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Drug Information from MedlinePlus
Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase III, Phase II
Treatment
Active
18 to 60
Other
AMLSG07-04
NCT00151242

Trial Description

Summary

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

Further Study Information

First Induction Therapy:

  • 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

Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia [APL])
  • 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:

  • Bleeding independent of the AML
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Richard F Schlenk, Dr.Principal Investigator

Richard F Schlenk, Dr.Ph: 0049-(0)731-500- Ext.45900
  Email: richard.schlenk@uniklinik-ulm.de

Trial Sites

Austria
  Innsbruck
 David Nachbaur, Prof. Dr.Principal Investigator
 Innsbruck Universitaetsklinik
 David Nachbaur, Prof. Dr. Ph: 0043-650-8709121 Ext.23338
  Linz
 Andreas Petzer, Prof. Dr.Principal Investigator
 A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung
 Andreas Petzer, Prof. Dr. Ph: +43- 732 -7677 - Ext.7345
  Email: andreas.petzer@bhs.at
  Salzburg
 Richard GreilPrincipal Investigator
 Medical Department III, St. Johann-Hospital
 R. Greil, Prof. Dr. Ph: +43-662-4482- Ext.2879
  Email: R.Greil@salk.at
  Wien
 Elisabeth Pittermann-Höcker, Prim. Dr.Principal Investigator
 Hanusch-Krankenhaus
 Elisabeth Pittermann-Höcker, Prim. Dr. Ph: +43 01-91021- Ext.85411
  Email: elisabeth.pittermann-hoecker@wgkk.sozvers.at
Germany
  Bonn
 Ingo Schmidt-Wolf, Prof. Dr.Principal Investigator
 Universitaetsklinikum Bonn
 Ingo Schmidt-Wolf, Prof. Dr. Ph: 0049-(0)228-287 Ext.6816
  Email: Ingo.schmidt-wolf@ukb.uni-bonn.dede
  Bremen
 Medical Department I, Hospital Bremen-Mitte
 Bernd Hertenstein, Prof. Dr. Ph: 0049-(0)421-497- Ext.5240
  Email: bernd.hertenstein@klinikum-bremen-mitte.de
 Bernd HertensteinPrincipal Investigator
  Düsseldorf
 Ulrich Germing, PD Dr.Principal Investigator
 Universitaetsklinikum Duesseldorf
 Ulrich Germing, PD Dr. Ph: +49 (0) 211-811-7780 Ext.8853
  Email: germing@med.uni-duesseldorf.de
  Essen
 Wolfgang HeitPrincipal Investigator
 Evangelisches Krankenhaus Essen Werden
 Wolfgang Heit, Prof. Dr. Ph: +49 (0) 201-4089-2231 Ext.2297
  Email: w.heit.medk@kliniken-essen-sued.de
  Frankfurt
 Hans-Günther Derigs, Prof. Dr.Principal Investigator
 Staedtische Kliniken Frankfurt am Main - Hoechst
 Hans-Günther Derigs, Prof. Dr. Ph: +49 (0) 69-3106-3320 Ext.3280
  Email: derigs@skfh.de
 Dieter Hölzer, Prof. Dr.Principal Investigator
 Universitaetsfrauenklinik Frankfurt
 Dieter Hölzer, Prof. Dr. Ph: +49 (0) 69-6301-5194 Ext.7326
  Email: hoelzer@em.uni-frankfurt.de
  Freiburg
 Michael Lübbert, Prof. Dr.Principal Investigator
 Universitaetskinderklinik - Universitaetsklinikum Freiburg
 Michael Lübbert, Prof. Dr. Ph: +49 (0) 761-270-3401 Ext.3697
  Email: luebbert@mm11.ukl.uni-freiburg.de
  Giessen
 Mathias Rummel, PD Dr.Principal Investigator
 Universitaetsklinikum Giessen und Marburg GmbH - Giessen
 Mathias Rummel, PD Dr.
  Email: mathias.rummel@innere.med.uni-giessen.de
  Goch
 Volker Runde, Prof. Dr.Principal Investigator
 Wilhelm-Anton-Hospital gGmbH, Goch
 Volker Runde, Prof. Dr. Ph: +49 (0) 2823-891-115 Ext.322
  Email: innere@wilhelm-anton-hospital-goch.de
  Göttingen
 Lorenz Trümper, Prof. Dr.Principal Investigator
 Universitaetsklinikum Goettingen
 Lorenz Trümper, Prof. Dr. Ph: +49 (0) 551-39-8535 Ext.8587
  Email: lorenz.truemper@med.uni-goettingen.de
  Hamburg
 Hans Salwender, Dr.Principal Investigator
 Allgemeines Krankenhaus Altona
 Hans Salwender, Dr. Ph: +49 (0) 40-8822-1212 Ext.4904
  Email: salwender@web.de
 Carsten Bokemeyer, Prof. Dr.Principal Investigator
 University Medical Center Hamburg - Eppendorf
 Carsten Bokemeyer, Prof. Dr. Ph: +49 (0) 40 / 42803 - 2960 Ext.8054
  Email: c.bokemeyer@uke.uni-hamburg.de
  Hanau
 Andrea Sendler, Dr.Principal Investigator
 Haematologie Und Internistische Onkologie
 Andrea Sendler, Dr. Ph: +49 (0) 6181-296-4345 Ext.4309
  Email: andrea_sendler@klinikum-hanau.de
  Hannover
 Krankenhaus Siloah - Medizinische Klinik II
 Hartmut Kirchner, PD Dr. Ph: 0049-(0)511-927- Ext.2801
  Email: Hartmut.Kirchner.Siloah@krh.eu
 Hartmut Kirchner, PD Dr.Principal Investigator
 Arnold Ganser, Prof. Dr.Principal Investigator
 Medizinische Hochschule Hannover
 Arnold Ganser, Prof. Dr. Ph: +49 (0) 511-532-5112 Ext.8041
  Email: ganser.arnold@mh-hannover.de
  Homburg
 Michael Pfreundschuh, Prof. Dr.Principal Investigator
 Universitaetsklinikum des Saarlandes
 Michael Pfreundschuh, Prof. Dr. Ph: +49 (0) 6841-162-3084 Ext.3031
  Email: michael.pfreundschuh@uniklinik-saarland.de
  Karlsruhe
 Martin Bentz, Prof. Dr.Principal Investigator
 Staedtisches Klinikum Karlsruhe gGmbH
 Martin Bentz, Prof. Dr. Ph: +49 (0) 721-974-3000 Ext.3009
  Email: Martin.Bentz@klinikum-karlsruhe.com
  Kiel
 H.-A. Horst, PD Dr.Principal Investigator
 University Hospital Schleswig-Holstein - Kiel Campus
 H.-A. Horst, PD Dr. Ph: +49 (0) 431-1697-1207 Ext.1202
  Email: h.horst@med2.uni-kiel.de
  Lebach
 Stephan Kremers, Dr.Principal Investigator
 Caritas - Krakenhaus Lebach
 Stephan Kremers, Dr. Ph: +49 (0) 6881-501-217 Ext.153
  Email: s.kremers@caritas-krankenhaus-lebach.de
  Lüdenscheid
 Kreiskrankenhaus Luedenscheid
 Gerhard Heil, Prof. Dr. Ph: 0049-(0)2351-46 Ext.3541
  Email: gerhard.heil@klinikum-luedenscheid.de
 Gerhard Heil, Prof. Dr.Principal Investigator
  Mainz
 Matthias Theobald, Prof. Dr.Principal Investigator
 Johannes Gutenberg University
 Matthias Theobald, Prof. Dr. Ph: +49 (0) 6131-175047 Ext.3933364
  Email: m.theobald@3-med.klinik.uni-mainz.de
  München
 Christian Peschel, Prof. Dr.Principal Investigator
 Klinikum Rechts Der Isar - Technische Universitaet Muenchen
 Christian Peschel, Prof. Dr. Ph: +49 (0) 89-4140-4111 Ext.4809
  Email: christian.peschel@lrz.tum.de
  Oldenburg
 Francesco del Valle, Dr.Principal Investigator
 Klinikum Oldenburg
 Francesco del Valle, Dr. Ph: +49 (0) 441-403-2615 Ext.2892
  Email: delvalle.f@klinikum-oldenburg.de
  Saarbrücken
 Axel Matzdorff, PD Dr.Principal Investigator
 Caritasklinik St. Theresia
 Axel Matzdorff, PD Dr. Ph: +49 (0) 681-406-1104
  Email: a.matzdorff@caritasklinik.de
  Stuttgart
 Hans-Guenther MergenthalerPrincipal Investigator
 Klinik fuer Onkologie - Katharinenhospital Stuttgart
 Hans-Günther Mergenthaler, Prof. Dr. Ph: +49 (0) 711-278-5601 Ext.5609
  Email: h.mergenthaler@katharinenhospital.de
 Medical Department II, Diakonie Hospital
 Else Heidemann, Prof. Dr. Ph: 0049-(0)711-991-0
  Email: heidemann@diak-stuttgart.de
 Else Heidemann, Prof. Dr.Principal Investigator
  Trier
 Heinz Kirchen, Dr.Principal Investigator
 Medical Department I, Hospital of Barmherzige Brüder
 Heinz Kirchen, Dr. Ph: +49 (0) 651-2080 Ext.2678
  Email: h.kirchen@bk-trier.de
  Tübingen
 Peter Brossart, PD Dr.Principal Investigator
 Universitaetsklinikum Tuebingen
 Peter Brossart, PD Dr. Ph: 49+ (0)7071-29-80625 Ext.5709
  Email: peter.brossart@med.uni-tuebingen.de
  Villingen-Schwenningen
 Wolfram BruggerPrincipal Investigator
 Klinikum Der Stadt Villingen - Schwenningen
 Wolfram Brugger, Prof. Dr. Ph: +49 (0) 7721-93-4001 Ext.4099
  Email: imo.wolfram.brugger@klinikumvs.de
  Wuppertal
 Aruna Raghavachar, PD Dr.Principal Investigator
 Helios Kliniken Wuppertal University Hospital
 Aruna Raghavachar, PD Dr. Ph: +49 (0) 202-896-3351 Ext.2739
  Email: araghavachar@wuppertal.helios-kliniken.de

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00151242
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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