- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373906
Velcade in MALT Lymphoma Patients
November 26, 2013 updated by: Medical University of Vienna
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
16
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
to evaluate the clinical potential of bortezomib
|
to induce objective/histologic responses in patients with MALT-Lymphoma
|
Secondary Outcome Measures
Outcome Measure |
---|
to evaluate the impact of bortezomib on progression free survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markus Raderer, Prof, Department of Internal Medicine I
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
November 27, 2013
Last Update Submitted That Met QC Criteria
November 26, 2013
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Lymphoma, B-Cell
- Lymphoma
- Stomach Neoplasms
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell, Marginal Zone
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- Velcade-MALT-Lymphoma
- Eudract No 2005-003077-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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