number of Participants With Treatment-emergent Adverse Events (TEAE)sup to 7 years

Adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)

Secondary Outcome Measures
NameTimeMethod
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