Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

MALT Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373646
• Other study ID #: Thalidomide-MALT
• Secondary ID: Eudract number 2
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: June 17, 2009
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• MALT Lymphoma

Intervention

Drug:
• Thalidomide, Pharmion
200 mg p.o. daily

Locations

Country	Name	City	State
Austria	Department of Internal Medicine I	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma		6 months	No
Secondary	To evaluate the safety of thalidomide in this patient population and to evaluate		6 months	No
Secondary	The impact of thalidomide on progression free survival		12 months	No