Differentiation Induction Therapy for Acute Myelogenous Leukemia
Patients to be included:
1. Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia
(AML) who cannot receive conventional intensive chemotherapy.
2. Adult patients of any age (> 18 years of age)with relapsed or resistant AML who cannot
receive conventional intensive chemotherapy or allogeneic stem cell transplantation.
We plan to include at least 20 patients, but if possible 30 patients during a 3 years
period. The first patient was included November 2004.
All-trans retinoic acid (ATRA) administered orally 22.5 mg/m2 twice daily for 14 days,
repeated every third month.
Valproic acid started on day 3 of ATRA therapy, the first week as intravenous administration
and later oral administration.
Theophyllamine started on day 3 of ATRA therapy, the first week as intravenous
administration and later oral administration.
Duration of treatment at least 2 months unless side effects,until disease progression or an
overall duration of treatment of 2 years.
Supportive therapy according to the hospitals general guidelines.
The first week treatment in hospital. Later out-patient treatment with regular controls
including clinical examination, peripheral blood parameters (including serum valproic acid
and theophyllamin 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: Norwegian Medicines Agency