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

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

October 1, 2008

Start Date ^ICMJE

June 2004

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

event-free survival

Change History

Complete list of historical versions of study NCT00151255 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs [ Time Frame: during therapy ] [ Designated as safety issue: Yes ]
complete remission (CR) rate after induction therapy [ Time Frame: after second induction cycle ] [ Designated as safety issue: No ]
cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]
cumulative incidence of death [ Time Frame: two years ] [ Designated as safety issue: No ]
overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs
CR-rate after induction therapy
cumulative incidence of relapse
cumulative incidence of death
overall survival

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Drug: Cytarabine
Drug: Idarubicin
Drug: All-trans retinoic acid
Drug: Mitoxantrone
Drug: Etoposid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

61 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT ID ^ICMJE

NCT00151255

Responsible Party

Prof. Dr. Reinhard Marre, University of Ulm

Study ID Numbers ^ICMJE

AMLSG06-04

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard F Schlenk, Dr.

Department of Internal Medicine III, University of Ulm

Information Provided By

University of Ulm

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP