Combined Therapy With Valproic Acid, All-trans Retinoic Acid (ATRA) and Cytarabine in Human Acute Myelogenous Leukemia (AML) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 14, 2009

Last Updated Date

October 14, 2009

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Disease stabilization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Disease complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Side effects of therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Combined Therapy With Valproic Acid, All-trans Retinoic Acid (ATRA) and Cytarabine in Human Acute Myelogenous Leukemia (AML)

Official Title ^ICMJE

Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine

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:

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.

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Acute Myelogenous Leukemia

Intervention ^ICMJE

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

Study Arms / Comparison Groups

ATRA+valproc acid+low-dose cytarabine: Experimental

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Oystein Bruserud, MD

+47 55 97 29 97

oystein.bruserud@haukeland.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00995332

Responsible Party

Professor Oystein Bruserud, University of Bergen and Haukeland University Hospital

Study ID Numbers ^ICMJE

Rek VEST 231-06

Study Sponsor ^ICMJE

University of Bergen

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

University of Bergen

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP