All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT00151255
- Lead Sponsor
- University of Ulm
- 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:
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method event-free survival two years
- Secondary Outcome Measures
Name Time Method overall survival two years kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs during therapy cumulative incidence of relapse two years complete remission (CR) rate after induction therapy after second induction cycle cumulative incidence of death two years
Trial Locations
- Locations (29)
Department of Hematology/Oncology, University Hospital of Innsbruck
🇦🇹Innsbruck, Austria
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
🇦🇹Linz, Austria
Medical Department III, St. Johann Hospital
🇦🇹Salzburg, Austria
Center of hematology and oncology, Hanusch Hospital
🇦🇹Wien, Austria
Department of Internal Medicine I, Central Hospital of Augsburg
🇩🇪Augsburg, Germany
Department of General Internal Medicine, University Hospital of Bonn
🇩🇪Bonn, Germany
Medical Department I, Hospital of Bremen-Mitte
🇩🇪Bremen, Germany
Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden
🇩🇪Essen, Germany
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
🇩🇪Frankfurt, Germany
Medical Department IV, University Hospital of Giessen
🇩🇪Giessen, Germany
Scroll for more (19 remaining)Department of Hematology/Oncology, University Hospital of Innsbruck🇦🇹Innsbruck, Austria