Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 109/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)
Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have previously received rituximab and alkylating agent(s).
Japanese patients ≥ 20 years of age
ECOG performance status ≤ 2 (Eastern Cooperative Oncology Group:ECOG)
Life expectancy of at least 3 months
Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution
Availability of fresh or archival tumor tissue
You may not be if
Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg, defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management)
Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 (NCI-CTC version 4.0) within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events, NCI: National Cancer Institute).
History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia.
Prior treatment with PI3K inhibitors
Systemic corticosteroid therapy (ongoing)
Type I or II diabetes mellitus with HbA1c \> 8.5% or fasting plasma glucose \> 160 mg/dL at Screening
Known history of human immunodeficiency virus (HIV) infection.
Hepatitis B or C requiring treatment
Cytomegalovirus (CMV) PCR positive at baseline
Known lymphomatous involvement of the central nervous system
Clareo Health | Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL
