Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
Patients will received 4 p-IGEV courses repeated every 3 weeks in the absence of
unacceptable toxicity, whenever an objective response is observed at disease evaluation
performed after II cycle.
Eligible patients will be accrued in cohorts of 3 patients at each dose level and dose
escalation will be performed following the standard 3+3 rule.
Three patients will be treated for each dose-level, starting from level 1, for one cycle: if
no dose-limiting toxicities (DLTs) will be recorded after the first cycle, treatment will be
continued in those patients until study completion or unacceptable toxicity and three new
patients will be treated at the next dose level. However, if one out of 3 patients will
develop a DLT, the same dose-level will be administered to three additional patients for one
cycle. If no one of those additional patients will experience a DLT, dose escalation will
continue. If more than one over 3 or 6 patients will develop a DLT after the first cycle in
any cohort, MTD will be reached. Six further patients will be treated at the lower dose in
order to obtain more information about the optimal dose for phase II trials and to
characterize pharmacokinetic profiles of this combination. If DLT will be found at level 1
(20 mg), 3 patients will be treated at dose -1 (10 mg). If no more than 1 patient experience
toxicity, other 3 patients will be treated to assess more information about pharmacokinetic
profiles and safety.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) or the recommended phase II dose defined as the highest dosage cohort at which no more than one of six patients will experience a DLT in the first treatment cycle.
Armando Santoro, MD
Istituto Clinico Humanitas
Italy: Ministry of Health