Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine

Acute Myelogenous Leukemia

Acute myelogenous leukemia, all-trans retinoic acid, valproic acid, cytarabine, Disease stabilization, survival, toxicity

Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment. Adult patients \>18 years of age who can be included: Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Treatment: Combined therapy with: Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.

Patients to be included: 1. Elderly patients (\>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML). 2. Adult patients of any age (\>18 years of age) with relapsed or resistant AML who cannot receive conventional therapy. Treatment: Valproic acid to be started on day 1 as continuous therapy until disease progression. ATRA administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month. Low-dose cytarabine 10 mg/m2 from day 14 and continued as daily injections for up to 10 days, repeated every third month. Supportive therapy is given according to the hospitals general guidelines. Followup: The first 2 days treatment in hospital, later regular out-patient treatment. Controls will include clinical examination, peripheral blood parameters (including serum valproic acid levels), bone marrow samples.

Norway