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

ITALFARMACO0 个研究点开始时间: 2007年6月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•? 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.

发起方

ITALFARMACO