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

NCT01884428 | Unknown Phase 1

• 2 other identifiers: ONC-2010-0032010-022452-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 recommended phase II dose

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (6)

• DLT

  3 weeks

• safety profile

  3 months

• Complete Response and Overall Response Rate

  3 months

• hematologic toxicity

  3 months

• CD34+ cells count

  3 months

Study Arms (1)

Panobinostat + IGEV

EXPERIMENTAL

Panobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)

Drug: panobinostat; Drug: Ifosfamide; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Prednisolone

Interventions

panobinostat DRUG

Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration

Also known as: LBH-589

Panobinostat + IGEV

Ifosfamide DRUG

Ifosfamide 2000 mg/m2 on days 1 to 4 as a 2-hour infusion for a maximum of 4 cycles of three weeks duration

Also known as: Ifex

Panobinostat + IGEV

Gemcitabine DRUG

Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration

Also known as: Gemzar

Panobinostat + IGEV

Vinorelbine DRUG

Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration

Also known as: Navelbine

Panobinostat + IGEV

Prednisolone DRUG

Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration

Also known as: Prelone

Panobinostat + IGEV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armando Santoro, MD: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Panobinostat; Ifosfamide; Gemcitabine; Vinorelbine; Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Santoro, MD

CONTACT

+39 (0)2 8224; armando.santoro@humanitas.it

Rita Mazza, MD

CONTACT

+39 (0)2 8224; rita.mazza@humanitas.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 24, 2013
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

IT (1)