Chronic lynphocytic leukemia (CLL) refractory/relapsed after conventional chemotherapy or relapsed after autologous bone marrow transplantation MedDRA version: 6.1 Level: PT Classification code 10008958
Conditions
Interventions
Product Code: 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: ? Confirmed diagnosis of CLL according to the NCI Working Group criteria. ? Male and female patients of age >=18 and 1 polychemotherapy regimen) or relapsed after autologous bone marrow transplantation ? ECOG performance score of =10.0x109/l and platelets >100.0x109/l after recovery from a previous therapy ? Percentage of CD9+/CD5+ leukemic cells >50% ? Adequate cardiac, pulmonary and renal function, as defined by LVEF >45%, FEV >50% and creatinine =50ml/min ? Serum bilirubine LLN ? Normal values for FT4 and TSH (patients may be on thyroid hormone replacement) ? Negative test for beta-HCG for women in fertile age, or breast feeding women. ? 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. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients with Autoimmune haemolytic anaemia, Autoimmune Thrombocytopenic Purpura and Fischer Evans Syndrome . ? Patients with other autoimmune diseases. ? Prior treatment with an HDAC inhibitor. ? Treatment with Rituximab or Alemtuzumab within 90 days prior to study therapy. ? Patients HIV positive, or patients with active HBV and/or HCV or cirrhosis. ? Patients with active uncontrolled viral or bacterial or mycotic infection. ? 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. ? Patients in treatment with corticosteroids ? 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. ? Uncontrolled hypertension. ? Malabsorption syndromes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate of complete or partial response in all patients;Secondary Objective: 1) Evaluate safety and tolerability 2) Rate of total responders (complete + partial responders) 3) 6 months progression free survival 4) Evaluate ITF2357 effects on ematological parameters;Primary end point(s): Rate of complete or partial response in all patients | — |
Countries
Italy
Outcome results
None listed