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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17107904