Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT01884428 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hodgkin's Lymphoma | Drug: panobinostat Drug: Ifosfamide Drug: Gemcitabine Drug: Vinorelbine Drug: Prednisolone | Phase 1 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Panobinostat + IGEV
Panobinostat + IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine, Prednisolone)
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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 |
- 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 ]
- DLT [ Time Frame: 3 weeks ]Incidence of dose limiting toxicities (DLTs)
- safety profile [ Time Frame: 3 months ]Preliminary safety profile defined as Adverse Events (AEs), Serious Adverse Events ( SAEs) & Changes in Clinical Laboratory Evaluations
- Complete Response and Overall Response Rate [ Time Frame: 3 months ]
- hematologic toxicity [ Time Frame: 3 months ]Assessment of neutropenia and thrombocytopenia incidence, duration, as well as platelet transfusion requirement
- 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.
- 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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
| 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 |
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Hodgkin Lymphoma |
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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 |