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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT00151255
First received: September 6, 2005
Last updated: October 12, 2011
Last verified: October 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • event-free survival [ Time Frame: one year ] [ 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
Study Completion Date: January 2011
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
    Drug: Idarubicin
    12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
    Drug: 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)
    Drug: Mitoxantrone
    10mg/m² i.v. day 2-3 (first consolidation cycle)
    Drug: Etoposid
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Internal Medicine I, Central Hospital of Augsburg
Augsburg, Germany, 86856
Department of General Internal Medicine, University Hospital of Bonn
Bonn, Germany, 53127
Medical Department I, Hospital of Bremen-Mitte
Bremen, Germany, 28177
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
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 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
Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach
Lebach, Germany, 66822
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
Medical Department II, Diakonie Hospital
Stuttgart, Germany, 70176
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
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Richard F Schlenk, Dr. Department of Internal Medicine III, University of Ulm
  More Information

Additional Information:
No publications provided by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Richard Schlenk, PD Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT00151255     History of Changes
Other Study ID Numbers: AMLSG06-04
Study First Received: September 6, 2005
Last Updated: October 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
age > 60 years

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Mitoxantrone
Tretinoin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014