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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03512197




Registration number
NCT03512197
Ethics application status
Date submitted
26/03/2018
Date registered
30/04/2018
Date last updated
20/08/2019

Titles & IDs
Public 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)
Scientific 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)
Secondary ID [1] 0 0
2017-003540-21
Secondary ID [2] 0 0
CPKC412E2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Midostaurin
Treatment: Drugs - Midostaurin Placebo
Treatment: Drugs - Chemotherapy

Experimental: Midostaurin + chemotherapy - Participants will receive Midostaurin 50mg twice a day until not achieving CR nor CRi without adequate hematologic recovery for continuation of treatment, intolerable toxicity, relapse or consent withdrawal plus chemotherapy whichever occurs first during induction and consolidation followed by midostaurin monotherapy for 12 cycles of 28 days cycle duration.Chemotherapy consists of daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation.

Placebo Comparator: Midostaurin Placebo + chemotherapy - Participants will receive matching placebo to midostaurin with same dose, plus chemotherapy. Chemotherapy consists of daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation


Treatment: Drugs: Midostaurin
After randomization, patients will receive midostaurin twice daily until not achieving CR nor CRi, relapse after CR or CRi, intolerable toxicity, or consent withdrawal

Treatment: Drugs: Midostaurin Placebo
After randomization, patients will receive midostaurin placebo twice daily until not achieving CR nor CRi, relapse after CR or CRi, intolerable toxicity, or consent withdrawal

Treatment: Drugs: Chemotherapy
Along with the study drug/placebo, chemotherapy will be give as welll: either Daunorubicin or Idarubicin and Cytarabine al take by i.v.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival (EFS) - EFS is defined as the time from randomization to failure to obtain a Complete Remission (CR) or Morphologic Complete Remission without hematopoietic recovery (CRi) with adequate blood count recovery(adequate for treatment continuation) in induction, relapse after CR or CRi with adequate blood count recovery or death due to any cause, whichever occurs first as assessed by the investigator
Timepoint [1] 0 0
From date of Randomization up to 5 years of follow-up
Secondary outcome [1] 0 0
Overall survival (OS) - OS is defined as the time from randomization to date of death due to any cause. Patients will enter the survival follow-up phase once they complete the safety follow up period (30 days after the last dose of midostaurin/placebo) in case of induction failure or have relapse during post-treatment follow-up. Patients will then be contacted by telephone every 3 months +/- 2 weeks or have a visit to follow up on their survival status
Timepoint [1] 0 0
Between randomization to date of death up to 5 years of follow-up of last patients
Secondary outcome [2] 0 0
Complete Remission (CR) with adequate blood count recovery rate - Assessment will be based on the IWG criteria for AML as per investigator assessment
Timepoint [2] 0 0
Between randomization to date of death up to 5 years of follow-up of last patients
Secondary outcome [3] 0 0
Percentage of patients with Minimal Residual Disease (MRD) negative status - Comparisons of the MRD levels between the end of the consolidation phase during the post-consolidation phase. The time to MRD negative status is defined as the time from randomization to first occurrence of MRD negativity
Timepoint [3] 0 0
Between start and three months after end of treatment
Secondary outcome [4] 0 0
Disease-free survival (DFS) - DFS is defined as the time from CR or CRi with adequate blood count recovery to relapse or death due to any cause. Patient who did not relapse nor die will be censored at the last adequate response assessment. Assessment will be based on the IWG criteria for AML as per investigator assessment
Timepoint [4] 0 0
From date of CR or CRi with adequate blood count recovery up to 5 years of follow-up
Secondary outcome [5] 0 0
Number of days from the first day of a chemotherapy cycle to first day neutrophils =0.5 x 10^9/L - The time to neutrophil recovery will be assessed for the following criteria: number of days from start of treatment to the first day neutrophils =0.5 x 10^9/L, Number of days from start of treatment to the first day neutrophils =1.0 x 10^9/L
Timepoint [5] 0 0
At maximum 93 days from induction therapy start
Secondary outcome [6] 0 0
Number of days from the first day of a chemotherapy cycle to first day platelets =50 x 10^9/L - Time to platelet recovery will be assessed for the following criteria: Number of days from start of treatment to the first day platelets =50 x 10^9/L, Number of days from start of treatment to the first day platelets =100 x 10^9/L
Timepoint [6] 0 0
At maximum 93 days from induction therapy start
Secondary outcome [7] 0 0
Plasma concentrations for midostaurin and its metabolitees: CGP52421 and CGP62221
Timepoint [7] 0 0
From date of Randomization up to 1.5 years of follow-up
Secondary outcome [8] 0 0
Cumulative incidence of relapse (CIR) - CIR is defined for patients with CR or CRi with adequate blood count recovery and is time from achieving CR or CRi with adequate blood count recovery until the onset of relapse from CR or CRi with adequate blood recovery. Patients without relapse are censored at the last adequate response assessment. Patients who died without relapse are counted as a competing cause of failure. Assessment will be based on the IWG criteria for AML as per investigator assessment
Timepoint [8] 0 0
From date of CR or CRi with adequate blood count recovery up to 5 years of follow-up
Secondary outcome [9] 0 0
Cumulative incidence of death (CID) - CID is defined for all patients achieving CR or CRi with adequate blood count recovery measured from the date of achievement of CR or CRi until the date of death due to any reason. Patients not known to have died are censored on the last contact date. Patients who experienced relapse are counted as a competing cause of failure. Assessment will be based on the IWG criteria for AML as per investigator assessment
Timepoint [9] 0 0
From date of CR or CRi with adequate blood count recovery up to 5 years of follow-up
Secondary outcome [10] 0 0
Number of days from date of randomization to first documented CR or CRi with adequate blood count recovery - Time to CR or CRi with adequate blood count recovery is defined as the time from randomization to CR or CRi with adequate blood count recovery whichever occurs first
Timepoint [10] 0 0
At maximum 93 days from induction therapy start
Secondary outcome [11] 0 0
Percentage of patients with MRD negative status during post-consolidation phase
Timepoint [11] 0 0
between start and three months after end of treatment
Secondary outcome [12] 0 0
Morphologic complete remission without hematopoietic recovery (CRi) with adequate blood count recovery rate - Assessment will be based on the IWG criteria for AML as per investigator assessment
Timepoint [12] 0 0
At maximum 93 days from induction therapy start
Secondary outcome [13] 0 0
Number of days from day 1 of commencing induction therapy to first day neutrophils =1.0 x 10^9/L
Timepoint [13] 0 0
At maximum 93 days from induction therapy start
Secondary outcome [14] 0 0
Number of days from day 1 of commencing induction therapy to first day platelets =100 x 10^9/L
Timepoint [14] 0 0
From date of Randomization up to 5 years of follow-up
Secondary outcome [15] 0 0
Number of days from date of randomization to first documented MRD negativity
Timepoint [15] 0 0
From date of Randomization up to 5 years of follow-up
Secondary outcome [16] 0 0
AUC0-t: Pharmacokinetic (PK) parameter for midostaurin and its metabolites: CGP52421 and CGP62221 - The AUC from time zero to a measurable concentration sampling time (t) (mass x time x volume-1). Note: as the last sampling time is at 12 h, AUC0-12h will be determined after the first dose
Timepoint [16] 0 0
From date of Randomization up to 1.5 years of follow-up
Secondary outcome [17] 0 0
AUClast: Pharmacokinetic (PK) parameter for midostaurin and its metabolites: CGP52421 and CGP62221 - The AUC from time zero to the last measurable concentration sampling time after the first dose
Timepoint [17] 0 0
From date of Randomization up to 1.5 years of follow-up
Secondary outcome [18] 0 0
Cmax: Pharmacokinetic (PK) parameter for midostaurin and its metabolites: CGP52421 and CGP62221 - The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after the first dose administration
Timepoint [18] 0 0
From date of Randomization up to 1.5 years of follow-up
Secondary outcome [19] 0 0
Tmax: Pharmacokinetic (PK) parameter for midostaurin and its metabolites: CGP52421 and CGP62221 - The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration
Timepoint [19] 0 0
From date of Randomization up to 1.5 years of follow-up
Secondary outcome [20] 0 0
Change from baseline score for each time point for the FACT-Leu - The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL.
Timepoint [20] 0 0
From date of Randomization up to 5 years of follow-up
Secondary outcome [21] 0 0
Change from baseline score for each time point for the EQ5D-5L (a visual analogue scale (VAS)) - The EQ5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient is asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a Visual Analogue Scale (VAS), where the patient is asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.
Timepoint [21] 0 0
From date of Randomization up to 5 years of follow-up

Eligibility
Key inclusion criteria
1. Diagnosis of AML (=20% blasts in the bone marrow based on WHO 2016 classification).
Patients with APL with PML-RARA are not eligible.

2. Suitability for intensive induction chemotherapy in the judgment of the investigator

3. Documented absence of an ITD and TKD activating mutation at codons D835 and I836 in
the FLT3 gene, as determined by analysis in a Novartis designated laboratory using a
validated clinical trial assay with clinical cutoff of 0.05 mutant to wild type signal
ratio

4. Age =18 years

5. Laboratory values that indicate adequate organ function assessed locally at the
screening visit
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Central nervous system (CNS) leukemia

2. Therapy-related secondary AML

3. Isolated extramedullary leukemia

4. Prior therapy for leukemia or myelodysplasia

5. AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g.,
azacytidine or decitabine)

6. Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Prahran
Recruitment hospital [4] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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California
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Illinois
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Massachusetts
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Oregon
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Utah
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Argentina
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Buenos Aires
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Roeselare
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Brazil
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RS
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Brazil
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SP
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Brazil
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Sao Paulo
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Bulgaria
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Plovdiv
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Sofia
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Pierre Benite Cedex
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Toulouse Cedex 9
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France
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Vandoeuvre Les Nancy
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Bavaria
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Bochum
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Eschweiler
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Essen Werden
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Giessen
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Lubeck
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Muenchen
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Osnabrueck
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Paderborn
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Rostock
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Siegen
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Stuttgart
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Ulm
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Winnenden
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Wuerzburg
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Wuppertal
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Zwickau
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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AL
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Italy
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AN
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Italy
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BG
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Italy
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BS
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Italy
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CT
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Italy
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Lazio
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Italy
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MI
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Italy
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MO
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Italy
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PA
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Italy
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PC
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Italy
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PE
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Italy
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RC
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Italy
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RM
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Italy
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TA
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Italy
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TO
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Italy
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VI
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Italy
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Napoli
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Italy
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Perugia
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Japan
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Aichi
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Ehime
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Fukuoka
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Fukushima
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Gifu
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Japan
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Hiroshima
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Kochi
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Kyoto
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Japan
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Nagasaki
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tochigi
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Tokyo
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Aomori
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Japan
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Yamagata
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Norway
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Bergen
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Norway
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Oslo
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Poland
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Gdansk
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Portugal
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Lisboa
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Portugal
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Porto
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Spain
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Andalucia
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Spain
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Castilla Y Leon
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Extremadura
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Spain
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Pais Vasco
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Bern
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Switzerland
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Zurich
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Taiwan
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Chiayi Hsien
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Taiwan
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Taoyuan/ Taiwan ROC
Country [131] 0 0
Taiwan
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Kaohsiung City
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Taiwan
State/province [132] 0 0
Taipei
Country [133] 0 0
Turkey
State/province [133] 0 0
Adana
Country [134] 0 0
Turkey
State/province [134] 0 0
Ankara
Country [135] 0 0
Turkey
State/province [135] 0 0
Aydin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is 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 will evaluate 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.
Trial website
https://clinicaltrials.gov/show/NCT03512197
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.emai@novarti.som
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03512197