Newly Diagnosed FLT3 Mutated AMLPhase 3NCT03258931
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
A Phase 3 study testing Crenolanib, Midostaurin and Cytarabine in people with Newly Diagnosed FLT3 Mutated AML, run by Arog Pharmaceuticals, Inc. at 31 sites in United States.
Trial summary
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Newly Diagnosed FLT3 Mutated AML
- What is being tested?
- Crenolanib, Midostaurin and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 31 sitesUnited States
- Study dates
- 15 Aug 2018to 6 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
- Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
- Age ≥ 18 years and ≤ 60 years
- Adequate hepatic function within 48 hours prior to induction chemotherapy
- Adequate renal functions within 48 hours prior to induction chemotherapy
- ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
- Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Who cannot join
- Acute promyelocytic leukemia (APL)
- Known clinically active central nervous system (CNS) leukemia
- Severe liver disease
- Active infections
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known infection with human immunodeficiency virus (HIV)
- Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deacnss Medical Center Oncology
Boston, Massachusetts, 02215
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02215
Roswell Park
Buffalo, New York, 14263
The UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
University of Virginia Health System
Charlottesville, Virginia, 22908
Rush Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
Indiana University
Indianapolis, Indiana, 46206-5149
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas
Kansas City, Kansas, 66160
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale Cancer Center
New Haven, Connecticut, 06510
New York University
New York, New York, 10016
Mount Sinai
New York, New York, 10029-6574
Columbia University
New York, New York, 10032
Cornell University
New York, New York, 10065
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Rochester Medical Center
New York, New York, 14642
Oregon Health and Science University
Portland, Oregon, 97239
US Davis Health
Sacramento, California, 95817
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest Baptist Health, Section on Hematology & Oncology
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
- Conditions
- Newly Diagnosed FLT3 Mutated AML
- Being tested
- Crenolanib, Midostaurin, Cytarabine, Duanorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenolanibDrug
Also called Crenolanib besylate
Crenolanib will be administered orally
MidostaurinDrug
Midostaurin will be administered orally
CytarabineDrug
100 mg/m² IV continuous infusion over 24 hours
DuanorubicinDrug
90 mg/m2 IV
| Study group | Role | What they receive |
|---|---|---|
| Crenolanib | Experimental | Crenolanib following salvage chemotherapy Receives: Drug: Crenolanib; Drug: Cytarabine; Drug: Duanorubicin |
| Midostaurin | Active comparator | Midostaurin following salvage chemotherapy Receives: Drug: Midostaurin; Drug: Cytarabine; Drug: Duanorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Measured: 5 years
Secondary outcomes (4)
Overall Survival
Measured: 7 years
Relapse free survival
Measured: 5 years
Composite complete remission rate
Measured: 5 years
Duration of response
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start15 Aug 2018
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed FLT3 Mutated AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arog Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258931
- Sponsor's protocol ID
- ARO-021
- Status last verified
- Apr 2022
- First submitted
- 21 Aug 2017
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03258931
- Acronym / sponsor ID
- ARO-021
- Conditions
- Newly Diagnosed FLT3 Mutated AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Arog Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crenolanib | Experimental | Drug: Crenolanib, Drug: Cytarabine, Drug: DuanorubicinCrenolanib following salvage chemotherapy |
| Midostaurin | Active comparator | Drug: Midostaurin, Drug: Cytarabine, Drug: DuanorubicinMidostaurin following salvage chemotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
- Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
- Age ≥ 18 years and ≤ 60 years
- Adequate hepatic function within 48 hours prior to induction chemotherapy
- Adequate renal functions within 48 hours prior to induction chemotherapy
Key exclusion criteria (7 listed)
- Acute promyelocytic leukemia (APL)
- Known clinically active central nervous system (CNS) leukemia
- Severe liver disease
- Active infections
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrenolanibAlso: Crenolanib besylateCrenolanib will be administered orally | Drug | Crenolanib |
| MidostaurinMidostaurin will be administered orally | Drug | Midostaurin |
| Cytarabine100 mg/m² IV continuous infusion over 24 hours | Drug | Crenolanib, Midostaurin |
| Duanorubicin90 mg/m2 IV | Drug | Crenolanib, Midostaurin |
Primary outcome
Event-free survival (EFS)
Time frame: 5 years
4 secondary outcomes
Overall Survival
Time frame: 7 years
Relapse free survival
Time frame: 5 years
Composite complete remission rate
Time frame: 5 years
Duration of response
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 1/2
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia
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ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
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RecruitingPhase 1
A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease
Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement
Active, not recruitingPhase 2
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crenolanib, Midostaurin and Cytarabine in people with Newly Diagnosed FLT3 Mutated AML, run by Arog Pharmaceuticals, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.