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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03512197
Registration number
NCT03512197
Ethics application status
Date submitted
26/03/2018
Date registered
30/04/2018
Date last updated
21/08/2023
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)
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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)
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Secondary ID [1]
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2017-003540-21
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Secondary ID [2]
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CPKC412E2301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML)
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Midostaurin
Treatment: Drugs - Placebo
Treatment: Drugs - Chemotherapy
Experimental: Midostaurin + chemotherapy - 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.
Placebo Comparator: Placebo + chemotherapy - 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
Treatment: Drugs: Midostaurin
Midostaurin was provided as 25 mg capsules 8PC, was supplied as double-blind in blister packs and taken orally.
Treatment: Drugs: Placebo
Placebo was provided as 25 mg soft gelatin capsules 8PC, was supplied as double-blind in blister packs and taken orally.
Treatment: Drugs: Chemotherapy
Along with the study drug/placebo, chemotherapy was given as well: either Daunorubicin or Idarubicin and Cytarabine - all taken by i.v.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival (EFS)
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Assessment method [1]
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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.
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Timepoint [1]
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From date of Randomization up to approx. 30 months
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Secondary outcome [1]
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Overall Survival (OS) (Key Secondary)
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Assessment method [1]
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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.
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Timepoint [1]
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Between randomization to date of death up to approx. 30 months
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Secondary outcome [2]
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Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate.
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Assessment method [2]
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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).
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Timepoint [2]
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At maximum 93 days from induction therapy start
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Secondary outcome [3]
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Percentage of Participants With Minimal Residual Disease (MRD) Negative Status
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Assessment method [3]
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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.
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Timepoint [3]
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from start of treatment up to end of post-consolidation (approximately 17 months)
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Secondary outcome [4]
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Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase
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Assessment method [4]
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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.
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Timepoint [4]
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from start of post-consolidation to end of post-consolidation phase (up to 12 months)
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Secondary outcome [5]
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Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry
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Assessment method [5]
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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.
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Timepoint [5]
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From date of Randomization up to approx. 17 months
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Secondary outcome [6]
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Disease-free Survival (DFS)
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Assessment method [6]
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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
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Timepoint [6]
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From date of CR or CRi with adequate blood count recovery up to approx. 30 months
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Secondary outcome [7]
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Cumulative Incidence of Relapse (CIR)
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Assessment method [7]
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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.
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Timepoint [7]
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From date of CR or CRi with adequate blood count recovery up to approx. 30 months
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Secondary outcome [8]
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Cumulative Incidence of Death (CID)
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Assessment method [8]
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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.
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Timepoint [8]
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0
From date of CR or CRi with adequate blood count recovery up to approx. 30 months
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Secondary outcome [9]
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Time to CR or CRi With Adequate Blood Count Recovery
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Assessment method [9]
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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
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Timepoint [9]
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At maximum 93 days from induction therapy start
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Secondary outcome [10]
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Time to Partial and Full Neutrophil Recovery
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Assessment method [10]
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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
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Timepoint [10]
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At maximum 93 days from induction therapy start
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Secondary outcome [11]
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Time to Partial and Full Platelet Recovery
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Assessment method [11]
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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.
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Timepoint [11]
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At maximum 93 days from induction therapy start
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Secondary outcome [12]
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Plasma Concentrations for Midostaurin and Its Metabolites: CGP52421 and CGP62221 for Non-poor Metabolizers
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Assessment method [12]
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Serial pharmacokinetics (PK) samples were collected in Non-poor metabolizer participants to assess the plasma concentrations of midostaurin, CGP52421 and CGP62221.
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Timepoint [12]
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from Induction (IND) phase 0hr (predose) to Post-consolidation phase (POSTCONS) 12hr
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Secondary outcome [13]
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AUC0-t: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8
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Assessment method [13]
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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
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Timepoint [13]
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0 - 12 hrs
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Secondary outcome [14]
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AUClast: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8
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Assessment method [14]
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The AUC from time zero to the last measurable concentration sampling time after the first dose reported at Cycle 1, Day 8
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Timepoint [14]
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0 - 12 hrs
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Secondary outcome [15]
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Cmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8
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Assessment method [15]
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The maximum (peak) observed plasma drug concentration after the first dose administration reported at Cycle 1, Day 8
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Timepoint [15]
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0 - 12 hrs
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Secondary outcome [16]
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Tmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8
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Assessment method [16]
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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
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Timepoint [16]
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0 - 12 hrs
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Secondary outcome [17]
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Total Score for Each Time Point for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
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Assessment method [17]
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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.
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Timepoint [17]
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From date of Randomization up to approx. 18 months
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Secondary outcome [18]
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Scores for Each Time Point for the EQ5D-5L (a Visual Analogue Scale (VAS))
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Assessment method [18]
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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.
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Timepoint [18]
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From date of Randomization up to approx. 18 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/02/2021
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Sample size
Target
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Accrual to date
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Final
511
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment hospital [2]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [3]
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Novartis Investigative Site - Prahran
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Recruitment hospital [4]
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Novartis Investigative Site - Murdoch
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3181 - Prahran
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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United States of America
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Massachusetts
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United States of America
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Oregon
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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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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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Sofia
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Czechia
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Brno - Bohunice
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Czechia
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State/province [16]
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Plzen-Bory
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France
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Bayonne Cedex
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France
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Angers Cedex 1
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France
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Avignon
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France
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Dijon
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France
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Lille Cedex
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France
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Nantes Cedex 1
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France
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Paris
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France
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Pierre Benite
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France
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Toulouse
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Germany
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Bavaria
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Germany
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Brandenburg
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Germany
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Bad Saarow
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Braunschweig
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Germany
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Darmstadt
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Germany
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Duesseldorf
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Germany
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Duisburg
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Germany
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Eschweiler
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Germany
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Essen Werden
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Germany
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Flensburg
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Germany
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Giessen
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Germany
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Gottingen
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Germany
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Hamburg
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Germany
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Hannover
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Homburg
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Karlsruhe
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Luebeck
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Osnabrueck
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Germany
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Paderborn
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Germany
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Rostock
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Germany
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Siegen
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Germany
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Stuttgart
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Germany
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Ulm
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Germany
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Wuerzburg
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Germany
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Zwickau
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0
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Israel
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Haifa
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0
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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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Italy
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AL
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Italy
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AN
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0
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Italy
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BG
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0
0
Italy
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0
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BS
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Country [66]
0
0
Italy
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0
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CT
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0
0
Italy
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MI
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0
0
Italy
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MO
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0
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Italy
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PA
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0
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Italy
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PC
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Italy
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Italy
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Italy
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TA
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Italy
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TO
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VI
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Aichi
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Bergen
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Oslo
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Aydin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03512197
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03512197
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