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Status:

COMPLETED

Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

Lead Sponsor:

International Extranodal Lymphoma Study Group (IELSG)

Conditions:

Lymphoma, Mucosa-Associated Lymphoid Tissue

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome o...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
  • any stage (Ann Arbor I-IV)
  • either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
  • no evidence of histologic transformation to a high grade lymphoma
  • measurable or evaluable disease
  • age \> 18
  • life expectancy of at least 1 year
  • ECOG performance status 0-2
  • no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
  • no prior chemotherapy
  • no prior immunotherapy with any anti-CD20 monoclonal antibody
  • no prior radiotherapy in the last 6 weeks
  • no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms
  • no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
  • no evidence of symptomatic central nervous system (CNS) disease
  • no impairment of bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement
  • no major impairment of renal function (serum creatinine \<1,5x upper normal) or liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement
  • no evidence of active opportunistic infections
  • no known HIV infection
  • no active HBV and/or HCV infection
  • no pregnant or lactating status
  • appropriate contraceptive method in women of childbearing potential or men
  • absence of 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
  • informed consent must be given according to national/local regulations before randomization

Exclusion

    Key Trial Info

    Start Date :

    January 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 17 2016

    Estimated Enrollment :

    454 Patients enrolled

    Trial Details

    Trial ID

    NCT00210353

    Start Date

    January 1 2003

    End Date

    February 17 2016

    Last Update

    June 6 2019

    Active Locations (75)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (75 locations)

    1

    ACZA Campus Stuivenberg

    Antwerp, Belgium

    2

    AZ StJan

    Bruges, Belgium

    3

    St Luc

    Brussels, Belgium

    4

    ULB Hopital Erasme

    Brussels, Belgium