Lymphoma, Mucosa-Associated Lymphoid TissuePhase 2NCT00210327
VELCADE in MALT Lymphoma Pretreated With Prior Systemic Therapy
A Phase 2 study testing Bortezomib (drug) in people with Lymphoma, Mucosa-Associated Lymphoid Tissue, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Switzerland.
Trial summary
The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mucosa-Associated Lymphoid Tissue
- What is being tested?
- Bortezomib (drug)
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2005to Apr 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven d MALT lymphoma at any extranodal site
- any stage (Ann Arbor I-IV)
- relapsed or refractory disease pretreated with prior chemotherapy regimens +/- anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of therapy)
- no evidence of histologic transformation to a high grade lymphoma
- measurable or evaluable disease
- age > 18 years
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- full recovery from previous therapy, with life expectancy of at least 6 months
- ECOG performance status 0-2
- for primary gastric localized H. pylori-positive disease at diagnosis:
- persistent disease 1 year after documented H. pylori infection eradication
- clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication
- no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
- no corticosteroids during the last 4 weeks, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- adequate renal function (calculated or measured creatinine clearance >30 mL/minute), liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal) and bone marrow function
- no evidence of active opportunistic infections
- no known HIV infection
- no active HBV and/or HCV infection
- no serious medical illness likely to interfere with participation in this clinical study
- voluntary written informed consent before performance of any study-related procedure
- female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study
Who cannot join
- prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1(CIN1) or localized non-melanomatous skin cancer
- other investigational drugs within 14 days before enrollment
- evidence of symptomatic central nervous system (CNS) disease
- severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement
- evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment
- known hypersensitivity to bortezomib, boron or mannitol
- pregnant or lactating status, confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, 6500
About this study
Official title: Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-cell Lymphoma of MALT-type Pretreated With Prior Systemic Therapy Regimen (X05142)
The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen
- Being tested
- Bortezomib (drug)
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses
Secondary outcomes (3)
Safety, as acute and long-term toxicity
Response duration (RD) (time to relapse or progression) in responders
Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Mucosa-Associated Lymphoid TissueStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Investigators
- Franco Cavalli, MD, Study chair, International Extranodal Lymphoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210327
- Sponsor's protocol ID
- IELSG25A
- Status last verified
- Jul 2009
- First submitted
- 13 Sep 2005
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-cell Lymphoma of MALT-type Pretreated With Prior Systemic Therapy Regimen (X05142)
- ClinicalTrials.gov ID
- NCT00210327
- Acronym / sponsor ID
- IELSG25A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Jul 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Sep 2005 (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 primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- histologically proven d MALT lymphoma at any extranodal site
- any stage (Ann Arbor I-IV)
- relapsed or refractory disease pretreated with prior chemotherapy regimens +/- anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of therapy)
- no evidence of histologic transformation to a high grade lymphoma
- measurable or evaluable disease
Key exclusion criteria (8 listed)
- prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1(CIN1) or localized non-melanomatous skin cancer
- other investigational drugs within 14 days before enrollment
- evidence of symptomatic central nervous system (CNS) disease
- severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement
- evidence of ≥ grade 2 peripheral neuropathy within 14 days 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 |
|---|---|---|
| Bortezomib (drug) | Drug | – |
Primary outcome
Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses
3 secondary outcomes
Safety, as acute and long-term toxicity
Response duration (RD) (time to relapse or progression) in responders
Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients
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 22 Jul 2009.
- Click here for more information about this studyLink provided by the sponsor.
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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.
Franco Cavalli, MD study chair
International Extranodal Lymphoma Study Group
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 Bortezomib (drug) in people with Lymphoma, Mucosa-Associated Lymphoid Tissue, run by International Extranodal Lymphoma Study Group (IELSG) at 1 site in Switzerland.
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 20 inclusion and 8 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 22 Jul 2009. 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 Switzerland. 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?
Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2009.