A Phase 1/2 interventional study of Cytarabine, all-trans retinoic acid, valproic acid in Acute Myelogenous Leukemia, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by University of Bergen · Phase 1/2, Interventional, and Treatment
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.
Patients to be included:
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 36 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: No other names
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
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Bergen