NCT00373906

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

November 27, 2013

Status Verified

May 1, 2008

First QC Date

September 7, 2006

Last Update Submit

November 26, 2013

Conditions

MALT Lymphoma

Keywords

MALT Lymphoma, Bortezomib

Outcome Measures

Primary Outcomes (2)

  • to evaluate the clinical potential of bortezomib

  • to induce objective/histologic responses in patients with MALT-Lymphoma

Secondary Outcomes (1)

  • to evaluate the impact of bortezomib on progression free survival

Interventions

Bortezomib (Velcade)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.

    PMID: 19336742DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Markus Raderer, Prof

    Department of Internal Medicine I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Last Updated

November 27, 2013

Record last verified: 2008-05