A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma.
- Conditions
- patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL)MedDRA version: 20.0Level: PTClassification code 10029600Term: Non-Hodgkin's lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001088-38-IT
- Lead Sponsor
- BAYER HEALTHCARE AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 700
Main criteria for inclusion:- Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:o Follicular lymphoma (FL) G1, G2, or G3ao Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5x109/L at the time of diagnosis and at study entryo Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM)o Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)- Patients must have relapsed after at least 1 prior line 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 cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K inhibitors is acceptable provided there is no resistance (treatment stopped for other reasons than progressive disease).- Non-WM patients 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.- 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 as assessed within 7 days before starting study treatment.- Left ventricular ejection fraction = 50%.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Main criteria for exclusion:- Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3bor transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.- 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).- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening.- 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.- Human immunodeficiency virus (HIV) infection.- Hepatitis B (HBV) and C (HCV) infection. Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative and Anti-HBs positive) will be eligible.- Congestive heart failure > New York Heart Association (NYHA) class 2.- Uncontrolled hypertension (systolic blood pressure > 150 mmHg ordiastolic pressure > 90 mmHg despite optimal medical management).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method