Differentiation Induction in 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.
Acute Myelogenous Leukemia
Drug: all-trans retinoic acid (ATRA)
Drug: Valproic acid
|Study Design:||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|
- Survival [ Time Frame: 2008 ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||November 2004|
|Study Completion Date:||November 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: ATRA plus valproic acid plus theophyllin
ATRA for 14 days, continuous treatment with valproic acid and theophyllin
Drug: all-trans retinoic acid (ATRA)
All-trans retinoic acid 22.5 mg/square meter twice daily days 1-14Drug: Valproic acid
Valproic acid, highest dose without side effects from day 3 until progressionDrug: Theophyllin
Theophyllin, targetted serum level 50-100 from day 3 until progression
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175812
|Haukeland University Hospital, University of Bergen|
|Bergen, Norway, N-5021|
|Principal Investigator:||Oystein Bruserud, MD||University of Bergen|