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Completed

NCT Number: NCT00373646

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.

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Key information

Conditions

MALT Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Internal Medicine I

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thalidomide, Pharmion

Drug

200 mg p.o. daily

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. The impact of thalidomide on progression free survival

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 8, 2006
Registry last updated
Jun 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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