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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)

Primary Purpose

Acute Myeloid Leukemia (AML)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Midostaurin

Placebo

Chemotherapy

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Newly diagnosed FLT3-mutation negative, PKC412, midostaurin, cytarabine, daunorubicin, idarubicin, acute myeloid leukemia, AML, FLT3-MN (SR<0.05), combination treatment, induction failure, event free survival, EFS, minimal residual disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL with PML-RARA are not eligible.
Suitability for intensive induction chemotherapy in the judgment of the investigator
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
Age ≥18 years
Laboratory values that indicate adequate organ function assessed locally at the screening visit

Exclusion Criteria:

Central nervous system (CNS) leukemia
Therapy-related secondary AML
Isolated extramedullary leukemia
Prior therapy for leukemia or myelodysplasia
AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine)
Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Midostaurin + chemotherapy

Placebo + chemotherapy

Arm Description

Participants received Midostaurin in Induction 50mg twice daily on Day 8 until 48 hrs before start of next cycle. During Induction 2 and consolidation 50mg twice daily on Day 4 until 48 hrs before start of next cycle. During post-consolidation 50mg twice daily for 28 consecutive days of each 28-day treatment cycle up to 12 cycles. For participants who could not tolerate the protocol-specified dosing schedule, dose interruptions and/or reductions were either recommended or mandated allowing participants to continue the study treatment. Chemotherapy consisted of daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation.

Participants received matching placebo to midostaurin with same dose, plus chemotherapy. Chemotherapy consisted of daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

EFS was defined as the time from randomization to failure to obtain a complete remission (CR) or Complete remission with incomplete hematologic recovery (CRi) with adequate blood count recovery in induction, relapse after CR or CRi with adequate blood count recovery or death due to any cause, whichever occurred first as assessed by the investigator.

Secondary Outcome Measures

Overall Survival (OS) (Key Secondary)

OS was defined as the time from randomization to date of death due to any cause. Patients entered the survival follow-up phase once they completed the safety follow up period (30 days after the last dose of midostaurin/placebo) in case of induction failure or if they had relapsed during post-treatment follow-up. Patients were then contacted by telephone every 3 months +/- 2 weeks or had a visit to follow up on their survival status, per Kaplan-Meier estimates.

Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate.

Assessment was based on the International Working Group (IWG) criteria for AML as per investigator assessment. CR: Bone marrow: < 5% blasts no blasts with Auer rods; Peripheral blood: neutrophils ≥ 1.0 x 109/L platelets ≥ 100 x 109/L, no blasts; No evidence of extramedullary disease (such as central nervous system (CNS) or soft tissue involvement); Transfusion independent. CRi with adequate blood count recovery is defined as the following: Bone marrow < 5% blasts no blasts with Auer rods Peripheral blood Neutrophils >= 1.0 x 109/L and 50 x 109/L <=platelets < 100 x 109/L no blasts No evidence of extramedullary disease (such as CNS or soft tissue involvement).

Percentage of Participants With Minimal Residual Disease (MRD) Negative Status

MRD- rate was defined as the rate of participants reaching MRD at any timepoint. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment.

Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase

MRD- rate was defined as the rate of participants reaching MRD at any timepoint during Post-consolidation phase. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment.

Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry

Time to MRD- is defined as time from randomization to first occurrence of MRD-. Participants with leukemic blasts below 0.1% were considered as MRD-negative based on leukemia-associated immunophenotype (LAIP). MRD was derived from bone marrow and blood data using cellular and molecular technologies and MRD status was measured using the flow cytometry assessments for LAIP irrespective of the investigator's overall clinical response assessment.

Disease-free Survival (DFS)

DFS as measured from the date of first CR or CRi with adequate blood count recovery to relapse or death due to any cause, whichever occurred first. Participants who did not relapse nor die were censored at the last adequate response assessment. Assessment was based on the IWG criteria for AML as per investigator assessment

Cumulative Incidence of Relapse (CIR)

Cumulative Incidence of Relapse (CIR) was defined for participants with CR or CRi with adequate blood count recovery and was the time from achieving the CR or CRi with adequate blood count recovery until the onset of relapse from CR or CRi with adequate blood recovery. Participants without relapse were censored at the last adequate response assessment. Participants who died without relapse were counted as a competing cause of failure.

Cumulative Incidence of Death (CID)

Cumulative Incidence of Death (CID) was defined for all participants 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. Participants not known to have died were censored on the last contact date. Participants who experienced relapse were counted as a competing cause of failure.

Time to CR or CRi With Adequate Blood Count Recovery

Time to CR or CRi with adequate blood count recovery was defined as the time from randomization to CR or CRi with adequate blood count recovery whichever occurred first

Time to Partial and Full Neutrophil Recovery

The time to neutrophil recovery was assessed for the following criteria: Partial neutrophil recovery: Number of days from start of treatment to the first day neutrophils ≥0.5 x 10^9/L. Full neutrophil recovery: Number of days from start of treatment to the first day neutrophils ≥1.0 x 10^9/L

Time to Partial and Full Platelet Recovery

Time to platelet recovery was assessed for the following criteria: Partial platelet recovery: Number of days from start of treatment to the first day platelets ≥50 x 10^9/L. Full platelet recovery: Number of days from start of treatment to the first day platelets ≥100 x 10^9/L.

Plasma Concentrations for Midostaurin and Its Metabolites: CGP52421 and CGP62221 for Non-poor Metabolizers

Serial pharmacokinetics (PK) samples were collected in Non-poor metabolizer participants to assess the plasma concentrations of midostaurin, CGP52421 and CGP62221.

AUC0-t: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

The AUC from time zero to a measurable concentration sampling time (t) (mass x time x volume-1). Note: as the last sampling time was at 12 h, AUC0-12h was determined after the first dose, reported at Cycle 1, Day 8

AUClast: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

The AUC from time zero to the last measurable concentration sampling time after the first dose reported at Cycle 1, Day 8

Cmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

The maximum (peak) observed plasma drug concentration after the first dose administration reported at Cycle 1, Day 8

Tmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration reported at Cycle 1, Day 8

Total Score for Each Time Point for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)

The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better health-related quality of life ( HRQoL). Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL.

Scores 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.

Full Information

NCT ID

NCT03512197

First Posted

March 26, 2018

Last Updated

August 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03512197

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 Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 20, 2018 (Actual)

Primary Completion Date

February 12, 2021 (Actual)

Study Completion Date

February 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia (AML)

Keywords

Newly diagnosed FLT3-mutation negative, PKC412, midostaurin, cytarabine, daunorubicin, idarubicin, acute myeloid leukemia, AML, FLT3-MN (SR<0.05), combination treatment, induction failure, event free survival, EFS, minimal residual disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

511 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Midostaurin + chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Placebo + chemotherapy

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Midostaurin

Other Intervention Name(s)

PKC412

Intervention Description

Midostaurin was provided as 25 mg capsules 8PC, was supplied as double-blind in blister packs and taken orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was provided as 25 mg soft gelatin capsules 8PC, was supplied as double-blind in blister packs and taken orally.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Along with the study drug/placebo, chemotherapy was given as well: either Daunorubicin or Idarubicin and Cytarabine - all taken by i.v.

Primary Outcome Measure Information:

Title

Event Free Survival (EFS)

Description

Time Frame

From date of Randomization up to approx. 30 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS) (Key Secondary)

Description

Time Frame

Between randomization to date of death up to approx. 30 months

Title

Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate.

Description

Time Frame

At maximum 93 days from induction therapy start

Title

Percentage of Participants With Minimal Residual Disease (MRD) Negative Status

Description

Time Frame

from start of treatment up to end of post-consolidation (approximately 17 months)

Title

Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase

Description

Time Frame

from start of post-consolidation to end of post-consolidation phase (up to 12 months)

Title

Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry

Description

Time Frame

From date of Randomization up to approx. 17 months

Title

Disease-free Survival (DFS)

Description

Time Frame

From date of CR or CRi with adequate blood count recovery up to approx. 30 months

Title

Cumulative Incidence of Relapse (CIR)

Description

Time Frame

From date of CR or CRi with adequate blood count recovery up to approx. 30 months

Title

Cumulative Incidence of Death (CID)

Description

Time Frame

From date of CR or CRi with adequate blood count recovery up to approx. 30 months

Title

Time to CR or CRi With Adequate Blood Count Recovery

Description

Time to CR or CRi with adequate blood count recovery was defined as the time from randomization to CR or CRi with adequate blood count recovery whichever occurred first

Time Frame

At maximum 93 days from induction therapy start

Title

Time to Partial and Full Neutrophil Recovery

Description

Time Frame

At maximum 93 days from induction therapy start

Title

Time to Partial and Full Platelet Recovery

Description

Time Frame

At maximum 93 days from induction therapy start

Title

Plasma Concentrations for Midostaurin and Its Metabolites: CGP52421 and CGP62221 for Non-poor Metabolizers

Description

Serial pharmacokinetics (PK) samples were collected in Non-poor metabolizer participants to assess the plasma concentrations of midostaurin, CGP52421 and CGP62221.

Time Frame

from Induction (IND) phase 0hr (predose) to Post-consolidation phase (POSTCONS) 12hr

Title

AUC0-t: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

Description

Time Frame

0 - 12 hrs

Title

AUClast: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

Description

The AUC from time zero to the last measurable concentration sampling time after the first dose reported at Cycle 1, Day 8

Time Frame

0 - 12 hrs

Title

Cmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

Description

The maximum (peak) observed plasma drug concentration after the first dose administration reported at Cycle 1, Day 8

Time Frame

0 - 12 hrs

Title

Tmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8

Description

The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration reported at Cycle 1, Day 8

Time Frame

0 - 12 hrs

Title

Total Score for Each Time Point for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)

Description

Time Frame

From date of Randomization up to approx. 18 months

Title

Scores for Each Time Point for the EQ5D-5L (a Visual Analogue Scale (VAS))

Description

Time Frame

From date of Randomization up to approx. 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL with PML-RARA are not eligible. Suitability for intensive induction chemotherapy in the judgment of the investigator 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 Age ≥18 years Laboratory values that indicate adequate organ function assessed locally at the screening visit Exclusion Criteria: Central nervous system (CNS) leukemia Therapy-related secondary AML Isolated extramedullary leukemia Prior therapy for leukemia or myelodysplasia AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g., azacytidine or decitabine) Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of Chicago Medical Center .

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Oregon Health and Science Univ

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1118AAT

Country

Argentina

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Novartis Investigative Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

ZIP/Postal Code

01221 900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Brno - Bohunice

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen-Bory

ZIP/Postal Code

30599

Country

Czechia

Facility Name

Novartis Investigative Site

City

Bayonne

State/Province

Bayonne Cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Angers Cedex 1

ZIP/Postal Code

49033

Country

France

Facility Name

Novartis Investigative Site

City

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

State/Province

Brandenburg

ZIP/Postal Code

19049

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44892

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Eschweiler

ZIP/Postal Code

52249

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen Werden

ZIP/Postal Code

45239

Country

Germany

Facility Name

Novartis Investigative Site

City

Flensburg

ZIP/Postal Code

24939

Country

Germany

Facility Name

Novartis Investigative Site

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24116

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrueck

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Paderborn

ZIP/Postal Code

33098

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Zwickau

ZIP/Postal Code

08060

Country

Germany

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Alessandria

State/Province

ZIP/Postal Code

15100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Piacenza

State/Province

ZIP/Postal Code

29100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

State/Province

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Taranto

State/Province

ZIP/Postal Code

74100

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsuyama-city

State/Province

Ehime

ZIP/Postal Code

790-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukushima city

State/Province

Fukushima

ZIP/Postal Code

960 1295

Country

Japan

Facility Name

Novartis Investigative Site

City

Gifu shi

State/Province

Gifu

ZIP/Postal Code

500 8513

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuyama

State/Province

Hiroshima

ZIP/Postal Code

720-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsukuba city

State/Province

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

Novartis Investigative Site

City

Isehara

State/Province

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagasaki-city

State/Province

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama city

State/Province

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Hirakata-city

State/Province

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka Sayama

State/Province

Osaka

ZIP/Postal Code

589 8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

432-8580

Country

Japan

Facility Name

Novartis Investigative Site

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo ku

State/Province

Tokyo

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Novartis Investigative Site

City

Aomori

ZIP/Postal Code

030 8553

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto

ZIP/Postal Code

606 8507

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Yamagata

ZIP/Postal Code

990 9585

Country

Japan

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

NO-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1099 023

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barakaldo

State/Province

Pais Vasco

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Putzu City

State/Province

Chiayi Hsien

ZIP/Postal Code

61363

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kuei Shan Chiang

State/Province

Taoyuan Taiwan ROC

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Aydin

ZIP/Postal Code

09100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1104

Description

A Plain Language Trial Summary is available on novctrd.com

Learn more about this trial

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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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)

Acute Myeloid Leukemia (AML)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial