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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151255
• Other study ID #: AMLSG06-04
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: April 18, 2017
• Start date: June 2004
• Est. completion date: January 2011

Study information

• Verified date: April 2017
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytarabine
100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
• Idarubicin
12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
• All-trans retinoic acid
45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
• Mitoxantrone
10mg/m² i.v. day 2-3 (first consolidation cycle)
• Etoposid
100mg/m² i.v. Tag 1-5 (second consolidation cycle)

Locations

Country	Name	City	State
Austria	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
Germany	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	Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH	Goch
Germany	Centre of Internal Medicine, University Hospital of Göttingen	Göttingen
Germany	Department of Oncology and Hematology, University Hospital Eppendorf	Hamburg
Germany	Medical Department II, General Hospital Altona	Hamburg
Germany	Medical Department III, Hospital of Hanau	Hanau
Germany	Medical Department III, Hospital of Hannover-Siloah	Hannover
Germany	Department of Internal Medicine I, University Hospital of Saarland	Homburg
Germany	Medical Department II, City Hospital Karlsruhe gGmbH	Karlsruhe
Germany	Medical Department II, University Hospital of Kiel	Kiel
Germany	Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach	Lebach
Germany	Department of Hematology/Oncology, Clinical Center of Lüdenscheid	Lüdenscheid
Germany	Medical Department III, Clinical Center Rechts der Isar	München
Germany	Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH	Oldenburg
Germany	Department of Hematology and Oncology/Caritas Hospital St. Theresa	Saarbrücken
Germany	Department of Oncology, Clinical Center of Stuttgart	Stuttgart
Germany	Medical Department II, Diakonie Hospital	Stuttgart
Germany	I. Medical Department, Hospital of Barmerzigen Brüder	Trier
Germany	Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen	Villingen - Schwenningen
Germany	Medical Department I, Helios Hospital Wuppertal	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival		two years
Secondary	kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs		during therapy
Secondary	complete remission (CR) rate after induction therapy		after second induction cycle
Secondary	cumulative incidence of relapse		two years
Secondary	cumulative incidence of death		two years
Secondary	overall survival		two years

External Links

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