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A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636311
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : September 2, 2010
Information provided by:
Istituto Clinico Humanitas

Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin Disease Drug: Ifosfamide, Gemcitabine, Vinorelbine Drug: Bortezomib + IGEV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: 1
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
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.

Experimental: 2
B-IGEV (Bortezomib + IGEV)
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.

Primary Outcome Measures :
  1. PET negativity rate obtained with IGEV or B-IGEV will be compared [ Time Frame: PET negativity after 4 courses of induction (IGEV or B-IGEV) ]

Information from the National Library of Medicine

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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 Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
  • Age >18 and <65 years
  • Signed informed consent
  • If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
  • If male, patient agrees to use an acceptable barrier method for contraception
  • ECOG performance status <2
  • Platelet count >100.000/mmc
  • Hemoglobin >7.5 g/dL
  • Absolute neutrophil count (ANC) >1.500/mmc
  • Serum calcium <3.5 mmol/L (<14 mg/dL)
  • AST/ALT: <2.5 x the ULN
  • Total bilirubin: <1.5 x the ULN

Exclusion Criteria:

  • Previous treatment with velcade
  • Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
  • Immunotherapy or antibody therapy within 4 weeks before enrollment
  • Experimental drug or medical device within 4 weeks before start of treatment
  • Major surgery within 4 weeks before enrollment
  • History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
  • Peripheral neuropathy of NCI CTCAE Grade 2 or higher
  • Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
  • Need for therapy with concomitant CYP 3A4 inhibitors or inducers
  • HIV-positive, if known
  • Hepatitis B surface antigen-positive or active hepatitis C infection, if known
  • Active systemic infection requiring treatment
  • If female, pregnancy or breast-feeding.

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 identifier (NCT number): NCT00636311

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Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

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Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT00636311     History of Changes
Other Study ID Numbers: ONC-2006-005
EUDRACT 2007-004883-29
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010
Keywords provided by Istituto Clinico Humanitas:
Hodgkin disease
Salvage therapy
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Isophosphamide mustard
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents