Phase II study of the histone-deacetylase inhibitor ITF2357 in very high-risk relapsed/refractory Hodgkin's lymphoma patients - ND

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

• Registration Number: EUCTR2007-000049-36-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1) Age>=18yrs; 2) history of histologically confirmed Hodgking's Lymphoma 3) subjects are eligible for the trial if they have failed at least 1 cycle of chemotherapy with or without radiotherapy and if they are considered incurable and would be treated with second line or subsequent line salvage regimens mainly with palliative intent; 4)ANC >=1500/uL; PLT >=75000/uL; Hb >=9g/dL; bilirubin <=1.6 mg/dL; AST and ALT <=2.5 x UNL, creatinine <=2.0 mg/dL, K and Mg within normal limits; 5) measurable disease 6) ECOG performance status of 0 or 1
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

1) Acitive bacterial or mycotic infection 2) a marked baseline prolongation of QTc interval > 450 msec 3) the use of concomitant medications that prolong the QTc interval 4) clinically significant cardiovascular disease 5) positive blood test for HIV, HBV and HCV 6) Identification of viral DNA by PCR for EBV, JC Virus, CMV and Herpes Zoster

Study & Design

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