Phase III Copanlisib in Rituximab-refractory iNHL


About this study

Assess the efficacy and safety of copanlisib monotherapy

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


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