Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
28/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 approved on the 30th April 2003 (ref: 03/1/031). Amendment approved on the 30th October 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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes