Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
NCT ID: NCT00995332
Last Updated: 2015-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2009-09-30
2013-06-30
Brief Summary
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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.
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Detailed Description
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1. Elderly patients (\>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (AML).
2. 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ATRA+valproc acid+low-dose cytarabine
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with relapsed or refractory AML
Exclusion Criteria
* Intolerance to study drugs
* Serious liver disease
18 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Responsible Party
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Øystein Bruserud
Professor
Principal Investigators
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Oystein Bruserud, MD
Role: STUDY_CHAIR
University of Bergen, Norway
Locations
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Haukeland University Hospital and University of Bergen
Bergen, , Norway
Countries
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References
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Fredly H, Ersvaer E, Kittang AO, Tsykunova G, Gjertsen BT, Bruserud O. The combination of valproic acid, all-trans retinoic acid and low-dose cytarabine as disease-stabilizing treatment in acute myeloid leukemia. Clin Epigenetics. 2013 Aug 1;5(1):13. doi: 10.1186/1868-7083-5-13.
Haaland I, Hjelle SM, Reikvam H, Sulen A, Ryningen A, McCormack E, Bruserud O, Gjertsen BT. p53 Protein Isoform Profiles in AML: Correlation with Distinct Differentiation Stages and Response to Epigenetic Differentiation Therapy. Cells. 2021 Apr 7;10(4):833. doi: 10.3390/cells10040833.
Reikvam H, Hovland R, Forthun RB, Erdal S, Gjertsen BT, Fredly H, Bruserud O. Disease-stabilizing treatment based on all-trans retinoic acid and valproic acid in acute myeloid leukemia - identification of responders by gene expression profiling of pretreatment leukemic cells. BMC Cancer. 2017 Sep 6;17(1):630. doi: 10.1186/s12885-017-3620-y.
Other Identifiers
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Rek VEST 231-06
Identifier Type: -
Identifier Source: org_study_id
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