Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
NCT00792831 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2022-01-27
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 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
Interventions
- DRUG
-
ITF2357
Histone-Deacetylase Inhibitor
Sponsors & Collaborators
-
Italfarmaco
lead INDUSTRY
Principal Investigators
-
Massimo Martelli, MD · Department of Internal Medicine and Public Health, University of Perugia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-04-30
- Completion
- 2009-04-30
Countries
- Italy
Study Locations
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