Velcade in MALT Lymphoma Patients - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00373906

Purpose

Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.

Condition	Intervention	Phase
MALT Lymphoma	Drug: Bortezomib (Velcade)	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

to evaluate the clinical potential of bortezomib
to induce objective/histologic responses in patients with MALT-Lymphoma

Secondary Outcome Measures:

to evaluate the impact of bortezomib on progression free survival

Estimated Enrollment:

16

Detailed Description:

The objectives of this study are to evaluate the effectivity and the safety of bortezomib 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 of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 years
must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
ECOG status of <_ 2
must be capable of understanding the purpose of the study and given written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373906

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Markus Raderer, Prof

Department of Internal Medicine I

More Information

Study ID Numbers:	Velcade-MALT-Lymphoma, Eudract No 2005-003077-25
Study First Received:	September 7, 2006
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00373906
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

MALT Lymphoma, Bortezomib

Study placed in the following topic categories:

Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
B-cell lymphomas
Bortezomib

Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009