Clinical Trial: Prospective Study of First-line Antibiotic Therapy for Early-stage Gastric MALT Lymphoma for Treatment Outcome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicentre,Prospective Study of First-line Antibiotic Therapy for Early-stage Low-grade and High-grade Gastric Mucosa-associated Lymphoid Tissue-type Lymphoma and Potential Predicting Factor for Trea

Brief Summary:

  1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma
  2. The durability of complete histological remission after antibiotics
  3. The usefulness of pattern of NF-kB and BCL-10 by IHC staining in prospectively predicting the Hp-dependence of gastric lg- and hg-MALT lymphoma
  4. The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.
  5. The association between the CYP2C18/19 genetic polymorphisms and eradication of Hp infection after antibiotics.

Detailed Summary:

Background: Eradication of Helicobacter pylori (Hp) infection is well recognized as the initial therapy for early-stage low-grade gastric mucosa-associated lymphoid tissue-type lymphoma (lg-MALT lymphoma). On the other hand, high-grade transformed MALT lymphoma (hg-MALT lymphoma) is generally considered to arise from Hp-independent clones and thus to be unlikely to respond to antibiotic therapy. Our previous prospective studies have firstly demonstrated that 1st-line antibiotic therapy could achieve durable complete histological remission in two-third of Hp-positive stage IE hg-MALT lymphoma (Chen et al., J. Clin. Oncol., 2001), in which the long-term clinical outcomes were equivalent to those achievable in lg-MALT lymphoma (Chen et al. J Natl Cancer Inst, accepted). In addition, our laboratory studies have confirmed that t(11;18) translocation is associated with loss of Hp-dependence in lg-MALT lymphoma but infrequently found in high-grade tumors. We also found that nuclear translocation of NF-kB or BCL-10 (by immunohistochemical, IHC, staining) were useful markers to predict the Hp-dependence of both early-stage gastric hg- and lg-MALT lymphoma to antibiotic therapy (Kuo et al. JCO 2004 & Yeh et al. Blood 2005). In addition, recent data suggested cytochrome CYP2C18/19 genetic polymorphisms are associated with the metabolism of omeprazole, and thus the genotype of such enzymes might affect the efficacy of antibiotics for eradication of Hp infection.

Aims: A nationwide study to prospectively validate

  1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma
  2. The durability of complete histological remission after antibiotics
  3. Th
    Sponsor: National Health Research Institutes, Taiwan

    Current Primary Outcome: Hp eradication rate and complete histological rate [ Time Frame: 10 years ]

    Original Primary Outcome: Hp eradication rate and complete histological rate

    Current Secondary Outcome: overall survival (OS)Relapse-free survival (RFS) [ Time Frame: 10 years ]

    Original Secondary Outcome: overall survival (OS)Relapse-free survival (RFS)

    Information By: National Health Research Institutes, Taiwan

    Dates:
    Date Received: May 17, 2006
    Date Started: July 2006
    Date Completion:
    Last Updated: March 23, 2016
    Last Verified: March 2016