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

This study has been terminated.
(After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study)
Sponsor:
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210392
First received: September 13, 2005
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Lymphoma, Mucosa-Associated Lymphoid Tissue
Drug: Bortezomib (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-Cell Lymphoma of MALT-Type Pretreated With More Than One Prior Systemic Therapy Regimen (X05142)

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses [ Time Frame: During treatment and one month after treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, as acute and long-term toxicity [ Time Frame: 18 months after treatment completion ] [ Designated as safety issue: Yes ]
  • Response duration (RD) (time to relapse or progression) in responders [ Time Frame: 18 months after treatment completion ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients [ Time Frame: 18 months after study completion ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2005
Study Completion Date: November 2007
Estimated Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bortezomib (drug)
    Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles
  Eligibility

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

Inclusion Criteria:

  1. histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
  2. any stage (Ann Arbor I-IV)
  3. relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or anti-CD20 immunotherapy
  4. no evidence of histologic transformation to a high grade lymphoma
  5. measurable or evaluable disease
  6. age > 18 years
  7. full recovery from previous therapy, with life expectancy of at least 6 months
  8. ECOG performance status 0-2
  9. for primary gastric localized H. pylori-positive disease at diagnosis:

    1. persistent disease 1 year after documented H. pylori infection eradication
    2. clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication
  10. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
  11. 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
  12. 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
  13. no evidence of active opportunistic infections
  14. no known HIV infection
  15. no active HBV and/or HCV infection
  16. no serious medical illness likely to interfere with participation in this clinical study
  17. voluntary written informed consent before performance of any study-related procedure
  18. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study

Exclusion Criteria:

  1. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1. (CIN1) or localized non-melanomatous skin cancer
  2. other investigational drugs with 14 days before enrollment
  3. evidence of symptomatic central nervous system (CNS) disease
  4. severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement
  5. evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment
  6. known hypersensitivity to bortezomib, boron or mannitol
  7. 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
  8. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210392

Locations
Switzerland
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
Study Chair: Franco Cavalli International Extranodal Lymphoma Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: International Extranodal Lymphoma Study Group (IELSG), IELSG
ClinicalTrials.gov Identifier: NCT00210392     History of Changes
Other Study ID Numbers: IELSG25B
Study First Received: September 13, 2005
Last Updated: July 21, 2009
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014