Chlorambucil versus chlorambucil plus rituximab versus rituximab alone in malt lymphoma

ISRCTN	ISRCTN11144129
DOI	https://doi.org/10.1186/ISRCTN11144129
Secondary identifying numbers	1294

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-chlorambucil-alone-rituximab-alone-or-chlorambucil-and-rituximab-together-for-malt-lymphoma

Contact information

Mrs Louisa Little
Scientific

MP131, University of Southampton Clinical Trials Unit
Tremona Road
Southampton
SO16 6YD
United Kingdom

Phone	+44 23 8120 5331
Email	lal@soton.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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)
Study acronym	IELSG19/MALT Trial
Study objectives	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(s)	South East Multi-Centre Research Ethics Committee, 30/04/2003 (ref: 03/1/031). Amendment approved on the 30/10/2006.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	01/08/2003
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 450
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/08/2003
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

MP131, University of Southampton Clinical Trials Unit

Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Website	http://www.soton.ac.uk/
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Research organisation

International Extranodal Lymphoma Study Group (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
12/12/2017: No publications found in PubMed, verifying study status with principal investigator.