Status:
COMPLETED
Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
University of Ulm
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed a...
Detailed Description
First Induction Therapy: * Cytarabine 100 mg/m² cont. i.v. days 1-7 * Idarubicin 12 mg/m² i.v. days 1,3,5 * Etoposide 100 mg/m² i.v. days 1-3 * ± ATRA 45 mg/m² p.o. days 6-8 * ATRA 15 mg/m² p.o. days...
Eligibility Criteria
Inclusion
- Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia \[APL\])
- Ages 18-60 years
- Written informed consent of each patient at study entry.
- Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories
Exclusion
- Bleeding independent of the AML
- Acute promyelocytic leukemia
- Uncontrollable infection
- Participation in a concurrent clinical study
- Insufficiency of the kidneys (creatinine \> 1.5x upper normal serum level), of the liver (bilirubin, AST or AP \> 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
- No consent for registration, storage and processing of the individual disease-characteristics and course.
- Performance status WHO \> 2
- Pregnancy
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
920 Patients enrolled
Trial Details
Trial ID
NCT00151242
Start Date
July 1 2004
End Date
August 1 2013
Last Update
September 20 2017
Active Locations (34)
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1
Department of Hematology/Oncology, University Hospital 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