Last updated on November 2015

Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma | Non-Hodgkin's
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype
    limited to:
    Follicular lymphoma G1-2-3a
    Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study
    Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
    Marginal zone lymphoma (splenic, nodal, or extranodal)
    Patients must have relapsed after at least 1 but at most 3 prior lines of therapy,
    including rituximab and alkylating agents. A previous regimen is defined as one of the
    following: at least 2 months of single-agent therapy; at least 2 consecutive cyclesof
    polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to
    other PI3Ki is acceptable provided there is no resistance.
    Non-WM must have at least one bi-dimensionally measurable lesion (that has not been
    previously irradiated) according to 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.
    Male or female patients ≥ 18 years of age
    Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    Life expectancy of at least 3 months
    Availability of fresh tumor tissue and/or archival tumor tissue at Screening
    Adequate baseline laboratory values collected within 7 days of starting the study
    Left ventricular ejection fraction (LVEF) ≥ 50%

You may not be eligible for this study if the following are true:

  • Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed
    disease, or chronic lymphocytic leukemia.
    Rituximab resistance at any line of therapy (resistance defined as lack of response,
    or progression within 6 months of the last course of treatment with a rituximab
    containing regimen
    History or concurrent condition of interstitial lung disease and/or severely impaired
    lung function (as judged by the investigator)
    Known lymphomatous involvement of the central nervous system
    HbA1c > 8.5% at Screening
    Known history of human immunodeficiency virus (HIV) infection
    Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for Hepatitis B
    urface antigen (HBsAg or HBcAb) will be eligible if they are negative for HBV-DNA,
    these patients should receive prophylactic antiviral therapy. Patients positive for
    anti-HCV antibody will be eligible if they are negative for HCV-RNA.
    Uncontrolled hypertension despite optimal medical management (per investigator´s
    Congestive heart failure > New York Heart Association (NYHA) class 2

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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