Back to resultsThalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
Primary Purpose
MALT Lymphoma
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Thalidomide, Pharmion
Sponsored by
About this trial
This is an interventional treatment trial for MALT Lymphoma focused on measuring MALT Lymphoma, thalidomide, disseminated MALT Lymphoma or at relapse following HP-eradication, or chemotherapy or radiation
Eligibility Criteria
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
Sites / Locations
- Department of Internal Medicine I
Outcomes
Primary Outcome Measures
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
Secondary Outcome Measures
To evaluate the safety of thalidomide in this patient population and to evaluate
The impact of thalidomide on progression free survival
Full Information
NCT ID
NCT00373646
First Posted
September 7, 2006
Last Updated
June 17, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00373646
Brief Title
Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
Official Title
Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MALT Lymphoma
Keywords
MALT Lymphoma, thalidomide, disseminated MALT Lymphoma or at relapse following HP-eradication, or chemotherapy or radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide, Pharmion
Intervention Description
200 mg p.o. daily
Primary Outcome Measure Information:
Title
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To evaluate the safety of thalidomide in this patient population and to evaluate
Time Frame
6 months
Title
The impact of thalidomide on progression free survival
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Raderer, Prof
Organizational Affiliation
Department of Internal Medicine I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine I
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
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