Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05003141 - PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies Phase 1
Completed NCT01015248 - Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma Phase 2
Completed NCT00201422 - Eradication of Helicobacter Pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of MALToma N/A
Unknown status NCT00923663 - Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type Phase 2
Completed NCT00783367 - Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas Phase 2
Active, not recruiting NCT01808599 - Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma Phase 2
Completed NCT00117156 - Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma Phase 2
Recruiting NCT05544019 - Study of SGR-1505 in Mature B-Cell Neoplasms Phase 1
Completed NCT00373906 - Velcade in MALT Lymphoma Patients Phase 2