Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

June 17, 2009 updated by: Medical University of Vienna

Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

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 Overview

Status

Completed

Conditions

MALT Lymphoma

Intervention / Treatment

Drug: Thalidomide, Pharmion

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Vienna, Austria, 1090
    - Department of Internal Medicine I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety of thalidomide in this patient population and to evaluate Time Frame: 6 months	6 months
The impact of thalidomide on progression free survival Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

Principal Investigator: Markus Raderer, Prof, Department of Internal Medicine I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)