Velcade in MALT Lymphoma Patients

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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MALT Lymphoma

Keywords

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MALT Lymphoma, Bortezomib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bortezomib (Velcade)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Markus Raderer, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine I

Countries

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Austria

References

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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.

Reference Type DERIVED

PMID: 19336742 (View on PubMed)

Other Identifiers

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Eudract No 2005-003077-25

Identifier Type: -

Identifier Source: secondary_id

Velcade-MALT-Lymphoma