Open label, uncontrolled, pilot, phase II study of histone-deacetylase inhibitor ITF2357 administered orally to subjects aged over 60 years with primary or secondary DLBCL refractory/ relapsed after conventional chemotherapy with or without prior immunotherapy - ND
- Conditions
- Primary or secondary DLBCL refractory/relapsed after conventional chemotherapyMedDRA version: 9.1Level: LLTClassification code 10003899Term: B-cell lymphoma
- Registration Number
- EUCTR2006-002113-12-IT
- Lead Sponsor
- ITALFARMACO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
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