Clinical trial · Interventional
Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
Open Label, Uncontrolled, Pilot, Phase II Study of ITF2357 Administered Orally to Subjects With Chronic Lymphocytic Leukemia (CLL) Refractory/Relapsed After Conventional Chemotherapy or Relapsed After Autologous Bone Marrow Transplantation
NCT00792831CI-TRIAL-00056183terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol needs complete restructuring in order to make it feasible and to complete the enrollment of 23 patients.
Summary
Brief summary (as posted)
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 rate of responders (complete + partial responders); * to determine the 6 months progression free survival; * to determine the effects of the drug on haematological parameters.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITF2357 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ITF2357
- description
- ITF2357 was supplied as hard gelatine capsules for oral administration at the strength of 100 or 50 mg. Patients had to receive ITF2357 100 mg x 2/die at 12-hour intervals, in fed conditions, for three consecutive months.
- interventionNames
- Drug: ITF2357
Primary outcomes (1)
- measure
- Rate of complete response (CR) or partial response (PR) to ITF2357 in all patients
- timeFrame
- 13 weeks
- description
- ITF2357 was given at 100 mg x 2/die for up to three months. A positive response was defined to be a patient experiencing a complete or partial remission. Complete remission (CR) Absence of lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms. Normal blood count: neutrophils ≥1.5x109/L, platelets \>100x109/L, lymphocytes ≤4.0x109/L, Hb \>11.0 g/dL (not supported by transfusion), BM biopsy: normal cellularity, lymphocytosis \<30%. Partial remission (PR) ≥50% reduction in blood lymphocytes and ≥50% reduction in lymphadenophaty and/or 50% reduction in hepatomegaly and/or splenomegaly. Neutrophils ≥1.5x109/L or 50% improvement over baseline, platelets \>100x109/L or 50% improvement over baseline, Hb \>11.0 g/dL or 50% improvement over baseline (not supported by transfusion) It was considered PR * CR with nodular infiltrates at bone marrow biopsy (RPn) * CR with persistent anemia and thrombocytopenia therapy-related
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.