Hodgkin DiseasePhase 2NCT00636311
A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
A Phase 2 study testing Ifosfamide, Gemcitabine, Vinorelbine and Bortezomib + IGEV in people with Hodgkin Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Ifosfamide, Gemcitabine, Vinorelbine and Bortezomib + IGEV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Hodgkin Disease
- Being tested
- Ifosfamide, Gemcitabine, Vinorelbine, Bortezomib + IGEV
- Keywords
- Hodgkin disease, Salvage therapy, Bortezomib, Transplantation
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifosfamide, Gemcitabine, VinorelbineDrug
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.
Bortezomib + IGEVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine) Receives: Drug: Ifosfamide, Gemcitabine, Vinorelbine |
| 2 | Experimental | B-IGEV (Bortezomib + IGEV) Receives: Drug: Bortezomib + IGEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET negativity rate obtained with IGEV or B-IGEV will be compared
Measured: PET negativity after 4 courses of induction (IGEV or B-IGEV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636311
- Sponsor's protocol ID
- ONC-2006-005
- Other IDs
- EUDRACT 2007-004883-29
- Status last verified
- Sep 2010
- First submitted
- 11 Mar 2008
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17229633
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00636311
- Acronym / sponsor ID
- ONC-2006-005
- Conditions
- Hodgkin Disease
- Keywords
- Hodgkin disease, Salvage therapy, Bortezomib, Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ifosfamide, Gemcitabine, VinorelbineIGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine) |
| 2 | Experimental | Drug: Bortezomib + IGEVB-IGEV (Bortezomib + IGEV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifosfamide, Gemcitabine, VinorelbineIfosfamide 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. | Drug | 1 |
| Bortezomib + IGEVBortezomib 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. | Drug | 2 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
- Background: PubMed 17229633Santoro 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifosfamide, Gemcitabine, Vinorelbine and Bortezomib + IGEV in people with Hodgkin Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2010.