Differentiation Induction in Acute Myelogenous Leukemia
Recruitment status was Active, not recruiting
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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 |
- 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 ]
| 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) |
-
Drug: all-trans retinoic acid (ATRA)
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.
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:
- 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 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, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Valproic Acid Theophylline Tretinoin Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents |
Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Phosphodiesterase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013