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

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ClinicalTrials.gov Identifier: NCT01884428
Recruitment Status : Unknown
Verified January 2014 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : June 24, 2013
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

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

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: panobinostat Drug: Ifosfamide Drug: Gemcitabine Drug: Vinorelbine Drug: Prednisolone Phase 1

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Panobinostat + IGEV
Panobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)
Drug: panobinostat
Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration
Other Name: LBH-589

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

Drug: Gemcitabine
Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration
Other Name: Gemzar

Drug: Vinorelbine
Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration
Other Name: Navelbine

Drug: Prednisolone
Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration
Other Name: Prelone




Primary Outcome Measures :
  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. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. DLT [ Time Frame: 3 weeks ]
    Incidence of dose limiting toxicities (DLTs)

  2. safety profile [ Time Frame: 3 months ]
    Preliminary safety profile defined as Adverse Events (AEs), Serious Adverse Events ( SAEs) & Changes in Clinical Laboratory Evaluations

  3. Complete Response and Overall Response Rate [ Time Frame: 3 months ]
  4. hematologic toxicity [ Time Frame: 3 months ]
    Assessment of neutropenia and thrombocytopenia incidence, duration, as well as platelet transfusion requirement

  5. CD34+ cells count [ Time Frame: 3 months ]
    Assessment of number of CD34+ collected and number of leukapheresis required to obtain an appropriate collection according to transplant program.

  6. efficacy of PIGEV combination in terms of progression-free survival [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884428


Contacts
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Contact: Armando Santoro, MD +39 (0)2 8224 ext 4080 armando.santoro@humanitas.it
Contact: Rita Mazza, MD +39 (0)2 8224 ext 4780 rita.mazza@humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, MI, Italy, 20089
Contact: Armando Santoro, MD    +39 (0)2 8224 ext 4080    armando.santoro@humanitas.it   
Contact: Rita Mazza, MD    +39 (0)2 8224 ext 4780    rita.mazza@humanitas.it   
Principal Investigator: Armando Santoro, MD         
Sub-Investigator: Rita Mazza, MD         
Sponsors and Collaborators
Armando Santoro, MD
Investigators
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

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Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01884428     History of Changes
Other Study ID Numbers: ONC-2010-003
2010-022452-23 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Armando Santoro, MD, Istituto Clinico Humanitas:
Hodgkin
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Vinorelbine
Ifosfamide
Isophosphamide mustard
Panobinostat
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs