Differentiation Induction in Acute Myelogenous Leukemia
Information source: University of Bergen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myelogenous Leukemia
Intervention: all-trans retinoic acid (ATRA) (Drug); Valproic acid (Drug); Theophyllin (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: University of Bergen Official(s) and/or principal investigator(s): Oystein Bruserud, MD, Principal Investigator, Affiliation: University of Bergen
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.
Clinical Details
Official title: Differentiation Induction Therapy for Acute Myelogenous Leukemia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Survival
Secondary outcome: Disease stabilisationDisease complications Side effects of therapy
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Haukeland University Hospital, University of Bergen, Bergen N-5021, Norway
Additional Information
Starting date: November 2004
Last updated: June 23, 2015
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