Status:
UNKNOWN
Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
Lead Sponsor:
Armando Santoro, MD
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 rec...
Detailed Description
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. Elig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01884428
Start Date
July 1 2011
End Date
December 1 2015
Last Update
January 29 2014
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, MI, Italy, 20089