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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/NCT04027309




Registration number
NCT04027309
Ethics application status
Date submitted
18/07/2019
Date registered
19/07/2019
Date last updated
15/06/2023

Titles & IDs
Public title
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Scientific title
A Phase 3, Multicenter, Open-label, Randomized, Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)
Secondary ID [1] 0 0
2018-000624-33
Secondary ID [2] 0 0
HO156
Universal Trial Number (UTN)
Trial acronym
HOVON 156 AML
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Myelodysplastic Syndrome With Excess Blasts-2 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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Blood 0 0 0 0
Anaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Active Comparator: Arm A (Midostaurin) - Midostaurin (50 mg BID PO) - Cycle 1 (day 8-21), Cycle 2 (day 8-21), Consolidation (only during chemo consolidation (day 8-21 - with max of 3 cycles), Maintenance (day 1-365)

Experimental: Arm B (Gilteritinib) - Gilteritinib (120 mg QD PO) - Cycle 1 (day 8-21), Cycle 2 (day 8-21), Consolidation (only during chemo consolidation (day 8-21 - with max of 3 cycles), Maintenance (day 1-365)


Treatment: Drugs: Gilteritinib
Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin

Treatment: Drugs: Midostaurin
Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival (EFS)
Timepoint [1] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Approximately up to 68 months following first patient enrollment
Secondary outcome [2] 0 0
CR rate after remission induction
Timepoint [2] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [3] 0 0
CR and CRi rates after induction cycle 1 and after induction cycle 2
Timepoint [3] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [4] 0 0
Relapse-free survival (RFS)
Timepoint [4] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [5] 0 0
Cumulative incidence of relapse (CIR) after CR
Timepoint [5] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [6] 0 0
Cumulative incidence of death (CID) after CR
Timepoint [6] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [7] 0 0
CR without minimal residual disease (CRMRD-) rate after induction cycle 2
Timepoint [7] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [8] 0 0
Frequency and severity of adverse events according to CTCAE v5.0
Timepoint [8] 0 0
Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug
Secondary outcome [9] 0 0
Time to hematopoietic recovery after each chemotherapy treatment cycle
Timepoint [9] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [10] 0 0
Allogeneic stem cell transplantation (allo-SCT) rate
Timepoint [10] 0 0
Approximately up to 45 months following first patient enrollment
Secondary outcome [11] 0 0
Individual domain scores and visual analogue scale (VAS) score of the European Quality of Life 5 Dimensions (EQ-5D-5L) Questionnaire
Timepoint [11] 0 0
At entry, 1st day of maintenance and every 3 months during maintenance until relapse or treatment discontinuation (approximately up to 68 months following first patient enrollment)
Secondary outcome [12] 0 0
Individual subdomain scores and the global health status/QoL scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Timepoint [12] 0 0
At entry, 1st day of maintenance and every 3 months during maintenance until relapse or treatment discontinuation (approximately up to 68 months following first patient enrollment)

Eligibility
Key inclusion criteria
- Age =18 years

- Newly diagnosed AML or MDS with excess of blasts-2 (EB2) defined according to WHO
criteria (appendix A), with centrally documented FLT3 gene mutation (either TKD or ITD
or both). AML may be secondary to prior hematological disorders, including MDS, and/or
therapy-related. Patients may have had previous treatment with erythropoiesis
stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of
MDS. ESA and HMAs have to be stopped at least four weeks before registration.

- FLT3 mutation as assessed by DNA fragment analysis PCR for FLT3-ITD and FLT3-TKD
mutation. Positivity is defined as a FLT3-ITD or FLT3-TKD / FLT3-WT ratio of = 0.05
(5%).

- Considered to be eligible for intensive chemotherapy

- Patient is suitable for oral administration of study drug

- WHO/ECOG performance status = 2

- Adequate hepatic function as evidenced by

- Serum total bilirubin = 2.5 × upper limit of normal (ULN) unless considered due
to leukemic involvement following written approval by the (co) Principal
Investigator

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase (ALP) = 3.0 × ULN, unless considered due to leukemic involvement
following written approval by the (co) Principal Investigator

- Adequate renal function as defined by creatinine clearance > 40 mL/min based on the
Cockroft-Gault glomerular filtration rate (GFR)

- Written informed consent

- Patient is capable of giving informed consent

- Female patient must either:

- Be of nonchildbearing potential:

- Postmenopausal (defined as at least 1 year without any menses) prior to
screening, or

- Documented surgically sterile or status posthysterectomy (at least 1 month
prior to screening)

- Or, if of childbearing potential,

- Agree not to try to become pregnant during the study and for 6 months after
the final study drug administration

- And have a negative urine or serum pregnancy test at screening

- And, if heterosexually active, agree to consistently use highly effective*
contraception per locally accepted standards in addition to a barrier method
starting at screening and throughout the study period and for 6 months after
the final study drug administration.

- Highly effective forms of birth control include:

- Consistent and correct usage of established hormonal contraceptives
that inhibit ovulation,

- Established intrauterine device (IUD) or intrauterine system (IUS),

- Bilateral tubal occlusion,

- Vasectomy (A vasectomy is a highly effective contraception method
provided the absence of sperm has been confirmed. If not, an additional
highly effective method of contraception should be used.)

- Male is sterile due to a bilateral orchiectomy.

- Sexual abstinence is considered a highly effective method only if
defined as refraining from heterosexual activity during the entire
period of risk associated with the study drug. The reliability of
sexual abstinence needs to be evaluated in relation to the duration of
the clinical study and the preferred and usual lifestyle of the
patient.

- (*)List is not all inclusive. Prior to enrollment, the investigator is
responsible for confirming patient will utilize highly effective forms of
birth control per the requirements of the CTFG Guidance document
'Recommendations related to contraception and pregnancy testing in clinical
trials', September 2014 (and any updates thereof) during the protocol
defined period.

- Female patient must agree not to breastfeed starting at screening and throughout
the study period, and for 2 months and 1 week after the final study drug
administration.

- Female patient must not donate ova starting at screening and throughout the study
period, and for 6 months after the final study drug administration.

- Male patient and their female partners who are of childbearing potential must be using
highly effective contraception per locally accepted standards in addition to a barrier
method starting at screening and continue throughout the study period and for 4 months
and 1 week after the final study drug administration.

- Male patient must not donate sperm starting at screening and throughout the study
period and for 4 months and 1 week after the final study drug administration.

- Patient agrees not to participate in another interventional study while on treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior chemotherapy for AML or MDS-EB2, including prior treatment with hypomethylating
agents. Hydroxyurea is allowed for the control of peripheral leukemic blasts in
patients with leukocytosis (e.g., white blood cell [WBC] counts > 30 x 10^9/L)

- Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic
variant fusion genes/chromosome translocations

- Blast crisis after CML

- Known or suspected hypersensitivity to midostaurin or gilteritinib and/or any
excipients

- Patient requires treatment with concomitant drugs that are strong inducers of
cytochrome P450 (CYP) 3A

- Breast feeding at start of study treatment

- Active infection, including hepatitis B or C or HIV infection that is uncontrolled at
randomization. An infection controlled with an approved or closely monitored
antibiotic/antiviral/antifungal treatment is allowed.

- Patients with a currently active second malignancy. Patients are not considered to
have a currently active malignancy if they have completed therapy and are considered
by their physician to be at less than 30% risk of relapse within one year. However,
patients with the following history/concurrent conditions are allowed:

- Basal or squamous cell carcinoma of the skin;

- Carcinoma in situ of the cervix;

- Carcinoma in situ of the breast;

- Incidental histologic finding of prostate cancer

- Significant active cardiac disease within 6 months prior to the start of study
treatment, including:

- New York Heart Association (NYHA) Class III or IV congestive heart failure;

- Myocardial infarction;

- Unstable angina and/or stroke;

- Left ventricular ejection fraction (LVEF) < 40% by ECHO or MUGA scan obtained
within 28 days prior to the start of study treatment

- QTc interval using Fridericia's formula (QTcF) = 450 msec (average of triplicate
determinations) or other factors that increase the risk of QT prolongation or
arrhythmic events (e.g., heart failure, family history of long QT interval syndrome).
Prolonged QTc interval associated with bundle branch block or pacemaking is permitted
with written approval of the (co) Principal Investigator.

- Patient with hypokalemia and/or hypomagnesemia before registration (defined as values
below LLN) Note: electrolyte suppletion is allowed to correct LLN values before
registration.

- Dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the
ingestion or gastrointestinal absorption of orally administered drugs

- Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known
CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only
required if there is a clinical suspicion of CNS involvement by leukemia during
screening

- Immediate life-threatening, severe complications of leukemia such as uncontrolled
bleeding and/or disseminated intravascular coagulation

- Any other medical or psychological condition deemed by the Investigator to be likely
to interfere with a patient's ability to give informed consent or participate in the
study

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2033
Actual
Sample size
Target
Accrual to date
Final
777
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU-Adelaide-FLINDERS - Adelaide
Recruitment hospital [2] 0 0
AU-Adelaide-RAH - Adelaide
Recruitment hospital [3] 0 0
AU-Brisbane-PAH - Brisbane
Recruitment hospital [4] 0 0
AU-Brisbane-RBWH - Brisbane
Recruitment hospital [5] 0 0
AU-Camperdown-RPA - Camperdown
Recruitment hospital [6] 0 0
AU-Douglas-TOWNSVILLE - Douglas
Recruitment hospital [7] 0 0
AU-Geelong VIC-BARWONHEALTH - Geelong
Recruitment hospital [8] 0 0
AU-Gosford NSW-GOSFORDHOSPITAL - Gosford
Recruitment hospital [9] 0 0
AU-Hobart TAS-RHOBART - Hobart
Recruitment hospital [10] 0 0
AU-Melbourne-ALFRED - Melbourne
Recruitment hospital [11] 0 0
AU-Melbourne-AUSTIN - Melbourne
Recruitment hospital [12] 0 0
AU-Melbourne-BOXHILL - Melbourne
Recruitment hospital [13] 0 0
AU-Melbourne-MONASH - Melbourne
Recruitment hospital [14] 0 0
AU-Melbourne-RMELBOURNE - Melbourne
Recruitment hospital [15] 0 0
AU-Melbourne-SVHM - Melbourne
Recruitment hospital [16] 0 0
AU-Perth-FSH - Perth
Recruitment hospital [17] 0 0
AU-Perth-RPH - Perth
Recruitment hospital [18] 0 0
AU-Perth-SCGH - Perth
Recruitment hospital [19] 0 0
AU-Sydney-CONCORD - Sydney
Recruitment hospital [20] 0 0
AU-Sydney-NEPEAN - Sydney
Recruitment hospital [21] 0 0
AU-Sydney-RNSH - Sydney
Recruitment hospital [22] 0 0
AU-Sydney-WSAH - Sydney
Recruitment hospital [23] 0 0
St George Hospital - Sydney
Recruitment hospital [24] 0 0
AU-Waratah-CALVARYMATER - Waratah
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Douglas
Recruitment postcode(s) [5] 0 0
- Geelong
Recruitment postcode(s) [6] 0 0
- Gosford
Recruitment postcode(s) [7] 0 0
- Hobart
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment postcode(s) [10] 0 0
- Sydney
Recruitment postcode(s) [11] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
Brugge
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Haine-Saint-Paul
Country [11] 0 0
Belgium
State/province [11] 0 0
Hasselt
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Belgium
State/province [14] 0 0
Mons
Country [15] 0 0
Belgium
State/province [15] 0 0
Roeselare
Country [16] 0 0
Belgium
State/province [16] 0 0
Yvoir
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
Finland
State/province [18] 0 0
Tampere
Country [19] 0 0
France
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Amiens
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France
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Angers
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France
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Argenteuil
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France
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Bayonne
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France
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Besançon
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France
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Bobigny
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Chesnay
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Clamart
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Clermont-Ferrand
Country [28] 0 0
France
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Grenoble cedex 9
Country [29] 0 0
France
State/province [29] 0 0
Lille
Country [30] 0 0
France
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Limoges
Country [31] 0 0
France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Nice
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France
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Paris
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France
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Pessac
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France
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Poitiers
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France
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Reims
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France
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Rennes
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Rouen
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France
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Saint-Priest-en-Jarez
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Strasbourg
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Toulouse
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Tours
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Vandœuvre-lès-Nancy
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France
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Villejuif
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Germany
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Aschaffenburg
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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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Bremen
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Darmstadt
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Dortmund
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Düsseldorf
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Germany
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Essen
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Germany
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Esslingen
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Germany
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Flensburg
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Germany
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Frankfurt
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Germany
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Gießen
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Germany
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Goch
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
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Hamm
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Germany
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Hanau
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Germany
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Hannover
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Germany
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Heilbronn
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Germany
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Herne
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Germany
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Homburg
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Germany
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Kaiserslautern
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Germany
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Karlsruhe
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Germany
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Lemgo
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Germany
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Ludwigshafen
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Germany
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Lübeck
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Germany
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Lüdenscheid
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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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Meschede
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Germany
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Minden
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München
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Germany
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Offenburg
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Germany
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Oldenburg
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Germany
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Passau
Country [86] 0 0
Germany
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Regensburg
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Germany
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Saarbrücken
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Germany
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Stuttgart
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Germany
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Trier
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Germany
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Tübingen
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Germany
State/province [91] 0 0
Ulm
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Germany
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Villingen-Schwenningen
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Germany
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Wuppertal
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Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Galway
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Ireland
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Limerick
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Lithuania
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Vilnius
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Luxembourg
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Luxembourg
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Breda
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Netherlands
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Delft
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Netherlands
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Den Bosch
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Netherlands
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Den Haag
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Netherlands
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Dordrecht
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Netherlands
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Eindhoven
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Netherlands
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Enschede
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
State/province [112] 0 0
Leiden
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Netherlands
State/province [113] 0 0
Maastricht
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Netherlands
State/province [114] 0 0
Nieuwegein
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Netherlands
State/province [115] 0 0
Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Netherlands
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Zwolle
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromsø
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Norway
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Trondheim
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Lleida
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Spain
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Madrid
Country [128] 0 0
Spain
State/province [128] 0 0
Palma
Country [129] 0 0
Spain
State/province [129] 0 0
Tarragona
Country [130] 0 0
Spain
State/province [130] 0 0
Valencia
Country [131] 0 0
Sweden
State/province [131] 0 0
Lund
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Sweden
State/province [132] 0 0
Stockholm
Country [133] 0 0
Sweden
State/province [133] 0 0
Uppsala
Country [134] 0 0
Switzerland
State/province [134] 0 0
Aarau
Country [135] 0 0
Switzerland
State/province [135] 0 0
Basel
Country [136] 0 0
Switzerland
State/province [136] 0 0
Bellinzona
Country [137] 0 0
Switzerland
State/province [137] 0 0
Bern
Country [138] 0 0
Switzerland
State/province [138] 0 0
Fribourg
Country [139] 0 0
Switzerland
State/province [139] 0 0
Geneve
Country [140] 0 0
Switzerland
State/province [140] 0 0
Lausanne
Country [141] 0 0
Switzerland
State/province [141] 0 0
Luzern
Country [142] 0 0
Switzerland
State/province [142] 0 0
Saint Gallen
Country [143] 0 0
Switzerland
State/province [143] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
Stichting Hemato-Oncologie voor Volwassenen Nederland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Astellas Pharma Global Development, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in
approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of
the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free
survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a
more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has
shown promising clinical activity in AML.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04027309
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. Raaijmakers, Prof. Dr.
Address 0 0
Erasmus MC / HOVON
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries