Primary or secondary DLBCL refractory/relapsed after conventional chemotherapy MedDRA version: 9.1 Level: LLT Classification code 10003899 Term: B-cell lymphoma
Conditions
Interventions
Product Name: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed diagnosis of DLBCL according the WHO classification Age 60 years Patients relapsed/refractory to conventional chemotherapy 1 polychemotherapy regimen with or without prior immunotherapy Measurable disease Stage II-IV. ECOG performance score of 0-2 Adequate hepatic and renal function, as defined by serum transaminases 2.5x ULN, bilirubin 1.5x ULN and creatinine 1.5x ULN. Documentation of written informed consent to participate in the trial. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. At least 4 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities. Negative blood tests for HIV, HBV, HCV Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with any anticancer agent within 4 weeks prior to study therapy. Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, Active uncontrolled bacterial infection. Significant cardiovascular disease i.e., uncontrolled arrhythmias, unstable angina , or a major thromboembolic event myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis in the last 6 months. Malabsorption syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-lymphoma activity of ITF2357.;Secondary Objective: To assess the safety and tolerability of ITF2357. To assess the progression free survival . To assess the overall survival.;Primary end point(s): Number of subjects experiencing an objective response any reduction or disappearance of any symptom related with DLBCL | — |
Countries
Italy
Outcome results
None listed