Differentiation Induction in Acute Myelogenous Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Bergen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00175812
First received: September 9, 2005
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: all-trans retinoic acid (ATRA)
Drug: Valproic acid
Drug: Theophyllin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Differentiation Induction Therapy for Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Survival [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2004
Estimated Study Completion Date: November 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175812

Locations
Norway
Haukeland University Hospital, University of Bergen
Bergen, Norway, N-5021
Sponsors and Collaborators
University of Bergen
Investigators
Principal Investigator: Oystein Bruserud, MD University of Bergen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Øystein Bruserud, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00175812     History of Changes
Other Study ID Numbers: REK-Vestnr21503
Study First Received: September 9, 2005
Last Updated: February 27, 2009
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Bergen:
Acute myelogenous leukemia
Differentiation
All trans retinoic acid
Valproic acid
Theophyllamin

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Theophylline
Tretinoin
Valproic Acid
Anti-Asthmatic Agents
Anticonvulsants
Antimanic Agents
Antineoplastic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Enzyme Inhibitors
GABA Agents
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Purinergic Agents
Purinergic Antagonists

ClinicalTrials.gov processed this record on October 29, 2014