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Spots Global Cancer Trial Database for A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

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Trial Identification

Brief Title: A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

Official Title: A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

Study ID: NCT03512197

Study Description

Brief Summary: The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR\<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off). This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR\<0.05) AML.

Detailed Description: This was a multi-center, multinational, randomized, double-blind Phase III study using a group sequential design. Subjects were stratified according to age (\<60 vs. ≥ 60 years). Subjects within each stratum were randomized in a 1:1 ratio into one of two treatment arms: Midostaurin + chemotherapy 'or' Placebo + chemotherapy. The study consisted of the following phases: Screening/randomization phase: Subjects had to sign informed consent form before screening for enrollment. Subjects started chemotherapy at day 1 and were randomized at day 8. Induction phase: All subjects received at least one cycle (28 days) of induction therapy with continuous infusion cytarabine (D1 - D7) and daunorubicin or idarubicin (D1 - D3) (induction 1). Subjects who did not achieve CR or CRi with adequate blood count recovery after Induction 1 received a second cycle with intermediate-dose cytarabine (D1 - D3) and daunorubicin or idarubicin (D1 - D3) (induction 2). Subjects who did not achieve CR or CRi with adequate blood recovery after induction 2 discontinued study treatment and were followed for survival. Consolidation phase: Subjects who achieved CR or CRi with adequate blood count recovery after induction with one or two cycles of induction proceeded to consolidation therapy with either 3 or 4 cycles respectively of intermediate-dose cytarabine (D1 - D3), or to Hematopoietic Stem Cells Transplantation (HSCT) with or without preceding consolidation cycles. Post-consolidation phase: Subjects who maintained CR or CRi with adequate blood count recovery at the end of the consolidation phase received 12 cycles (28 days/cycle) of continuous therapy with midostaurin or placebo twice daily at 50 mg. Subjects who underwent HSCT after achieving CR or CRi with adequate blood count recovery received midostaurin or placebo twice daily 50 mg post-transplant therapy, continuously, for up to 12 cycles (28 days/cycle). Post HSCT post-consolidation therapy began \>30 days but not later than 100 days following HSCT. Follow-up phase: All enrolled subjects were followed through the treatment period and until relapse/treatment failure, thereafter for start of new line of therapy and survival.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Chicago Medical Center ., Chicago, Illinois, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Oregon Health and Science Univ, Portland, Oregon, United States

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Novartis Investigative Site, Westmead, New South Wales, Australia

Novartis Investigative Site, Woolloongabba, Queensland, Australia

Novartis Investigative Site, Prahran, Victoria, Australia

Novartis Investigative Site, Murdoch, Western Australia, Australia

Novartis Investigative Site, Linz, , Austria

Novartis Investigative Site, Vienna, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Antwerpen, , Belgium

Novartis Investigative Site, Brugge, , Belgium

Novartis Investigative Site, Roeselare, , Belgium

Novartis Investigative Site, Porto Alegre, RS, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Sao Paulo, , Brazil

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Brno - Bohunice, , Czechia

Novartis Investigative Site, Plzen-Bory, , Czechia

Novartis Investigative Site, Bayonne, Bayonne Cedex, France

Novartis Investigative Site, Angers Cedex 1, , France

Novartis Investigative Site, Avignon, , France

Novartis Investigative Site, Dijon, , France

Novartis Investigative Site, Lille Cedex, , France

Novartis Investigative Site, Nantes Cedex 1, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Pierre Benite, , France

Novartis Investigative Site, Toulouse, , France

Novartis Investigative Site, Regensburg, Bavaria, Germany

Novartis Investigative Site, Schwerin, Brandenburg, Germany

Novartis Investigative Site, Bad Saarow, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Bochum, , Germany

Novartis Investigative Site, Bonn, , Germany

Novartis Investigative Site, Braunschweig, , Germany

Novartis Investigative Site, Darmstadt, , Germany

Novartis Investigative Site, Duesseldorf, , Germany

Novartis Investigative Site, Duisburg, , Germany

Novartis Investigative Site, Eschweiler, , Germany

Novartis Investigative Site, Essen Werden, , Germany

Novartis Investigative Site, Flensburg, , Germany

Novartis Investigative Site, Giessen, , Germany

Novartis Investigative Site, Gottingen, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hannover, , Germany

Novartis Investigative Site, Homburg, , Germany

Novartis Investigative Site, Karlsruhe, , Germany

Novartis Investigative Site, Kiel, , Germany

Novartis Investigative Site, Leipzig, , Germany

Novartis Investigative Site, Luebeck, , Germany

Novartis Investigative Site, Magdeburg, , Germany

Novartis Investigative Site, Mainz, , Germany

Novartis Investigative Site, Muenchen, , Germany

Novartis Investigative Site, Osnabrueck, , Germany

Novartis Investigative Site, Paderborn, , Germany

Novartis Investigative Site, Rostock, , Germany

Novartis Investigative Site, Siegen, , Germany

Novartis Investigative Site, Stuttgart, , Germany

Novartis Investigative Site, Stuttgart, , Germany

Novartis Investigative Site, Ulm, , Germany

Novartis Investigative Site, Wuerzburg, , Germany

Novartis Investigative Site, Zwickau, , Germany

Novartis Investigative Site, Haifa, , Israel

Novartis Investigative Site, Petach Tikva, , Israel

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Alessandria, AL, Italy

Novartis Investigative Site, Ancona, AN, Italy

Novartis Investigative Site, Bergamo, BG, Italy

Novartis Investigative Site, Brescia, BS, Italy

Novartis Investigative Site, Catania, CT, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Modena, MO, Italy

Novartis Investigative Site, Palermo, PA, Italy

Novartis Investigative Site, Piacenza, PC, Italy

Novartis Investigative Site, Pescara, PE, Italy

Novartis Investigative Site, Perugia, PG, Italy

Novartis Investigative Site, Reggio Calabria, RC, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Taranto, TA, Italy

Novartis Investigative Site, Torino, TO, Italy

Novartis Investigative Site, Vicenza, VI, Italy

Novartis Investigative Site, Nagoya-city, Aichi, Japan

Novartis Investigative Site, Matsuyama-city, Ehime, Japan

Novartis Investigative Site, Fukuoka city, Fukuoka, Japan

Novartis Investigative Site, Fukushima city, Fukushima, Japan

Novartis Investigative Site, Gifu shi, Gifu, Japan

Novartis Investigative Site, Fukuyama, Hiroshima, Japan

Novartis Investigative Site, Tsukuba city, Ibaraki, Japan

Novartis Investigative Site, Isehara, Kanagawa, Japan

Novartis Investigative Site, Nagasaki-city, Nagasaki, Japan

Novartis Investigative Site, Okayama city, Okayama, Japan

Novartis Investigative Site, Hirakata-city, Osaka, Japan

Novartis Investigative Site, Osaka Sayama, Osaka, Japan

Novartis Investigative Site, Hamamatsu, Shizuoka, Japan

Novartis Investigative Site, Shimotsuke, Tochigi, Japan

Novartis Investigative Site, Bunkyo ku, Tokyo, Japan

Novartis Investigative Site, Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site, Aomori, , Japan

Novartis Investigative Site, Kyoto, , Japan

Novartis Investigative Site, Osaka, , Japan

Novartis Investigative Site, Yamagata, , Japan

Novartis Investigative Site, Bergen, , Norway

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Gdansk, , Poland

Novartis Investigative Site, Lisboa, , Portugal

Novartis Investigative Site, Porto, , Portugal

Novartis Investigative Site, Cordoba, Andalucia, Spain

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Novartis Investigative Site, Caceres, Extremadura, Spain

Novartis Investigative Site, Barakaldo, Pais Vasco, Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Zaragoza, , Spain

Novartis Investigative Site, Bern, , Switzerland

Novartis Investigative Site, Zurich, , Switzerland

Novartis Investigative Site, Putzu City, Chiayi Hsien, Taiwan

Novartis Investigative Site, Kuei Shan Chiang, Taoyuan Taiwan ROC, Taiwan

Novartis Investigative Site, Kaohsiung City, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Adana, , Turkey

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Aydin, , Turkey

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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