Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)|
- To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate the safety of thalidomide in this patient population and to evaluate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The impact of thalidomide on progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Drug: Thalidomide, Pharmion
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.