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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2002
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. CONDITION: Lymphoma (non‐Hodgkin's) ; Cancer PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: 1f524e5f04b408494d010ebc47b0c078f6018ce8
First added on: Aug 21, 2024