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

ISRCTN	ISRCTN53211392
DOI	https://doi.org/10.1186/ISRCTN53211392
Secondary identifying numbers	SNLG NHLVIII

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 30/11/2015

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1995
Completion date	30/06/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	30/06/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Scotland & Newcastle Lymphoma Group (UK)
Research organisation

Medical Statistics Unit, Department of Public Health Sciences
University of Edinburgh
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom

Phone	+44 (0)131 650 4382
Email	jim.wilson@ed.ac.u

Funders

Funder type

Research organisation

Scottish & Newcastle Lymphoma 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?
Results article	results	01/11/2006		Yes	No

Editorial Notes

30/11/2015: Publication reference added.