Back to resultsA Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
Primary Purpose
Hodgkin Disease
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Ifosfamide, Gemcitabine, Vinorelbine
Bortezomib + IGEV
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Disease focused on measuring Hodgkin disease, Salvage therapy, Bortezomib, Transplantation
Eligibility Criteria
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.
Sites / Locations
- Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
B-IGEV (Bortezomib + IGEV)
Outcomes
Primary Outcome Measures
PET negativity rate obtained with IGEV or B-IGEV will be compared
Secondary Outcome Measures
Full Information
NCT ID
NCT00636311
First Posted
March 11, 2008
Last Updated
September 1, 2010
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT00636311
Brief Title
A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease
Keywords
Hodgkin disease, Salvage therapy, Bortezomib, Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
Arm Title
2
Arm Type
Experimental
Arm Description
B-IGEV (Bortezomib + IGEV)
Intervention Type
Drug
Intervention Name(s)
Ifosfamide, Gemcitabine, Vinorelbine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib + IGEV
Intervention Description
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17229633
Citation
Santoro A, Magagnoli M, Spina M, Pinotti G, Siracusano L, Michieli M, Nozza A, Sarina B, Morenghi E, Castagna L, Tirelli U, Balzarotti M. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica. 2007 Jan;92(1):35-41. doi: 10.3324/haematol.10661.
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A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
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