Trial Information

Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine

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.