Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin?s Lymphoma Patients - ND

• Conditions: Hodgkin's lymphoma; MedDRA version: 9.1Level: LLTClassification code 10020206Term: Hodgkin's disease

• Registration Number: EUCTR2007-007091-41-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Written Informed Consent.
Age ≥18 years.
Histologically confirmed diagnosis of Hodgkin?s lymphoma.
Subjects who have failed second-line or subsequent-line salvage chemo-radiotherapy regimens for whom no other treatment options of proven efficacy can be given.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
-ANC ≥1500/µL; Platelet count ≥75000/µL
-Hemoglobin ≥9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)
-Total bilirubin ≤1.6 mg/dL; AST or ALT ≤2.5 times the upper limit of normal
-Serum creatinine ≤2.0 mg/dL or creatinine clearance >50 mL/min
-Serum Potassium and Magnesium within normal limits
Subjects with at least one bi-dimensional lesion measurable by CT-scan or MRI, according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group (J Clin Oncol, 25:579-586, 2007).
ECOG performance status of 0 or 1
Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
Life expectancy of >3 months
Subjects receiving intravenous Mechlorethamine (6 mg/sqm) as single agent at least 4 weeks before study entry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active bacterial or mycotic infection requiring antimicrobial treatment
Pregnancy or lactation
Anticancer chemotherapy or radiotherapy during the study or within 4 weeks of study entry.
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 I for the formula)
Use of concomitant medications that prolong the QT/QTc interval (see appendix H for full list)
Clinically significant cardiovascular disease including:
-Uncontrolled hypertension, myocardial infarction, unstable angina
-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 TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Positive blood test for HIV, HBV and HCV
Identification of viral DNA by quantitative PCR for EBV and JC virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the anti-lymphoma efficacy of daily oral doses of ITF2357 folllowed 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 folllowed by Mechlorethamine in a population of chemotherapy pretreated patients;Primary end point(s): Assessment of the objective response rate, including complete response and partial response, according to the Revised Response Criteria for Malignant Lymphoma of the International Working Group