Differentiation Induction in Acute Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Øystein Bruserud, University of Bergen
ClinicalTrials.gov Identifier:
NCT00175812
First received: September 9, 2005
Last updated: June 23, 2015
Last verified: June 2015

September 9, 2005
June 23, 2015
November 2004
May 2008   (final data collection date for primary outcome measure)
Survival [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
Survival
Complete list of historical versions of study NCT00175812 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disease stabilisation
  • Disease complications
  • Side effects of therapy
Not Provided
Not Provided
 
Differentiation Induction in Acute Myelogenous Leukemia
Differentiation Induction Therapy for Acute Myelogenous Leukemia

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.

Patients to be included:

  1. Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
  2. 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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myelogenous Leukemia
  • Drug: all-trans retinoic acid (ATRA)
    All-trans retinoic acid 22.5 mg/square meter twice daily days 1-14
  • Drug: Valproic acid
    Valproic acid, highest dose without side effects from day 3 until progression
  • Drug: Theophyllin
    Theophyllin, targetted serum level 50-100 from day 3 until progression
Experimental: ATRA plus valproic acid plus theophyllin
ATRA for 14 days, continuous treatment with valproic acid and theophyllin
Interventions:
  • Drug: all-trans retinoic acid (ATRA)
  • Drug: Valproic acid
  • Drug: Theophyllin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00175812
REK-Vestnr21503
No
Øystein Bruserud, University of Bergen
University of Bergen
Not Provided
Principal Investigator: Oystein Bruserud, MD University of Bergen
University of Bergen
June 2015

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