Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373646
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : June 18, 2009
Information provided by:
Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
MALT Lymphoma Drug: Thalidomide, Pharmion Phase 2

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  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Thalidomide
U.S. FDA Resources

Intervention Details:
    Drug: Thalidomide, Pharmion
    200 mg p.o. daily

Primary Outcome Measures :
  1. To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373646

Department of Internal Medicine I
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I

Responsible Party: Medical University of Vienna, Dept of Internal Medicine I Identifier: NCT00373646     History of Changes
Other Study ID Numbers: Thalidomide-MALT
Eudract number 2005-000008-14
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009

Keywords provided by Medical University of Vienna:
MALT Lymphoma
disseminated MALT Lymphoma or at relapse following HP-eradication
or chemotherapy or radiation

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents