Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00373646
First received: September 7, 2006
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
MALT Lymphoma
Drug: Thalidomide, Pharmion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of thalidomide in this patient population and to evaluate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The impact of thalidomide on progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide, Pharmion
    200 mg p.o. daily
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373646

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

No publications provided

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
Study First Received: September 7, 2006
Last Updated: June 17, 2009
Health Authority: Austria: Federal Ministry for Health and Women

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:
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
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014