- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373646
Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
June 17, 2009 updated by: Medical University of Vienna
Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or radiation.
Study Overview
Detailed Description
The objectives of this study are to evaluate the effectivity and the safety of thalidomide 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 size of 16 patients.
Thalidomide is given orally at an initial dose of 100 mg for a maximum duration of 6 months.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Vienna, Austria, 1090
- Department of Internal Medicine I
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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
- Must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
- ECOG status _< 2
- Must be capable of understanding the purpose of the study and have 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 |
Time Frame |
---|---|
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety of thalidomide in this patient population and to evaluate
Time Frame: 6 months
|
6 months
|
The impact of thalidomide on progression free survival
Time Frame: 12 months
|
12 months
|
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
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 Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
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)
June 18, 2009
Last Update Submitted That Met QC Criteria
June 17, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, B-Cell, Marginal Zone
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- Thalidomide-MALT
- Eudract number 2005-000008-14
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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