Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Survival
Study Overview
Brief 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.
Detailed Description
Patients to be included:
- Elderly patients (>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ATRA+valproc acid+low-dose cytarabine
Intervention: Cytarabine, all-trans retinoic acid, valproic acid (Drug)
Outcomes
Primary Outcomes
Survival
Time Frame: 3 years
Secondary Outcomes
- Disease complications(3 years)
- Disease stabilization(3 years)
- Side effects of therapy(3 years)
Investigators
Øystein Bruserud
Professor
University of Bergen