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

Phase 1

Completed

• Conditions: Acute Myelogenous Leukemia
• Interventions: Drug: Cytarabine, all-trans retinoic acid, valproic acid

• Registration Number: NCT00995332
• Lead Sponsor: University of Bergen

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:

1. Elderly patients (\>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).

2. 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.

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Primary Completion: 2013-02
• Study Completion: 2013-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATRA+valproc acid+low-dose cytarabine	Cytarabine, all-trans retinoic acid, valproic acid	-

Primary Outcome Measures

Name	Time	Method
Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Disease complications	3 years
Disease stabilization	3 years
Side effects of therapy	3 years

Trial Locations

Locations (1)

Haukeland University Hospital and University of Bergen; 🇳🇴 Bergen, Norway