All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Cytarabine (Drug); Idarubicin (Drug); All-trans retinoic acid (Drug); Mitoxantrone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Richard F Schlenk, Dr., Principal Investigator, Affiliation: Department of Internal Medicine III, University of Ulm

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).

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: event-free survival

Secondary outcome:

kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs

complete remission (CR) rate after induction therapy

cumulative incidence of relapse

cumulative incidence of death

overall survival

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

Minimum age: 61 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Department of Hematology/Oncology, University Hospital of Innsbruck, Innsbruck 6020, Austria

Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern, Linz 4010, Austria

Medical Department III, St. Johann Hospital, Salzburg 5020, Austria

Center of hematology and oncology, Hanusch Hospital, Wien 1140, Austria

Department of General Internal Medicine, University Hospital of Bonn, Bonn 53127, Germany

Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden, Essen 45239, Germany

Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst, Frankfurt 65929, Germany

Medical Department IV, University Hospital of Giessen, Giessen 35392, Germany

Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH, Goch 47574, Germany

Centre of Internal Medicine, University Hospital of Göttingen, Göttingen 37075, Germany

Department of Oncology and Hematology, University Hospital Eppendorf, Hamburg 20246, Germany

Department of Internal Medicine I, University Hospital of Saarland, Homburg 66421, Germany

Medical Department II, City Hospital Karlsruhe gGmbH, Karlsruhe 76133, Germany

Medical Department II, University Hospital of Kiel, Kiel 24116, Germany

Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach, Lebach 66822, Germany

Department of Hematology/Oncology, Clinical Center of Lüdenscheid, Lüdenscheid 58515, Germany

Medical Department III, Clinical Center Rechts der Isar, München 81675, Germany

Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH, Oldenburg 26133, Germany

Department of Hematology and Oncology/Caritas Hospital St. Theresa, Saarbrücken 66113, Germany

Department of Oncology, Clinical Center of Stuttgart, Stuttgart 70174, Germany

I. Medical Department, Hospital of Barmerzigen Brüder, Trier 54292, Germany

Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen, Villingen - Schwenningen 78050, Germany

Medical Department I, Helios Hospital Wuppertal, Wuppertal 42283, Germany

Department of Internal Medicine I, Central Hospital of Augsburg, Augsburg 86856, Germany

Medical Department I, Hospital of Bremen-Mitte, Bremen 28177, Germany

Medical Department II, General Hospital Altona, Hamburg 22763, Germany

Medical Department III, Hospital of Hanau, Hanau 63450, Germany

Medical Department III, Hospital of Hannover-Siloah, Hannover 30449, Germany

Medical Department II, Diakonie Hospital, Stuttgart 70176, Germany

study office of the Department of Internal Medicine III, University of Ulm

Starting date: June 2004
Ending date: October 2010
Last updated: June 18, 2008