Topic: National Cancer Research Network
Conditions
Interventions
ARM A: Chlorambucil 6 mg/m2 daily orally (p.o.) for 42 consecutive days (weeks 1 - 6)
ARM B: Chlorambucil 6 mg/m2 daily p.o. for 42 consecutive days (weeks 1 - 6) and rituximab 375 mg/m2 intravenous (
Sponsors
Southampton University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this trial, patients must fulfill all the following criteria: 1. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site 2. Any stage (Ann Arbor I - IV) 3. Either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) 4. No evidence of histologic transformation to a high grade lymphoma 5. Measurable or evaluable disease 6. Aged greater than 18 years 7. Life expectancy of at least 1 year 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 9. No prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localised non-melanomatous skin cancer 10. No prior chemotherapy 11. No prior immunotherapy with any anti-CD20 monoclonal antibody 12. No prior radiotherapy in the last 6 weeks 13. No corticosteroids during the last 28 days, unless prednisone chronically administered at a dose less than 20 mg/day for indications other than lymphoma or lymphoma-related symptoms 14. No evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhytmias, congestive heart failure or myocardial infarction within 12 months before study entry 15. No evidence of symptomatic central nervous system (CNS) disease 16. No impairment of bone marrow function (white blood cells [WBC] greater than 3.0 x 10^9/L, absolute neutrophil count [ANC] greater than 1.5 x 10^9/L, platelets [PLT] greater than 100 x 10^9/L), unless due to lymphoma involvement 17. No major impairment of renal function (serum creatinine less than 1.5 x upper normal) or liver function (aspartate aminotransferase [ASAT]/alanine aminotransferase [ALAT] less than 2.5 upper normal, total bilirubin less than 2.5 x upper normal), unless due to lymphoma involvement 18. No evidence of active opportunistic infections 19. No known human immunodeficiency virus (HIV) infection 20. No active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection 21. No pregnant or lactating status 22. Appropriate contraceptive method in women of childbearing potential or men 23. 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 24. Informed consent must be given according to national/local regulations before randomisation
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free-survival (EFS) (failure or death from any cause) for all patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete and partial remission rates for all patients 2. Response duration (time to relapse or progression) for responder patients 3. Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients 4. Overall survival for all patients 5. Acute and long-term toxicity | — |
Countries
United Kingdom
Outcome results
None listed