Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
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.
|Acute Myelogenous Leukemia||Drug: Cytarabine, all-trans retinoic acid, valproic acid||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine|
- Survival [ Time Frame: 3 years ]
- Disease stabilization [ Time Frame: 3 years ]
- Disease complications [ Time Frame: 3 years ]
- Side effects of therapy [ Time Frame: 3 years ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: ATRA+valproc acid+low-dose cytarabine||
Drug: Cytarabine, all-trans retinoic acid, valproic acid
ATRA: 22.5 mg/m2 twice daily for 2 weeks every third month Valproic acid: continuous therapy, dosage guided by serum levels Cytarabine: 10 mg/m2 once daily for up to 10 days every third month
Other Name: No other names
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995332
|Haukeland University Hospital and University of Bergen|
|Bergen, Norway, N-5021|
|Study Chair:||Oystein Bruserud, MD||University of Bergen, Norway|