Patients with relapsed indolent non-Hodgkin's lymphoma MedDRA version: 18.1 Level: PT Classification code 10029600 Term: Non-Hodgkin's lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main criteria for inclusion: - Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to: o Follicular lymphoma (FL) G1, G2, or G3a o Small lymphocytic lymphoma (SLL) with absolute lymphocyte count = 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: 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
Exclusion criteria
Exclusion criteria: Main criteria for exclusion: - Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3b or 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 or diastolic pressure > 90 mmHg despite optimal medical management).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety run-in part Primary objective is to determine: The recommended phase III dose (RP3D) of copanlisib in combination with standard immunochemotherapy (rituximab and bendamustine [RB] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP]) to be used in the subsequent phase III part of the study Phase III part (randomized, controlled trial) Primary objective is: To evaluate whether copanlisib in combination with standard immunochemotherapy, is superior to standard immunochemotherapy in prolonging progression-free survival (PFS), in patients with relapsed indolent non-Hodgkin?s lymphoma, who have received one or more lines of treatment, including rituximab and alkylating agents, and for whom the combination of rituximab with either bendamustine or CHOP represents a valid therapeutic option;Secondary Objective: Safety run-in part The secondary objectives are to evaluate (for patients that stay on treatment after Cycle 1): Radiological and clinical indicators of treatment efficacy Safety and tolerability of copanlisib in combination with R-B/R-CHOP Phase III part (randomized, controlled trial) Secondary objectives are to evaluate: Other radiological and clinical indicators of treatment efficacy (objective response rate (ORR), duration of response (DOR), complete response rate (CRR), time to progression (TTP), time to next antilymphoma treatment (TTNT), overall survival (OS, 5 year survival rate), time to improvement and the time to deterioration in diseaserelated symptoms - physical) Safety and tolerability of copanlisib in combination with R-B/R-CHOP;Primary end point(s): The primary completion event for this study is PFS (progression assessed by central review or death from any cause if death occurs before progression). The analysis will be performed when approximately 273 PFS events in FL patients occur.;Timepoint(s) of evaluation of this end point: The analysis will be performed when approximately 273 PFS events in FL | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables are objective response rate (ORR), duration of response (DOR), complete response rate (CRR), time to progression (TTP), time to next anti-lymphoma treatment (TTNT), overall survival (OS, 5 year survival rate), time to improvement and the time to deterioration in disease-related symptoms - physical (disease-related symptoms - physical (DRS-P)) of at least 3 points of lymphoma as measured by the FLymSI-18 questionnaire (FLymSI = NCCN-FACT Lymphoma Symptom Index).;Timepoint(s) of evaluation of this end point: The analysis will be performed when approximately 273 PFS events in FL patients occur. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Luxembourg, Mexico, New Zealand, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactBayer Clin. Trials Contact CTP Team
Bayer HealthCare AG
Outcome results
None listed