Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

NCT ID: NCT00373646

Last Updated: 2009-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MALT Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thalidomide, Pharmion

200 mg p.o. daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dept of Internal Medicine I

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Markus Raderer, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine I

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Internal Medicine I

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eudract number 2005-000008-14

Identifier Type: -

Identifier Source: secondary_id

Thalidomide-MALT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
NCT03478514 ACTIVE_NOT_RECRUITING PHASE2