NCT00995332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

3.4 years

First QC Date

October 14, 2009

Last Update Submit

June 23, 2015

Conditions

Acute Myelogenous Leukemia

Keywords

Acute myelogenous leukemiaall-trans retinoic acidvalproic acidcytarabineDisease stabilizationsurvivaltoxicity

Outcome Measures

Primary Outcomes (1)

  • Survival

    3 years

Secondary Outcomes (3)

  • Disease stabilization

    3 years

  • Disease complications

    3 years

  • Side effects of therapy

    3 years

Study Arms (1)

ATRA+valproc acid+low-dose cytarabine

EXPERIMENTAL
Drug: Cytarabine, all-trans retinoic acid, valproic acid

Interventions

Cytarabine, all-trans retinoic acid, valproic acidDRUG

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
ATRA+valproc acid+low-dose cytarabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recently diagnosed AML in patients unfit for intensive chemotherapy
  • Patients with relapsed or refractory AML

You may not qualify if:

  • No informed consent
  • Intolerance to study drugs
  • Serious liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital and University of Bergen

Bergen, N-5021, Norway

Location

Related Publications (3)

  • Fredly H, Ersvaer E, Kittang AO, Tsykunova G, Gjertsen BT, Bruserud O. The combination of valproic acid, all-trans retinoic acid and low-dose cytarabine as disease-stabilizing treatment in acute myeloid leukemia. Clin Epigenetics. 2013 Aug 1;5(1):13. doi: 10.1186/1868-7083-5-13.

    PMID: 23915396BACKGROUND

  • Haaland I, Hjelle SM, Reikvam H, Sulen A, Ryningen A, McCormack E, Bruserud O, Gjertsen BT. p53 Protein Isoform Profiles in AML: Correlation with Distinct Differentiation Stages and Response to Epigenetic Differentiation Therapy. Cells. 2021 Apr 7;10(4):833. doi: 10.3390/cells10040833.

    PMID: 33917201DERIVED

  • Reikvam H, Hovland R, Forthun RB, Erdal S, Gjertsen BT, Fredly H, Bruserud O. Disease-stabilizing treatment based on all-trans retinoic acid and valproic acid in acute myeloid leukemia - identification of responders by gene expression profiling of pretreatment leukemic cells. BMC Cancer. 2017 Sep 6;17(1):630. doi: 10.1186/s12885-017-3620-y.

    PMID: 28877686DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CytarabineTretinoinValproic Acid

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Oystein Bruserud, MD

    University of Bergen, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

NO(1)