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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210392
Recruitment Status : Terminated (After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study)
First Posted : September 21, 2005
Last Update Posted : March 30, 2015
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

Intervention Details:
  • Drug: Bortezomib (drug)
    Bortezomib 1,3 mg/m2 iv d1,4,8,11 every 21 days. Total 6 cycles

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety, as acute and long-term toxicity [ Time Frame: 18 months after treatment completion ]
  2. Response duration (RD) (time to relapse or progression) in responders [ Time Frame: 18 months after treatment completion ]
  3. Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients [ Time Frame: 18 months after study completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210392

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

Additional Information:
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Responsible Party: International Extranodal Lymphoma Study Group (IELSG), IELSG Identifier: NCT00210392     History of Changes
Other Study ID Numbers: IELSG25B
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents