At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
ITF2357drug
Likely dose
ITF2357 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma Patients
In Brief
A Phase 2 clinical trial evaluating ITF2357 for Hodgkin's Lymphoma. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study has the following objectives: Primary Objective * To evaluate the anti-lymphoma efficacy of daily oral doses of ITF2357 followed by intravenous Mechlorethamine administered to patients with refractory/relapsed Hodgkin's lymphoma. Secondary Objective \- To evaluate the safety and tolerability of multiple courses of ITF2357 followed by Mechlorethamine in a population of chemotherapy pretreated patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin's Lymphoma
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedNov 2008
Primary CompletionJul 2010
Study CompletionSep 2010
TodayJul 2026
First PostedNov 18, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.6 years ago
Interventions
ITF2357drug
ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.