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

Sponsored by:	University of Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00151255

Purpose

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).

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Cytarabine Drug: Idarubicin Drug: All-trans retinoic acid Drug: Mitoxantrone Drug: Etoposid	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Mitoxantrone hydrochloride Mitoxantrone Tretinoin

U.S. FDA Resources

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

Further study details as provided by University of Ulm:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	500
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)

12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)

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)

10mg/m² i.v. day 2-3 (first consolidation cycle)

100mg/m² i.v. Tag 1-5 (second consolidation cycle)

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

Eligibility

Ages Eligible for Study:	61 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151255

Locations

Austria
Department of Hematology/Oncology, University Hospital of Innsbruck
Innsbruck, Austria, 6020
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
Linz, Austria, 4010
Medical Department III, St. Johann Hospital
Salzburg, Austria, 5020
Center of hematology and oncology, Hanusch Hospital
Wien, Austria, 1140
Germany
Department of General Internal Medicine, University Hospital of Bonn
Bonn, Germany, 53127
Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden
Essen, Germany, 45239
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
Frankfurt, Germany, 65929
Medical Department IV, University Hospital of Giessen
Giessen, Germany, 35392
Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH
Goch, Germany, 47574
Centre of Internal Medicine, University Hospital of Göttingen
Göttingen, Germany, 37075
Department of Oncology and Hematology, University Hospital Eppendorf
Hamburg, Germany, 20246
Department of Internal Medicine I, University Hospital of Saarland
Homburg, Germany, 66421
Medical Department II, City Hospital Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Medical Department II, University Hospital of Kiel
Kiel, Germany, 24116
Medical Department II, Diakonie Hospital
Stuttgart, Germany, 70176
Department of Hematology/Oncology, Clinical Center of Lüdenscheid
Lüdenscheid, Germany, 58515
Medical Department III, Clinical Center Rechts der Isar
München, Germany, 81675
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
Oldenburg, Germany, 26133
Department of Hematology and Oncology/Caritas Hospital St. Theresa
Saarbrücken, Germany, 66113
Department of Oncology, Clinical Center of Stuttgart
Stuttgart, Germany, 70174
I. Medical Department, Hospital of Barmerzigen Brüder
Trier, Germany, 54292
Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen
Villingen - Schwenningen, Germany, 78050
Medical Department I, Helios Hospital Wuppertal
Wuppertal, Germany, 42283
Department of Internal Medicine I, Central Hospital of Augsburg
Augsburg, Germany, 86856
Medical Department I, Hospital of Bremen-Mitte
Bremen, Germany, 28177
Medical Department II, General Hospital Altona
Hamburg, Germany, 22763
Medical Department III, Hospital of Hanau
Hanau, Germany, 63450
Medical Department III, Hospital of Hannover-Siloah
Hannover, Germany, 30449
Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach
Lebach, Germany, 66822

Sponsors and Collaborators

University of Ulm

Investigators

Principal Investigator:

Richard F Schlenk, Dr.

Department of Internal Medicine III, University of Ulm

More Information

study office of the Department of Internal Medicine III, University of Ulm This link exits the ClinicalTrials.gov site

Responsible Party:	University of Ulm ( Prof. Dr. Reinhard Marre )
Study ID Numbers:	AMLSG06-04
Study First Received:	September 6, 2005
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00151255
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:

age > 60 years

Study placed in the following topic categories:

Leukemia
Idarubicin
Acute myelogenous leukemia
Tretinoin
Mitoxantrone

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Keratolytic Agents
Neoplasms
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009