All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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
1 other identifier
interventional
500
2 countries
29
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2004
Longer than P75 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedApril 19, 2017
April 1, 2017
5 years
September 6, 2005
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
event-free survival
two years
Secondary Outcomes (5)
kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs
during therapy
complete remission (CR) rate after induction therapy
after second induction cycle
cumulative incidence of relapse
two years
cumulative incidence of death
two years
overall survival
two years
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Department of Hematology/Oncology, University Hospital of Innsbruck
Innsbruck, 6020, Austria
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
Linz, 4010, Austria
Medical Department III, St. Johann Hospital
Salzburg, 5020, Austria
Center of hematology and oncology, Hanusch Hospital
Vienna, 1140, Austria
Department of Internal Medicine I, Central Hospital of Augsburg
Augsburg, 86856, Germany
Department of General Internal Medicine, University Hospital of Bonn
Bonn, 53127, Germany
Medical Department I, Hospital of Bremen-Mitte
Bremen, 28177, Germany
Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden
Essen, 45239, Germany
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
Frankfurt, 65929, Germany
Medical Department IV, University Hospital of Giessen
Giessen, 35392, Germany
Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH
Goch, 47574, Germany
Centre of Internal Medicine, University Hospital of Göttingen
Göttingen, 37075, Germany
Department of Oncology and Hematology, University Hospital Eppendorf
Hamburg, 20246, Germany
Medical Department II, General Hospital Altona
Hamburg, 22763, Germany
Medical Department III, Hospital of Hanau
Hanau, 63450, Germany
Medical Department III, Hospital of Hannover-Siloah
Hanover, 30449, Germany
Department of Internal Medicine I, University Hospital of Saarland
Homburg, 66421, Germany
Medical Department II, City Hospital Karlsruhe gGmbH
Karlsruhe, 76133, Germany
Medical Department II, University Hospital of Kiel
Kiel, 24116, Germany
Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach
Lebach, 66822, Germany
Department of Hematology/Oncology, Clinical Center of Lüdenscheid
Lüdenscheid, 58515, Germany
Medical Department III, Clinical Center Rechts der Isar
München, 81675, Germany
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
Oldenburg, 26133, Germany
Department of Hematology and Oncology/Caritas Hospital St. Theresa
Saarbrücken, 66113, Germany
Department of Oncology, Clinical Center of Stuttgart
Stuttgart, 70174, Germany
Medical Department II, Diakonie Hospital
Stuttgart, 70176, Germany
I. Medical Department, Hospital of Barmerzigen Brüder
Trier, 54292, Germany
Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen
Villingen-Schwenningen, 78050, Germany
Medical Department I, Helios Hospital Wuppertal
Wuppertal, 42283, Germany
Related Publications (2)
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.
PMID: 24797300DERIVEDSchlenk 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.
PMID: 23863898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard F Schlenk, Dr.
University of Ulm
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr.
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
June 1, 2004
Primary Completion
June 1, 2009
Study Completion
January 1, 2011
Last Updated
April 19, 2017
Record last verified: 2017-04