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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cytarabine
Idarubicin
All-trans retinoic acid
Mitoxantrone
Etoposid
Sponsored by
University of Ulm
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring age > 60 years

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology/Oncology, University Hospital of Innsbruck
  • Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
  • Medical Department III, St. Johann Hospital
  • Center of hematology and oncology, Hanusch Hospital
  • Department of Internal Medicine I, Central Hospital of Augsburg
  • Department of General Internal Medicine, University Hospital of Bonn
  • Medical Department I, Hospital of Bremen-Mitte
  • Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden
  • Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
  • Medical Department IV, University Hospital of Giessen
  • Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH
  • Centre of Internal Medicine, University Hospital of Göttingen
  • Department of Oncology and Hematology, University Hospital Eppendorf
  • Medical Department II, General Hospital Altona
  • Medical Department III, Hospital of Hanau
  • Medical Department III, Hospital of Hannover-Siloah
  • Department of Internal Medicine I, University Hospital of Saarland
  • Medical Department II, City Hospital Karlsruhe gGmbH
  • Medical Department II, University Hospital of Kiel
  • Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach
  • Department of Hematology/Oncology, Clinical Center of Lüdenscheid
  • Medical Department III, Clinical Center Rechts der Isar
  • Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
  • Department of Hematology and Oncology/Caritas Hospital St. Theresa
  • Department of Oncology, Clinical Center of Stuttgart
  • Medical Department II, Diakonie Hospital
  • I. Medical Department, Hospital of Barmerzigen Brüder
  • Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen
  • Medical Department I, Helios Hospital Wuppertal

Outcomes

Primary Outcome Measures

event-free survival

Secondary Outcome Measures

kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs
complete remission (CR) rate after induction therapy
cumulative incidence of relapse
cumulative incidence of death
overall survival

Full Information

First Posted
September 6, 2005
Last Updated
April 18, 2017
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT00151255
Brief Title
All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
age > 60 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Description
12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
Intervention Type
Drug
Intervention Name(s)
All-trans retinoic acid
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
10mg/m² i.v. day 2-3 (first consolidation cycle)
Intervention Type
Drug
Intervention Name(s)
Etoposid
Intervention Description
100mg/m² i.v. Tag 1-5 (second consolidation cycle)
Primary Outcome Measure Information:
Title
event-free survival
Time Frame
two years
Secondary Outcome Measure Information:
Title
kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs
Time Frame
during therapy
Title
complete remission (CR) rate after induction therapy
Time Frame
after second induction cycle
Title
cumulative incidence of relapse
Time Frame
two years
Title
cumulative incidence of death
Time Frame
two years
Title
overall survival
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F Schlenk, Dr.
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology/Oncology, University Hospital of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medical Department III, St. Johann Hospital
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Center of hematology and oncology, Hanusch Hospital
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Department of Internal Medicine I, Central Hospital of Augsburg
City
Augsburg
ZIP/Postal Code
86856
Country
Germany
Facility Name
Department of General Internal Medicine, University Hospital of Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Medical Department I, Hospital of Bremen-Mitte
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Medical Department IV, University Hospital of Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH
City
Goch
ZIP/Postal Code
47574
Country
Germany
Facility Name
Centre of Internal Medicine, University Hospital of Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Department of Oncology and Hematology, University Hospital Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medical Department II, General Hospital Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medical Department III, Hospital of Hanau
City
Hanau
ZIP/Postal Code
63450
Country
Germany
Facility Name
Medical Department III, Hospital of Hannover-Siloah
City
Hannover
ZIP/Postal Code
30449
Country
Germany
Facility Name
Department of Internal Medicine I, University Hospital of Saarland
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Medical Department II, City Hospital Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Medical Department II, University Hospital of Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Department of Hematology/Oncology, Clinical Center of Lüdenscheid
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Medical Department III, Clinical Center Rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Department of Hematology and Oncology/Caritas Hospital St. Theresa
City
Saarbrücken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Department of Oncology, Clinical Center of Stuttgart
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Medical Department II, Diakonie Hospital
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Facility Name
I. Medical Department, Hospital of Barmerzigen Brüder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen
City
Villingen - Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Medical Department I, Helios Hospital Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24797300
Citation
Tassara M, Dohner K, Brossart P, Held G, Gotze K, Horst HA, Ringhoffer M, Kohne CH, Kremers S, Raghavachar A, Wulf G, Kirchen H, Nachbaur D, Derigs HG, Wattad M, Koller E, Brugger W, Matzdorff A, Greil R, Heil G, Paschka P, Gaidzik VI, Gottlicher M, Dohner H, Schlenk RF. Valproic acid in combination with all-trans retinoic acid and intensive therapy for acute myeloid leukemia in older patients. Blood. 2014 Jun 26;123(26):4027-36. doi: 10.1182/blood-2013-12-546283. Epub 2014 May 5. Erratum In: Blood. 2015 May 7;125(19):3037.
Results Reference
derived
PubMed Identifier
23863898
Citation
Schlenk RF, Taskesen E, van Norden Y, Krauter J, Ganser A, Bullinger L, Gaidzik VI, Paschka P, Corbacioglu A, Gohring G, Kundgen A, Held G, Gotze K, Vellenga E, Kuball J, Schanz U, Passweg J, Pabst T, Maertens J, Ossenkoppele GJ, Delwel R, Dohner H, Cornelissen JJ, Dohner K, Lowenberg B. The value of allogeneic and autologous hematopoietic stem cell transplantation in prognostically favorable acute myeloid leukemia with double mutant CEBPA. Blood. 2013 Aug 29;122(9):1576-82. doi: 10.1182/blood-2013-05-503847. Epub 2013 Jul 17.
Results Reference
derived

Learn more about this trial

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

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