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Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

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ClinicalTrials.gov Identifier: NCT00373646
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : June 18, 2009
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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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 Design
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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
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Thalidomide

Arms and Interventions
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Intervention Details:
  • Drug: Thalidomide, Pharmion
    200 mg p.o. daily

Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00373646


Locations
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Austria
Department of Internal Medicine I
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I
More Information
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Responsible Party: Medical University of Vienna, Dept of Internal Medicine I
ClinicalTrials.gov 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
thalidomide
disseminated MALT Lymphoma or at relapse following HP-eradication
or chemotherapy or radiation
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Thalidomide
 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