Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
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Purpose
Hypothesis: Combined treatment with valproic acid and ATRA can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (AML), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment.
Adult patients >18 years of age who can be included:
Elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant AML.
Treatment: Combined therapy with:
Valproic acid, continuous therapy until disease progression ATRA, oral therapy for 14 days every three months Low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia |
Drug: Cytarabine, all-trans retinoic acid, valproic acid |
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: | Treatment of Acute Myelogenous Leukemia With the Histone Deacetylase Inhibitor Valproic Cid in Combination With All-trans Retinoic Acid (ATRA) and Low Dose Cytarabine |
- Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Disease stabilization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Disease complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Side effects of therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ATRA+valproc acid+low-dose cytarabine |
Drug: Cytarabine, all-trans retinoic acid, valproic acid
ATRA: 22.5 mg/m2 twice daily for 2 weeks every third month Valproic acid: continuous therapy, dosage guided by serum levels Cytarabine: 10 mg/m2 once daily for up to 10 days every third month
Other Name: No other names
|
Detailed Description:
Patients to be included:
- Elderly patients (>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
- Adult patients of any age (>18 years of age) with relapsed or resistant AML who cannot receive conventional therapy.
Treatment:
Valproic acid to be started on day 1 as continuous therapy until disease progression.
ATRA administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month.
Low-dose cytarabine 10 mg/m2 from day 14 and continued as daily injections for up to 10 days, repeated every third month.
Supportive therapy is given according to the hospitals general guidelines.
Followup: The first 2 days treatment in hospital, later regular out-patient treatment. Controls will include clinical examination, peripheral blood parameters (including serum valproic acid levels), bone marrow samples.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recently diagnosed AML in patients unfit for intensive chemotherapy
- Patients with relapsed or refractory AML
Exclusion Criteria:
- No informed consent
- Intolerance to study drugs
- Serious liver disease
Contacts and Locations| Contact: Oystein Bruserud, MD | +47 55 97 29 97 | oystein.bruserud@haukeland.no |
| Norway | |
| Haukeland University Hospital and University of Bergen | Recruiting |
| Bergen, Norway, N-5021 | |
| Contact: Oystein Bruserud, MD +47 55 97 29 97 oystein.bruserud@haukeland.no | |
| Principal Investigator: Oystein Bruserud, MD | |
| Study Chair: | Oystein Bruserud, MD | University of Bergen, Norway |
More Information
No publications provided
| Responsible Party: | Professor Oystein Bruserud, University of Bergen and Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00995332 History of Changes |
| Other Study ID Numbers: | Rek VEST 231-06 |
| Study First Received: | October 14, 2009 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by University of Bergen:
|
Acute myelogenous leukemia all-trans retinoic acid valproic acid cytarabine |
Disease stabilization survival toxicity |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Valproic Acid Cytarabine Tretinoin Histone Deacetylase Inhibitors 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 Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Keratolytic Agents |
ClinicalTrials.gov processed this record on May 22, 2013