Status:
COMPLETED
All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
University of Ulm
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
61+ years
Phase:
PHASE3
Brief Summary
This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).
Detailed Description
First Induction Therapy: * Cytarabine 100 mg/m² cont. i.v. days 1-5 * Idarubicin 12 mg/m² i.v. days 1, 3 * ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28 Second Induction Therapy: * C...
Eligibility Criteria
Inclusion
- Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia \[APL\])
- Aged \> 60 years
- All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
- Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.
Exclusion
- Bleeding independent of the AML
- Acute promyelocytic leukemia
- Uncontrolled infection
- Participation in a concurrent clinical study
- Insufficiency of the kidneys (creatinine \> 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP \> 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association \[NYHA\] III/IV
- Severe neurological or psychiatric disorder interfering with ability of giving informed consent
- No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
- Performance status WHO \> 2
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00151255
Start Date
June 1 2004
End Date
January 1 2011
Last Update
April 19 2017
Active Locations (29)
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1
Department of Hematology/Oncology, University Hospital of Innsbruck
Innsbruck, Austria, 6020
2
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
Linz, Austria, 4010
3
Medical Department III, St. Johann Hospital
Salzburg, Austria, 5020
4
Center of hematology and oncology, Hanusch Hospital
Vienna, Austria, 1140