Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
61 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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:
- 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
First Consolidation Therapy:
- Cytarabine 1000 mg/m² bid i.v. days 1-3
- Mitoxantrone 10 mg/m² i.v. days 2, 3
- ATRA 15 mg/m² p.o. days 4-28
Second Consolidation Therapy
- Etoposide 100 mg/m² i.v. days 1-5
- Idarubicin 12 mg/m² i.v. days 1,3
- ATRA 15 mg/m² p.o. days 4-28
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
event-free survival
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
Richard F Schlenk, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Internal Medicine III, University of Ulm
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AMLSG06-04
NCT ID:
NCT00151255
Start Date:
June 2004
Completion Date:
January 2011
Related Keywords:
- Acute Myeloid Leukemia
- age > 60 years
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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