Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
6 months
No
Markus Raderer, Prof
Principal Investigator
Department of Internal Medicine I
Austria: Federal Ministry for Health and Women
Thalidomide-MALT
NCT00373646
June 2006
January 2009
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