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
Protocol serial number SNLG NHLVIII
Sponsor Scotland & Newcastle Lymphoma Group (UK)
Funder Scottish & Newcastle Lymphoma Group (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleRandomised 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedLymphoma (non-Hodgkin's)
InterventionINDUCTION / 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 typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/06/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1995
Date of final enrolment30/06/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

30/11/2015: Publication reference added.

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