MALT LymphomaPhase 2NCT00373906
Velcade in MALT Lymphoma Patients
A Phase 2 study testing Bortezomib (Velcade) in people with MALT Lymphoma, run by Medical University of Vienna.
Trial summary
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MALT Lymphoma
- What is being tested?
- Bortezomib (Velcade)
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
- with first or greater relapse after HP-eradication, radiation or chemotherapy ,
- age > 18 years
- must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
- ECOG status of <_ 2
- must be capable of understanding the purpose of the study and given written informed consent
Who cannot join
None listed.
About this study
Official title: Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
Read the detailed description
The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.
It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.
- Conditions
- MALT Lymphoma
- Being tested
- Bortezomib (Velcade)
- Keywords
- MALT Lymphoma, Bortezomib
- 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 (Velcade)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the clinical potential of bortezomib
to induce objective/histologic responses in patients with MALT-Lymphoma
Secondary outcomes (1)
to evaluate the impact of bortezomib on progression free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
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 MALT LymphomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Markus Raderer, Prof, Principal investigator, Department of Internal Medicine I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373906
- Sponsor's protocol ID
- Velcade-MALT-Lymphoma
- Other IDs
- Eudract No 2005-003077-25
- Status last verified
- May 2008
- First submitted
- 7 Sep 2006
- Last updated
- 27 Nov 2013
- Results posted
- No
Publications
Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.
PubMed 19336742
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
- ClinicalTrials.gov ID
- NCT00373906
- Acronym / sponsor ID
- Velcade-MALT-Lymphoma
- Conditions
- MALT Lymphoma
- Keywords
- MALT Lymphoma, Bortezomib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- First posted
- 8 Sep 2006 (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.
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
Detailed description
The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.
It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.
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 (6 listed)
- patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
- with first or greater relapse after HP-eradication, radiation or chemotherapy ,
- age > 18 years
- must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
- ECOG status of <_ 2
Key exclusion criteria (0 listed)
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 (Velcade) | Drug | – |
Primary outcome
to evaluate the clinical potential of bortezomib
to induce objective/histologic responses in patients with MALT-Lymphoma
1 secondary outcome
to evaluate the impact of bortezomib on progression free survival
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 27 Nov 2013.
- Derived from this study: PubMed 19336742Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.
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Hematologic Cancer
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.
Markus Raderer, Prof principal investigator
Department of Internal Medicine I
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib (Velcade) in people with MALT Lymphoma, run by Medical University of Vienna.
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 6 inclusion and 0 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
to evaluate the clinical potential of bortezomib. The study lists 2 primary outcomes in all. 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 NCT00373906, 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 27 Nov 2013.