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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bergen
• Treatments: Cytarabine; Histone Deacetylase Inhibitors; Tretinoin; Valproic Acid

Criteria

Inclusion Criteria:

• Recently diagnosed AML in patients unfit for intensive chemotherapy

• Patients with relapsed or refractory AML

Exclusion Criteria:

• No informed consent

• Intolerance to study drugs

• Serious liver disease