Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

Medical University of Vienna8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

MALT Lymphoma

Interventions

Thalidomide, PharmionDRUG

200 mg p.o. daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal Medicine I

Vienna, Austria

Outcomes

Primary Outcomes

To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma

Time frame: 6 months

Secondary Outcomes

To evaluate the safety of thalidomide in this patient population and to evaluate

Time frame: 6 months

The impact of thalidomide on progression free survival

Time frame: 12 months

Data from ClinicalTrials.gov

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