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


Phase 2
18 Years
N/A
Not Enrolling
Both
MALT Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Markus Raderer, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine I

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

Thalidomide-MALT

NCT ID:

NCT00373646

Start Date:

June 2006

Completion Date:

January 2009

Related Keywords:

  • MALT Lymphoma
  • MALT Lymphoma
  • thalidomide
  • disseminated MALT Lymphoma or at relapse following HP-eradication
  • or chemotherapy or radiation
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

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