Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armando Santoro, MD
• Treatments: Gemcitabine; Ifosfamide; Isophosphamide mustard; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Panobinostat; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vinorelbine

Criteria

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 infections

• 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