Differentiation Induction in Acute Myelogenous Leukemia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

February 27, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Survival

Change History

Complete list of historical versions of study NCT00175812 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disease stabilisation [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
Disease complications [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
Side effects of therapy [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Disease stabilisation
Disease complications
Side effects of therapy

Descriptive Information

Brief Title ^ICMJE

Differentiation Induction in Acute Myelogenous Leukemia

Official Title ^ICMJE

Differentiation Induction Therapy for Acute Myelogenous Leukemia

Brief Summary

Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia.

Adult patients (<18 years of age) who can be included: Elderly patients (>60 years of age) with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Patients with relapsed or resistant AML who cannot receive intensive chemotherapy.

Treatment: Patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). Duration of treatment at least 2 months or until disease progression. Maximal duration of treatment 2 years.

Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.

Detailed Description

Patients to be included:

Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
Adult patients of any age (> 18 years of age)with relapsed or resistant AML who cannot receive conventional intensive chemotherapy or allogeneic stem cell transplantation.

We plan to include at least 20 patients, but if possible 30 patients during a 3 years period. The first patient was included November 2004.

Treatment:

All-trans retinoic acid (ATRA) administered orally 22.5 mg/m2 twice daily for 14 days, repeated every third month.

Valproic acid started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Theophyllamine started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Duration of treatment at least 2 months unless side effects,until disease progression or an overall duration of treatment of 2 years.

Supportive therapy according to the hospitals general guidelines.

Followup:

The first week treatment in hospital. Later out-patient treatment with regular controls including clinical examination, peripheral blood parameters (including serum valproic acid and theophyllamin levels), bone marrow samples.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acute Myelogenous Leukemia

Intervention ^ICMJE

Drug: all-trans retinoic acid (ATRA)
Drug: Valproic acid
Drug: Theophyllin

Study Arms / Comparison Groups

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2009

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Recently diagnosed acute myelogenous leukemia (AML)
Patients above 60 years of age
Patients who cannot receive conventional chemotherapy
Patients with relapsed or refractory AML independent of age

Exclusion Criteria:

Chronic myelogenous leukemia in blast phase
Intolerance to the study drugs
Serious liver disease
No informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00175812

Responsible Party

Professor Øystein Bruserud, Haukeland University Hospital

Study ID Numbers ^ICMJE

REK-Vestnr21503

Study Sponsor ^ICMJE

University of Bergen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Oystein Bruserud, MD

University of Bergen

Information Provided By

University of Bergen

Verification Date

February 2009

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