MALT Lymphoma Clinical Trial
Official title:
Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Verified date | June 2009 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Ministry for Health and Women |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Department of Internal Medicine I | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma | 6 months | No | |
Secondary | To evaluate the safety of thalidomide in this patient population and to evaluate | 6 months | No | |
Secondary | The impact of thalidomide on progression free survival | 12 months | No |
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