Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach

Basic Trial Information

Objectives

I.   Determine the efficacy and response rate of triple antibiotic therapy for 
Helicobacter pylori in the healing of lesions in patients with low grade 
gastric lymphoma.

II.  Assess the efficacy of chlorambucil in the prevention of relapse in 
patients after complete eradication of low grade gastric lymphoma.

III. Determine the natural history of unresected or partially resected low 
grade gastric lymphoma treated medically.

Entry Criteria

Disease Characteristics:

Endoscopically diagnosed, unresected, partially resected, or completely
resected low grade (stage I) gastric lymphoma

Prior diagnosis of H. pylori infection

No nodal metastases

Microbiological evidence of current H. pylori infection required

No pathological evidence of enlarged abdominal lymph nodes by CT scan
 Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 See Disease Characteristics

Patient Characteristics:

Age:
 16 and over

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Expected Enrollment

A total of 200 patients will be accrued for this study.

Outline

This is a randomized study.  Patients are randomized to receive chlorambucil 
or placebo.

Patients receive omeprazole daily for 1 week.  Clarithromycin and tinidazole 
are administered twice daily for 1 week for the eradication of H. pylori 
infection.  Patients are assessed every 2-3 months by endoscopy.  Patients may 
receive a maximum of 3 courses of treatment every 2-3 months.  Other regimens 
may be used if full eradication of H. pylori is not achieved.

Patients who achieve complete response (eradication of H. pylori) are 
randomized to receive oral chlorambucil or placebo daily for 14 days.  
Treatment is repeated every 28 days for 6 courses.

Patients are followed every 6 months for 2 years, then yearly thereafter.

Hancock BW, Qian W, Linch D, et al.: Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial. Br J Haematol 144 (3): 367-75, 2009.[PUBMED Abstract]

Bertoni F, Conconi A, Capella C, et al.: Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 cooperative trial. Blood 99 (7): 2541-4, 2002.[PUBMED Abstract]

Zucca E, Roggero E, Delchier J, et al.: Interim evaluation of gastric malt lymphoma response to antibiotics in the ongoing LY03 randomized cooperative trial of observation vs chlorambucil after anti-helicobacter therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A12, 2000.

Trial Contact Information

Trial Lead Organizations

Lymphoma Trials Office

Barry Hancock, MD, Protocol chair		Ph: 44-114-226-5000 ext. 5007 Email: b.w.hancock@sheffield.ac.uk

Registry Information
Official Title		Protocol for a Randomised Trial of Observation Versus Chlorambucil After Anti-Helicobacter Therapy in Low Grade Gastric Lymphoma
Trial Start Date		1995-03-01
Registered in ClinicalTrials.gov		NCT00003617
Date Submitted to PDQ		1998-10-05
Information Last Verified		2009-04-23

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