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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

Phase 1
18 Years
65 Years
Open (Enrolling)
Hodgkin's Lymphoma

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Trial Information

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.

Inclusion Criteria:

- Diagnosis of relapsed or refractory classical HL

- Measurable disease

- One or two prior systemic lines of treatment

- PS(ECOG) 0-2

- Absence of bone marrow infiltration

- Adequate laboratory values for bone marrow, liver and renal functionality

Exclusion Criteria:

- prior or concurrent treatment with a DAC inhibitor including panobinostat

- valproic acid therapy for any medical condition during the study or within 5 days
prior to the first panobinostat treatment

- previous autologous hematopoietic stem cell transplant

- other concurrent therapy intended to treat the primary cancer including chemotherapy,
investigational or biologic agents or other antitumor agents

- impaired cardiac function or unstable AF

- known history of HIV seropositivity, chronic hepatitis, or other active viral

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small
bowel resection)

- pregnant or breast feeding women

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas


Italy: Ministry of Health

Study ID:




Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma