Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SNLG NHLVIII

Study information

Scientific title

Randomised Controlled Trial of CID versus CD for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma and Randomised Controlled Assessment of Interferon as Maintenance Treatment after Remission Induction

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lymphoma (non-Hodgkin's)

Intervention

INDUCTION / CONSOLIDATION:
Patients are randomised to one of two treatment arms:
1. Arm A: Chemotherapy with Chlorambucil, idarubicin and dexamethasone (CID), cycle to be repeated every 21 days. Patients showing a response following three courses will receive three further consolidation courses.
2. Arm B: Chemotherapy with Chlorambucil and dexamethasone (CD), cycle to be repeated every 21 days. Patients showing a response following three courses will receive three further consolidation courses.

RADIOTHERAPY: Patients may be given localised radiotherapy to initial areas of bulky disease if a complete response in that particular site has not been obtained following induction.

MAINTENANCE: Patients who have shown a complete response or good partial response following six cycles of induction therapy are eligible for the second randomisation. Patients are randomised to one of three groups:
1. Group A: No further therapy.
2. Group B: Low dose interferon, 1MU subcutaneously three times a week until progression or maximum of 36 months.
3. Group C: High dose interferon, 3MU subcutaneously three times a week until progression or maximum of 36 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1995

Overall trial end date

30/06/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Kiel classification of low grade non-Hodgkin's lymphoma
2. Stages II to IV
3. Age 15 to 70 years
4. Measurable disease
5. No prior chemotherapy
6. No central nervous system (CNS) involvement
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
8. Adequate bone marrow, renal and hepatic function
9. No medical contraindications to protocol treatments

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1995

Recruitment end date

30/06/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Scotland & Newcastle Lymphoma Group (UK)

Sponsor details

Medical Statistics Unit
Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
+44 (0)131 650 4382
jim.wilson@ed.ac.u

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Scottish & Newcastle Lymphoma 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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17107904

Publication citations

Additional files

Editorial Notes

30/11/2015: Publication reference added.