Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00151242
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
920 participants
INTERVENTIONAL
2004-07-31
2013-08-31
Brief Summary
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Detailed Description
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* Cytarabine 100 mg/m² cont. i.v. days 1-7
* Idarubicin 12 mg/m² i.v. days 1,3,5
* Etoposide 100 mg/m² i.v. days 1-3
* ± ATRA 45 mg/m² p.o. days 6-8
* ATRA 15 mg/m² p.o. days 9-21
Second Induction Therapy:
* Cytarabine 100 mg/m² cont. i.v. days 1-7
* Idarubicin 12 mg/m² i.v. days 1 and 3
* Etoposide 100 mg/m² i.v. days 1-3
* ± ATRA 45 mg/m² p.o. days 6-8
* ATRA 15 mg/m² p.o. days 9-21
Consolidation Therapy:
cohort 1 (\<= ID 336)
* Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
* ± ATRA 15 mg/m² p.o. Tag 6-21
* Pegfilgrastim 6 mg s.c day 10
cohort 2 (\> ID 336)
* Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
* ± ATRA 15 mg/m² p.o. Tag 4-21
* Pegfilgrastim 6 mg s.c day 8
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
2
Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
All-trans retinoic acid
45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Interventions
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Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
All-trans retinoic acid
45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 18-60 years
* Written informed consent of each patient at study entry.
* Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories
Exclusion Criteria
* Acute promyelocytic leukemia
* Uncontrollable infection
* Participation in a concurrent clinical study
* Insufficiency of the kidneys (creatinine \> 1.5x upper normal serum level), of the liver (bilirubin, AST or AP \> 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
* Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
* No consent for registration, storage and processing of the individual disease-characteristics and course.
* Performance status WHO \> 2
* Pregnancy
18 Years
60 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Prof. Dr. Richard Schlenk
PD Dr.
Principal Investigators
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Richard F Schlenk, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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Department of Hematology/Oncology, University Hospital Innsbruck
Innsbruck, , Austria
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
Linz, , Austria
Medical Department III, St. Johann-Hospital
Salzburg, , Austria
Center of Hematology and Oncology, Hanusch-Hospital
Vienna, , Austria
Department of General Internal Medicine, University Hospital of Bonn
Bonn, , Germany
Medical Department I, Hospital Bremen-Mitte
Bremen, , Germany
Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf
Düsseldorf, , Germany
Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden
Essen, , Germany
Medical Department III, Hematology/Oncology, University of Frankfurt
Frankfurt, , Germany
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
Frankfurt, , Germany
Internal Medicine I, University of Freiburg
Freiburg im Breisgau, , Germany
Medical Department IV, University Hospital of Giessen
Giessen, , Germany
Department of Internal Medicine, Wilhelm-Anton-Hospital gGmbH
Goch, , Germany
Centre of Internal Medicine, University Hospital Göttingen
Göttingen, , Germany
Department of Oncology and Hematology, University Hospital Eppendorf
Hamburg, , Germany
Medical Department II, Hematology and Oncology, General Hospital Altona
Hamburg, , Germany
Medical Department III, Clinical Center Hanau
Hanau, , Germany
Medical Department III, Hospital Hannover-Siloah
Hanover, , Germany
Department of Hematology, Hematology and Oncology, Medizinische Hochschule Hannover
Hanover, , Germany
Department of Internal Medicine I, University Hospital of Saarland
Homburg, , Germany
Medical Department II, City Hospital Karlsruhe gGmbH
Karlsruhe, , Germany
Medical Department II, University Hospital of Kiel
Kiel, , Germany
Department of Internal Medicine/Hematology and Oncology, Cartias Hospital Lebach
Lebach, , Germany
Department of Hematology and Oncology, Hospital of Lüdenscheid
Lüdenscheid, , Germany
Department of Hematology and Internal Oncology, University Hospital of Mainz
Mainz, , Germany
Medical Department III, Clinical Center Rechts der Isar
München, , Germany
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
Oldenburg, , Germany
Department of Hematology and Oncology, Caritas Hospital St. Theresia
Saarbrücken, , Germany
Department of Oncology, Clinical Center of Stuttgart
Stuttgart, , Germany
Medical Department II, Diakonie Hospital
Stuttgart, , Germany
Medical Department I, Hospital of Barmherzige Brüder
Trier, , Germany
Department of Internal Medicine II, University Hospital of Tübingen
Tübingen, , Germany
Medical Clinic II-Hematology/Oncology, Hospital Villingen-Schwenningen
Villingen-Schwenningen, , Germany
Medical Department I, Helios Hospital Wuppertal
Wuppertal, , Germany
Countries
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References
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Schlenk RF, Lubbert M, Benner A, Lamparter A, Krauter J, Herr W, Martin H, Salih HR, Kundgen A, Horst HA, Brossart P, Gotze K, Nachbaur D, Wattad M, Kohne CH, Fiedler W, Bentz M, Wulf G, Held G, Hertenstein B, Salwender H, Gaidzik VI, Schlegelberger B, Weber D, Dohner K, Ganser A, Dohner H; German-Austrian Acute Myeloid Leukemia Study Group. All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study. Ann Hematol. 2016 Dec;95(12):1931-1942. doi: 10.1007/s00277-016-2810-z. Epub 2016 Oct 3.
Schlenk RF, Kayser S, Bullinger L, Kobbe G, Casper J, Ringhoffer M, Held G, Brossart P, Lubbert M, Salih HR, Kindler T, Horst HA, Wulf G, Nachbaur D, Gotze K, Lamparter A, Paschka P, Gaidzik VI, Teleanu V, Spath D, Benner A, Krauter J, Ganser A, Dohner H, Dohner K; German-Austrian AML Study Group. Differential impact of allelic ratio and insertion site in FLT3-ITD-positive AML with respect to allogeneic transplantation. Blood. 2014 Nov 27;124(23):3441-9. doi: 10.1182/blood-2014-05-578070. Epub 2014 Sep 30.
Gaidzik VI, Bullinger L, Schlenk RF, Zimmermann AS, Rock J, Paschka P, Corbacioglu A, Krauter J, Schlegelberger B, Ganser A, Spath D, Kundgen A, Schmidt-Wolf IG, Gotze K, Nachbaur D, Pfreundschuh M, Horst HA, Dohner H, Dohner K. RUNX1 mutations in acute myeloid leukemia: results from a comprehensive genetic and clinical analysis from the AML study group. J Clin Oncol. 2011 Apr 1;29(10):1364-72. doi: 10.1200/JCO.2010.30.7926. Epub 2011 Feb 22.
Kayser S, Schlenk RF, Londono MC, Breitenbuecher F, Wittke K, Du J, Groner S, Spath D, Krauter J, Ganser A, Dohner H, Fischer T, Dohner K; German-Austrian AML Study Group (AMLSG). Insertion of FLT3 internal tandem duplication in the tyrosine kinase domain-1 is associated with resistance to chemotherapy and inferior outcome. Blood. 2009 Sep 17;114(12):2386-92. doi: 10.1182/blood-2009-03-209999. Epub 2009 Jul 14.
Schlenk RF, Dohner K, Kneba M, Gotze K, Hartmann F, Del Valle F, Kirchen H, Koller E, Fischer JT, Bullinger L, Habdank M, Spath D, Groner S, Krebs B, Kayser S, Corbacioglu A, Anhalt A, Benner A, Frohling S, Dohner H; German-Austrian AML Study Group (AMLSG). Gene mutations and response to treatment with all-trans retinoic acid in elderly patients with acute myeloid leukemia. Results from the AMLSG Trial AML HD98B. Haematologica. 2009 Jan;94(1):54-60. doi: 10.3324/haematol.13378. Epub 2008 Dec 4.
Other Identifiers
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AMLSG07-04
Identifier Type: -
Identifier Source: org_study_id