Clinical trial · Interventional
Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases
A Phase IIA Study of the Histone-deacetylase Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: To evaluate efficacy and safety of ITF2357 in the treatment of patients with JAK2V617F positive myeloproliferative diseases \[Polycythemia Vera (PV), Essential Thrombocytosis (ET), Myelofibrosis (MF)\]. Efficacy was evaluated by ad hoc haematological and clinical criteria for PV and ET, and by internationally established response criteria (EUMNET criteria) for MF. Safety was evaluated by number of subjects experiencing an Adverse Event (AE), type, frequency, severity, timing and relatedness of AEs, including changes in vital signs and clinical laboratory results. Secondary Objective: To evaluate the JAK2 mutated allele burden by quantitative Real-Time Polymerase Chain Reaction (qRTPCR).
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 |
|---|---|---|---|
| Myeloproliferative Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITF2357 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ITF2357
- description
- Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
- interventionNames
- Drug: ITF2357
Primary outcomes (1)
- measure
- Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
- timeFrame
- Every single week from week 1 to week 24 of treatment
- description
- Patients with Objective Response were defined as those patients achieving a complete, major, moderate or minor (only for Myelofibrosis patients) response during the experimental treatment course. The "best response" is reported hereunder by intensity of response.
Secondary outcomes (2)
- measure
- Change in JAK2 Mutated Allele Burden
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed Consent Form * Male or female, age ≥ 18 years * Confirmed diagnosis of PV/ET/MF according to the revised World Health Organisation criteria * JAK-2 V617F positivity * In need of cytoreductive therapy when hydroxyurea is not indicated (e.g. young patients) or when refractoriness to the drug is documented Exclusion Criteria: * Active bacterial or fungal infection requiring antimicrobial treatment on Day 1 * Patients of childbearing potential without a negative pregnancy test prior to initiation of the study drug * Pregnancy or lactation * A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \> 450 ms, according to Bazett's correction formula - see appendix G for the formula) * The use of concomitant medications that prolong the QT/QTc interval (see appendix F for full list) * Concomitant acute coronary syndromes; uncontrolled hypertension * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of any cardiac arrhythmia requiring medication (irrespective of its severity) * A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Active Epstein Barr Virus (EBV) infection (i.e. positive serology IgM) * Known HIV infection * Active hepatitis B and/or C infection * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications * Eastern Cooperative Oncology Group (ECOG) performance status 3 or greater * Platelets count \<100x109/L within 14 days before enrolment * Absolute neutrophil count \<1.2x109/L within 14 days before enrolment * Percentage of blast cells in peripheral blood \>10% within 14 days before enrolment * Serum creatinine \>2xULN (Upper limit of normal) * Total serum bilirubin \>1.5xULN * Serum AST (aspartate aminotransferase) / ALT (alanine aminotransferase) \> 3xULN * Interferon alpha within 14 days before enrolment * Hydroxyurea within 14 days before enrolment * Anagrelide within 7 days before enrolment * Any other investigational drug within 28 days before enrolment
References
Publications (0)
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