Protocol in Acute Myeloid Leukemia With FLT3-ITD
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Acute myeloid leukemia, FLT3-ITD, midostaurin (PKC412)
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Midostaurin Type: Drug
Name: Cytarabine Type: Drug
Name: Daunorubicin Type: Drug
Overall Status
Recruiting
Summary
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.

The primary efficacy object is to evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.

Sample size: 284 patients

The treatment duration of an individual patient is between 18 and 24 months. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance and follow-up period: 48 months
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with suspected diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)

- Presence of FLT3-ITD assessed in the central AMLSG reference laboratories

- Patients considered eligible for intensive chemotherapy

- WHO performance status of ≤ 2

- Age ≥ 18 years and ≤ 70 years

- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis (≤ 7 days)

- Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)

- Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 5 months after the last dose of chemotherapy

- Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control

- Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy (while on therapy and for 5 months after the last dose of chemotherapy)

- Signed written informed consent.

Exclusion Criteria:

•AML with the following recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)

- Performance status WHO >2

- Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1

- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)

- Uncontrolled infection

- Severe neurological or psychiatric disorder interfering with ability of giving an informed consent

- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year

- Known positive for HIV; active HBV, HCV, or Hepatitis A infection

- Bleeding disorder independent of leukemia

- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.

- No consent for biobanking.
Locations
Medizinische Universität Innsbruck
Innsbruck, Austria
Status: Recruiting
Contact: David Nachbaur, MD
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria
Status: Recruiting
Contact: Andreas Petzer, MD
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria
Status: Recruiting
Contact: Michael Girschikofsky, MD
Universitätsklinik für Innere Medizin III Salzburg
Salzburg, Austria
Status: Recruiting
Contact: Richard Greil, MD
Hanuschkrankenhaus Wien
Wien, Austria
Status: Recruiting
Contact: Elisabeth Koller, MD
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Status: Recruiting
Contact: Peter Reichardt, MD
Charité Universitätsmedizin Berlin
Berlin, Germany
Status: Recruiting
Contact: Jörg Westermann, MD
Vivantes Klinikum Neukölln
Berlin, Germany
Status: Recruiting
Contact: Maike de Wit, MD
Marienhospital Bochum-Herne
Bochum, Germany
Status: Recruiting
Contact: Beate Schultheis, MD
Medizinische Universitätsklinik Bochum
Bochum, Germany
Status: Recruiting
Contact: Wolf Schmiegel, MD
Universitätsklinikum Bonn
Bonn, Germany
Status: Recruiting
Contact: Marie von Lilienfeld-Toal, MD
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
Status: Recruiting
Contact: Jens Kersten, MD
Klinikum Bremen-Mitte gGmbH
Bremen, Germany
Status: Recruiting
Contact: Bernd Hertenstein, MD
Klinikum Darmstadt
Darmstadt, Germany
Status: Recruiting
Contact: Helga Bernhard, MD
Universitätsklinkum Düsseldorf
Düsseldorf, Germany
Status: Recruiting
Contact: Andrea Kündgen, MD
Kliniken Essen-Süd
Essen, Germany
Status: Recruiting
Contact: Peter Reimer, MD
Klinik für Onkologie, Gastroenterologie und Allg. Innere Medizin Esslingen
Esslingen, Germany
Status: Recruiting
Contact: Carsten Schwänen, MD
Malteser Krankenhaus St. Franziskus Hospital Flensburg
Flensburg, Germany
Status: Recruiting
Contact: Nadezda Basara, MD
Medizinische Universitätsklinik Freiburg
Freiburg, Germany
Status: Recruiting
Contact: Michael Lübbert, MD
Klinik der Justus-Liebig-Universität Gießen
Gießen, Germany
Status: Recruiting
Contact: Alexander Burchardt, MD
Wilhelm-Anton-Hospital gGmbH Goch
Goch, Germany
Status: Recruiting
Contact: Volker Runde, MD
Universitätsmedizin Göttingen
Göttingen, Germany
Status: Recruiting
Contact: Gerald Wulff, MD
Asklepios Klinik Altona
Hamburg, Germany
Status: Recruiting
Contact: Hans Salwender, MD
Universitätsklinikum Eppendorf
Hamburg, Germany
Status: Recruiting
Contact: Walter Fiedler, MD
Evangelisches Krankenhaus Hamm
Hamm, Germany
Status: Recruiting
Contact: Elisabeth Lange, MD
Klinikum Region Hannover GmbH
Hannover, Germany
Status: Recruiting
Contact: Hartmut Kirchner, MD
Medizinische Hochschule Hannover
Hannover, Germany
Status: Recruiting
Contact: Jürgen Krauter, MD
SLK Kliniken Heilbronn GmbH
Heilbronn, Germany
Status: Recruiting
Contact: Uwe Martens, MD
Universitätskliniken des Saarlandes
Homburg/Saar, Germany
Status: Recruiting
Contact: Michael Pfreundschuh, MD
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Status: Recruiting
Contact: Mark Ringhoffer, MD
Städtisches Krankenhaus Kiel GmbH
Kiel, Germany
Status: Recruiting
Contact: Heinz-August Horst, MD
Caritas Krankenhaus Lebach
Lebach, Germany
Status: Recruiting
Contact: Stephan Kremers, MD
Klinikum Lippe-Lemgo
Lemgo, Germany
Status: Recruiting
Contact: Tanja Hesse, MD
Märkische Kliniken GmbH Lüdenscheid
Lüdenscheid, Germany
Status: Recruiting
Contact: Gerhard Heil, MD
Universitätsklinikum der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Status: Recruiting
Contact: Wolfgang Herr, MD
Johannes Wesling Klinikum Minden
Minden, Germany
Status: Recruiting
Contact: Hans-Joachim Tischler, MD
Stauferklinikum Mutlangen
Mutlangen, Germany
Status: Recruiting
Contact: Holger Hebart, MD
Klinikum rechts der Isar der TU München
München, Germany
Status: Recruiting
Contact: Justus Duyster, MD
Klinikum Oldenburg
Oldenburg, Germany
Status: Recruiting
Contact: Doris Kraemer, MD
Pius Hospital Oldenburg
Oldenburg, Germany
Status: Recruiting
Contact: Frank Griesinger, MD
Klinikum Passau
Passau, Germany
Status: Recruiting
Contact: Thomas Südhoff, MD
Caritasklinik St. Theresia Saarbrücken
Saarbrücken, Germany
Status: Recruiting
Contact: Axel Matzdorff, MD
Diakonie-Klinikum Stuttgart
Stuttgart, Germany
Status: Recruiting
Contact: Else Heidemann, MD
Klinikum Stuttgart
Stuttgart, Germany
Status: Recruiting
Contact: Günther Mergenthaler, MD
Klinikum Mutterhaus der Borromäerinnen gGmbH Trier
Trier, Germany
Status: Recruiting
Contact: Rolf Mahlberg, MD
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Status: Recruiting
Contact: Heinz Kirchen, MD
Medizinische Universitätsklinik Tübingen
Tübingen, Germany
Status: Recruiting
Contact: Helmut Salih, MD
University Hospital of Ulm
Ulm, Germany
Status: Recruiting
Contact: Richard F Schlenk, MD - -49-731-500-45900 - richard.schlenk@uniklinik-ulm.de
Schwarzwald-Baar Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Status: Recruiting
Contact: Wolfram Brugger, MD
Helios Klinikum Wuppertal
Wuppertal, Germany
Status: Recruiting
Contact: Katrin Beckmann, MD
Start Date
May 2012
Completion Date
December 2019
Sponsors
University of Ulm
Source
University of Ulm
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page