Differentiation Induction in Acute Myelogenous Leukemia

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia.

Adult patients (<18 years of age) who can be included: Elderly patients (>60 years of age) with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Patients with relapsed or resistant AML who cannot receive intensive chemotherapy.

Treatment: Patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). Duration of treatment at least 2 months or until disease progression. Maximal duration of treatment 2 years.

Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Bergen
• Treatments: Theophylline; Tretinoin; Valproic Acid

Criteria

Inclusion Criteria:

• Recently diagnosed acute myelogenous leukemia (AML)

• Patients above 60 years of age

• Patients who cannot receive conventional chemotherapy

• Patients with relapsed or refractory AML independent of age

Exclusion Criteria:

• Chronic myelogenous leukemia in blast phase

• Intolerance to the study drugs

• Serious liver disease

• No informed consent