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

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ClinicalTrials.gov Identifier: NCT00995332
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : June 24, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Cytarabine, all-trans retinoic acid, valproic acid Phase 1 Phase 2

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.


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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Primary Completion Date : February 2013
Study Completion Date : June 2013

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Disease stabilization [ Time Frame: 3 years ]
  2. Disease complications [ Time Frame: 3 years ]
  3. Side effects of therapy [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995332

Haukeland University Hospital and University of Bergen
Bergen, Norway, N-5021
Sponsors and Collaborators
University of Bergen
Study Chair: Oystein Bruserud, MD University of Bergen, Norway
More Information

Responsible Party: Øystein Bruserud, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00995332     History of Changes
Other Study ID Numbers: Rek VEST 231-06
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Øystein Bruserud, University of Bergen:
Acute myelogenous leukemia
all-trans retinoic acid
valproic acid
Disease stabilization

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Valproic Acid
Histone Deacetylase Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Keratolytic Agents
Dermatologic Agents