NCT00210327

CompletedPhase 2

VELCADE in MALT Lymphoma Pretreated With Prior Systemic Ther...

International Extranodal Lymphoma Study Group (IELSG)Source

International Extranodal Lymphoma Study Group (IELSG)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

IELSG25A

Study Type

interventional

Estimated enrollment

33

Locations

1 country

Sites

1

Timeline

Study Start

July 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Actual (reported)

Study Completion

April 2009

Actual (reported)

Brief Summary

The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 33 participants
Study completion date: April 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Primary Completion
November 2008
Actual (reported)
Study Completion
April 2009
Actual (reported)

Last Updated: July 22, 2009
Status Verified: July 2009
Last Update Submitted: July 21, 2009

Conditions

Lymphoma, Mucosa-Associated Lymphoid Tissue

Outcome Measures

Primary Outcomes (1)

Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses

Secondary Outcomes (3)

Safety, as acute and long-term toxicity
Response duration (RD) (time to relapse or progression) in responders
Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients

Interventions

Bortezomib (drug)Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

histologically proven d MALT lymphoma at any extranodal site
any stage (Ann Arbor I-IV)

Sponsors & Collaborators

International Extranodal Lymphoma Study Group (IELSG)
Otherlead

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

BortezomibPharmaceutical Preparations

Condition Hierarchy (Ancestors)

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

Study Officials

Franco Cavalli, MD
International Extranodal Lymphoma Study Group
STUDY CHAIR

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 13, 2005

First Posted

September 21, 2005

Study Start

July 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Actual (reported)

NCT00656812

Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma

Phase 2Completed

NCT00923663

Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Phase 2Unknown

NCT01015248

Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

Phase 2Completed

NCT07554898

Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma

Phase 2Recruiting

NCT02853370

Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma

Phase 2Completed

NCT06583837

Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

Phase 2Active Not Recruiting

relapsed or refractory disease pretreated with prior chemotherapy regimens +/- anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of therapy)

no evidence of histologic transformation to a high grade lymphoma

measurable or evaluable disease

age \> 18 years

full recovery from previous therapy, with life expectancy of at least 6 months

ECOG performance status 0-2

for primary gastric localized H. pylori-positive disease at diagnosis:

persistent disease 1 year after documented H. pylori infection eradication

clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication

no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks

no corticosteroids during the last 4 weeks, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms

adequate renal function (calculated or measured creatinine clearance \>30 mL/minute), liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal) and bone marrow function

no evidence of active opportunistic infections

+5 more criteria

You may not qualify if:

prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1(CIN1) or localized non-melanomatous skin cancer
other investigational drugs within 14 days before enrollment
evidence of symptomatic central nervous system (CNS) disease
severe impairment of bone marrow function (ANC \<1.0x109/L, PLT \<30x109/L within 14 days before enrollment), unless due to lymphoma involvement
evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment
known hypersensitivity to bortezomib, boron or mannitol
pregnant or lactating status, confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Contact the study team to confirm eligibility.

Intervention Hierarchy (Ancestors)

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

Study Completion

April 2009

Actual (reported)

Last Updated

July 22, 2009

Record last verified: 2009-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00210327
Data provider: ClinicalTrials.gov
Source updated: 2009-07-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:48 UTC

Locations

CH(1)

VELCADE in MALT Lymphoma Pretreated With Prior Systemic Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations