Trial Information

Randomised Controlled Trial of CID (Chlorambucil, Idarubicin, Dexamethasone) Versus CD (Chlorambucil, Dexamethasone) for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma (Kiel Classification) Followed by Randomised Controlled Assessment of Standard Dose Interferon Versus Low Dose Interferon Versus No Further Therapy as Maintenance Treatment After Remission Induction

OBJECTIVES: I. Compare the remission induction rates and toxicity of chlorambucil plus
dexamethasone with or without idarubicin in patients with stage II-IV low grade
non-Hodgkin's lymphoma. II. Assess the additional value of a period of
consolidation/maintenance treatment utilizing low dose interferon alfa or standard dose
interferon alfa versus no further treatment in relationship to the duration of event-free
survival in these patients.

OUTLINE: This is a randomized, open label, controlled, multicenter study. Patients are
randomized into one of two arms for induction chemotherapy. Arm I: Patients receive oral
chlorambucil three times daily for 3 consecutive days, oral idarubicin daily for 3
consecutive days, and oral dexamethasone twice daily for 5 consecutive days every 21 days.
Arm II: Patients receive oral chlorambucil three times daily for 3 consecutive days and oral
dexamethasone twice daily for 5 consecutive days every 21 days. Treatment for both arms
continues for up to 6 courses in the absence of disease progression or unacceptable
toxicity. After 6 courses of chemotherapy, patients are reassessed. If they have achieved
maximal complete response or good partial response, patients are randomized into one of
three arms. Arm I: Patients receive no further treatment until disease progresses. Arm II:
Patients receive low dose interferon alfa subcutaneously three times per week for a maximum
of 3 years in the absence of disease progression. Arm III: Patients receive standard dose
interferon alfa subcutaneously three times a week for a maximum of 3 years in the absence of
disease progression. Patients are followed every 8-12 weeks for 3 years.

PROJECTED ACCRUAL: There will be 200 patients accrued into this study with approximately 150
patients entering the second phase of this study.