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.
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Oystein Bruserud, MD
University of Bergen, Norway
Norway: Norwegian Medicines Agency
Rek VEST 231-06