VELCADE in MALT Lymphoma Pretreated With More Than One Prior Systemic Therapy

NCT00210392 | Terminated Phase 2 DMC

• 1 other identifier: IELSG25B
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 more than one prior systemic therapy regimen

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

  During treatment and one month after treatment completion

Secondary Outcomes (3)

• Safety, as acute and long-term toxicity

  18 months after treatment completion

• Response duration (RD) (time to relapse or progression) in responders

  18 months after treatment completion

• Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients

  18 months after study completion

Interventions

Bortezomib (drug) DRUG

Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
• any stage (Ann Arbor I-IV)
• relapsed or refractory disease pretreated with \> 1 prior chemotherapy regimen and/or anti-CD20 immunotherapy
• 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

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 with 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

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Bortezomib; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Franco Cavalli

  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 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

CH (1)