Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00373646

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2006

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma [6 months]

Secondary Outcome Measures

To evaluate the safety of thalidomide in this patient population and to evaluate [6 months]
The impact of thalidomide on progression free survival [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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