Overview

This trial is active, not recruiting.

Condition lymphoma, mucosa-associated lymphoid tissue
Treatments chlorambucil (drug), rituximab+chlorambucil, rituximab
Phase phase 3
Target CD20
Sponsor International Extranodal Lymphoma Study Group (IELSG)
Start date January 2003
End date June 2017
Trial size 450 participants
Trial identifier NCT00210353, IELSG19

Summary

Aim of the study is to assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and to determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.

In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
chlorambucil (drug)
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
(Experimental)
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
rituximab+chlorambucil
rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
(Experimental)
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
rituximab
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Primary Outcomes

Measure
Event-free-survival (EFS) (failure or death from any cause) for all patients
time frame: 5 years

Secondary Outcomes

Measure
Complete and partial remission rates for all patients
time frame: end of treatment
Response duration (time to relapse or progression) for responder patients
time frame: 5 years
Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients
time frame: 5 years
Overall survival for all patients
time frame: 5 years
Acute and long-term toxicity
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion 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. age > 18 7. life expectancy of at least 1 year 8. ECOG performance status 0-2 9. no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized 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 <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 arrhythmias, 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 (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement 17. 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 18. no evidence of active opportunistic infections 19. no known HIV infection 20. no active HBV and/or 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 randomization

Additional Information

Official title Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by International Extranodal Lymphoma Study Group (IELSG).