Hodgkin's lymphoma MedDRA version: 9.1 Level: LLT Classification code 10020206 Term: Hodgkin's disease
Conditions
Interventions
Product Name: dietyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethil)-naphtalen-2-ylmethyl]-NH4Cl monohydrate
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Con
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy (according to the International Working Group response criteria for HL)of daily oral doses of ITF2357 administered to very high-risk HL patients;Secondary Objective: 1) to evaluate safety and tollerability of multiple oral doses of ITF2357; 2) to evaluate pharmacokinetics of ITF2357 given per os at50mg every six hours; 3) to assess the proportion of patients that, after ITF2357 treatment, can undergo high-dose salvage chemotherapy with either autografting or allografting;Primary end point(s): total number of Objective Response: Complete responses and Partial Responses | — |
Countries
Italy
Outcome results
None listed