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:
- The complete histological and molecular remission rate for antibiotics as 1st-line therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma
- The durability of complete histological remission after antibiotics
- 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
- The frequency of t(11;18) translocation in gastric lg- and hg-MALT lymphoma in Taiwan.
- 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
- The complete histological and molecular remission rate for antibiotics as 1st-line therapy for Hp-positive early-stage gastric lg- and hg-MALT lymphoma
- The durability of complete histological remission after antibiotics
- 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