Contact information
Type
Scientific
Primary contact
Mrs Louisa Little
ORCID ID
Contact details
MP131
University of Southampton Clinical Trials Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 23 8120 5331
lal@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1294
Study information
Scientific title
Multi-centre randomised trial of chlorambucil versus chlorambucil plus rituximab versus rituximab alone in extranodal marginal zone b-cell lymphoma of mucosa associated lymphoid tissue (malt lymphoma)
Acronym
IELSG19/MALT Trial
Study hypothesis
The aim of the study is to assess the therapeutic activity and the safety of the combination of chlorambucil and rituximab in mucosa associated lymphoid tissue (MALT) lymphomas and to determine whether the addition of ritxuiamb to chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with chlorambucil alone. Also to compare the anti-tumor activity and safety of rituximab alone versus chlorambucil alone.
Ethics approval
South East Multi-Centre Research Ethics Committee, 30/04/2003 (ref: 03/1/031). Amendment approved on the 30/10/2006.
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's)
Intervention
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 (iv) on days 1, 8, 15, 22 during the first month (4 weekly doses)
ARM C: Rituximab 375 mg/m2 iv on days 1, 8, 15, 22 during the first month (4 weekly doses)
Study entry: single randomisation only
Intervention type
Drug
Phase
Phase III
Drug names
Chlorambucil, rituximab
Primary outcome measure
Event-free-survival (EFS) (failure or death from any cause) for all patients
Secondary outcome measures
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
Overall trial start date
01/08/2003
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 450
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/08/2003
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MP131, University of Southampton Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
International Extranodal Lymphoma Study Group (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list