|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Bergen |
|---|---|
| Information provided by: | University of Bergen |
| ClinicalTrials.gov Identifier: | NCT00175812 |
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)+valproic acid+theophyllamin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Differentiation Induction Therapy for Acute Myelogenous Leukemia |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2004 |
| Estimated Study Completion Date: | November 2009 |
Patients to be included:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| Haukeland University Hospital, University of Bergen | Recruiting |
| Bergen, Norway, N-5021 | |
| Contact: Oystein Bruserud, MD +47 55 97 50 00 oystein.bruserud@haukeland.no | |
| Contact: Peter Ernst, MD +47 55 97 50 00 peter.ernst@med.uib.no | |
| Principal Investigator: Oystein Bruserud, MD | |
| Principal Investigator: | Oystein Bruserud, MD | University of Bergen |
More Information
| Study ID Numbers: | REK-Vestnr21503 |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00175812 |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
Acute myelogenous leukemia Differentiation All trans retinoic acid Valproic acid Theophyllamin |
|
Leukemia Acute myelogenous leukemia Tretinoin Leukemia, Myeloid |
Leukemia, Myeloid, Acute Valproic Acid Acute myelocytic leukemia |
|
Neurotransmitter Agents Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Keratolytic Agents Neoplasms Therapeutic Uses GABA Agents Dermatologic Agents Central Nervous System Agents Anticonvulsants |
