Open label, uncontrolled, pilot, phase II study of histone-deacetylase inhibitor ITF2357 administered orally to subjects with chronic lynphocytic leukemia (CLL) refractory/relapsed after conventional chemotherapy or relapsed after autologous bone marrow transplantation - ND
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10008958Chronic lynphocytic leukemia (CLL) refractory/relapsed after conventional chemotherapy or relapsed after autologous bone marrow transplantation
- Registration Number
- EUCTR2006-005465-19-IT
- Lead Sponsor
- ITALFARMACO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
? Confirmed diagnosis of CLL according to the NCI Working Group criteria.
? Male and female patients of age >=18 and <=75 years
? Patients relapsed/refractory to conventional chemotherapy (>1 polychemotherapy regimen) or relapsed after autologous bone marrow transplantation
? ECOG performance score of <=2
? Limphocytes >=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 <=1.5 ULN or creatinine clearance >=50ml/min
? Serum bilirubine <1.5xULN, AST and ALT <2.5xULN
? Serum potassium, phosphorus, total calcium, magnesium >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
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Rate of complete or partial response in all patients;Secondary Objective: 1) Evaluate safety and tolerability <br><br>2) Rate of total responders (complete + partial responders)<br><br>3) 6 months progression free survival<br><br>4) Evaluate ITF2357 effects on ematological parameters;Primary end point(s): Rate of complete or partial response in all patients
- Secondary Outcome Measures
Name Time Method