Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: MALT Lymphoma

Treatments: Drug: Thalidomide, Pharmion

Study type: Interventional

Funder types: Other

Identifiers

NCT00373646

Thalidomide-MALT

Eudract number 2005-000008-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)