A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Combined modality therapy in PCNSL has improved survival outcomes but at the cost of
unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has
activity in systemic lymphomas and crosses the blood brain barrier and may add to the
efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy
survival outcomes should be optimal but with lower rates of neurotoxicity.
Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose
radiotherapy and this will allow comparison of survival and neurotoxicity rates.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the median and 2 year overall survival.
Estimate of survival at 2 years and at 5 years.
Peter O'Brien, FRANZCR
Newcastle Mater Misericordiae Hospital
Australia: Department of Health and Ageing Therapeutic Goods Administration