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Sponsored by: |
Istituto Clinico Humanitas |
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Information provided by: | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00636311 |
The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.
Condition | Intervention | Phase |
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Hodgkin Disease |
Drug: Ifosfamide, Gemcitabine, Vinorelbine Drug: Bortezomib + IGEV |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi |
Estimated Enrollment: | 80 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
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Drug: Ifosfamide, Gemcitabine, Vinorelbine
Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
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2: Experimental
B-IGEV (Bortezomib + IGEV)
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Drug: Bortezomib + IGEV
Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Armando Santoro, MD | +39 02 8224 ext 4080 | armando.santoro@humanitas.it |
Contact: Monica Balzarotti, MD | +39 02 8224 ext 4536 | monica.balzarotti@humanitas.it |
Italy, Milan | |
Istituto Clinico Humanitas | Recruiting |
Rozzano, Milan, Italy, 20089 | |
Contact: Armando Santoro, MD +39 02 8224 ext 4080 armando.santoro@humanitas.it | |
Contact: Monica Balzarotti, MD +39 02 8224 ext 4536 monica@balzarotti@humanitas.it | |
Sub-Investigator: Monica Balzarotti, MD |
Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
Responsible Party: | Istituto Clinico Humanitas ( Armando Santoro, MD ) |
Study ID Numbers: | ONC-2006-005, EUDRACT 2007-004883-29 |
Study First Received: | March 11, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00636311 History of Changes |
Health Authority: | Italy: Ministry of Health |
Hodgkin disease Salvage therapy Bortezomib Transplantation |
Antimetabolites Prednisone Immunoproliferative Disorders Immunologic Factors Hodgkin Lymphoma, Adult Bortezomib Hodgkin's Disease Immunosuppressive Agents Antiviral Agents Protease Inhibitors Lymphatic Diseases Ifosfamide |
Vinorelbine Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Gemcitabine Antineoplastic Agents, Phytogenic Alkylating Agents Mesna Lymphoma Hodgkin Disease Isophosphamide mustard |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Therapeutic Uses Gemcitabine Lymphoma Hodgkin Disease Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Bortezomib Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Ifosfamide Neoplasms Vinorelbine Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic |