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

Phase 3

Completed

• 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

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2009-06
• Study Completion: 2011-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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 Internal Medicine I, Krankenhaus der Barmherzigen Schwestern; 🇦🇹 Linz, Austria

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 III, Hospital of Hanau; 🇩🇪 Hanau, Germany

Department of Internal Medicine I, University Hospital of Saarland; 🇩🇪 Homburg, Germany

Medical Department IV, University Hospital of Giessen; 🇩🇪 Giessen, Germany

Centre of Internal Medicine, University Hospital of Göttingen; 🇩🇪 Göttingen, Germany

Medical Department III, St. Johann Hospital; 🇦🇹 Salzburg, Austria

Department of Hematology/Oncology, University Hospital of Innsbruck; 🇦🇹 Innsbruck, Austria

Department of General Internal Medicine, University Hospital of Bonn; 🇩🇪 Bonn, Germany

Center of hematology and oncology, Hanusch Hospital; 🇦🇹 Wien, Austria

Department of Internal Medicine I, Central Hospital of Augsburg; 🇩🇪 Augsburg, Germany

Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH; 🇩🇪 Goch, Germany

Medical Department II, University Hospital of Kiel; 🇩🇪 Kiel, Germany

Medical Department III, Clinical Center Rechts der Isar; 🇩🇪 München, Germany

I. Medical Department, Hospital of Barmerzigen Brüder; 🇩🇪 Trier, Germany

Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen; 🇩🇪 Villingen - Schwenningen, Germany

Medical Department II, General Hospital Altona; 🇩🇪 Hamburg, Germany

Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach; 🇩🇪 Lebach, Germany

Medical Department II, Diakonie Hospital; 🇩🇪 Stuttgart, Germany

Department of Oncology and Hematology, University Hospital Eppendorf; 🇩🇪 Hamburg, Germany

Medical Department III, Hospital of Hannover-Siloah; 🇩🇪 Hannover, Germany

Department of Hematology and Oncology/Caritas Hospital St. Theresa; 🇩🇪 Saarbrücken, Germany

Medical Department I, Helios Hospital Wuppertal; 🇩🇪 Wuppertal, Germany

Medical Department II, City Hospital Karlsruhe gGmbH; 🇩🇪 Karlsruhe, Germany

Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany

Department of Hematology/Oncology, Clinical Center of Lüdenscheid; 🇩🇪 Lüdenscheid, Germany

Department of Oncology, Clinical Center of Stuttgart; 🇩🇪 Stuttgart, Germany