Status:
TERMINATED
Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
Lead Sponsor:
Italfarmaco
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary objective: \- To determine overall response-rate, complete response (CR) or partial response (PR) Secondary objectives: * To assess the safety and tolerability of ITF2357; * to assess total...
Detailed Description
This is an open label, un-controlled, phase II, pilot clinical trial testing ITF2357 in a population of CLL patients relapsed after or refractory to conventional chemotherapy or relapsed after autolog...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CLL according to the NCI Working Group criteria.
- Male and female patients of age \>18 and ≤75 years
- Patients relapsed/refractory within 1 month after conventional chemotherapy (\>1 polychemotherapy regimen) or relapsed within 3 months after autologous bone marrow transplantation
- ECOG performance score of ≤2
- Lymphocytes ≥10.0x10\^9/L and platelets \>75.0x10\^9/L after recovery from a previous therapy
- Percentage of CD19+/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 bilirubin \<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
- 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.
Exclusion
- Patients with Autoimmune haemolytic anaemia, Autoimmune Thrombocytopenic Purpura and Fischer Evans Syndrome.
- Patients with other autoimmune diseases.
- Patients with a marked baseline prolongation of QTc interval (e.g. repeated demonstration of a QTc interval \>450 ms).
- Patients with history of additional risk factors for torsade de pointes (e.g. hearth failure, family history of Long QT Syndrome)
- The use of concomitant medications with potential risk of torsade de pointes and/or that can prolong QTc interval
- Prior treatment with an HDAC inhibitor.
- Treatment with Rituximab or Alemtuzumab within 90 days prior to study therapy.
- Patients HIV positive, patients with active EBV, HBV, HCV infection or liver 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 within 1 month before study start
- 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.
- Breast feeding women
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00792831
Start Date
February 1 2008
End Date
April 1 2009
Last Update
January 27 2022
Active Locations (1)
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1
Department of Internal Medicine and Public Health, University of Perugia
Perugia, Italy, 06074