← Back to Search

Tyrosine Kinase Inhibitor

Crenolanib vs Midostaurin for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Research Sponsored by Arog Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Must not have
Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Severe liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether crenolanib or midostaurin are more effective when administered following induction chemotherapy, consolidation chemotherapy, and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation.

Who is the study for?
This trial is for adults aged 18-60 with newly diagnosed Acute Myeloid Leukemia (AML) that has a specific mutation called FLT3. Participants must have good liver and kidney function, not be too sick to undergo intensive chemotherapy, and can't have had previous cancer treatments except hydroxyurea or leukapheresis.
What is being tested?
The study compares Crenolanib versus Midostaurin effectiveness when given after standard AML treatment: induction chemo, consolidation therapy, and possibly bone marrow transplant. About 510 patients will be randomly assigned to either the Crenolanib group (arm A) or the Midostaurin group (arm B).
What are the potential side effects?
Crenolanib and Midostaurin may cause side effects like nausea, vomiting, diarrhea, liver problems, bleeding issues due to low blood counts. The chemotherapy drugs used can also lead to hair loss, mouth sores, increased infection risk due to weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has FLT3-ITD or D835 mutations.
Select...
I am eligible for a specific intensive chemotherapy treatment.
Select...
I have been diagnosed with a new case of AML as per WHO 2016 guidelines.
Select...
I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active hepatitis B or C infection.
Select...
I have severe liver disease.
Select...
I have active leukemia in my brain or spinal cord.
Select...
I do not have any active infections.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 1 & 2 trial • 16 Patients • NCT02626338
69%
Diarrhoea
63%
Nausea
56%
Febrile neutropenia
44%
Constipation
38%
Fatigue
31%
Oedema peripheral
31%
Hypokalaemia
31%
Abdominal pain
31%
Pyrexia
31%
Hypertension
31%
Anaemia
31%
Hypotension
25%
Vomiting
25%
Hypomagnesaemia
25%
Sinus tachycardia
25%
Decreased appetite
25%
Headache
25%
Cough
19%
Oedema
19%
Thrombocytopenia
19%
Hypoxia
19%
Chills
19%
Epistaxis
19%
Abdominal distension
19%
Dizziness
19%
Insomnia
13%
Vision blurred
13%
Rash
13%
Upper gastrointestinal haemorrhage
13%
Rash maculo-papular
13%
Oral disorder
13%
Dyspepsia
13%
Neck pain
13%
Upper gastrointestinal hemorrhage
13%
Clostridium difficile colitis
13%
Dyspnoea
13%
Gastric haemorrhage
13%
Cellulitis
13%
Pneumonia bacterial
13%
Leukopenia
6%
Hyperlipidaemia
6%
Toothache
6%
Blood chloride increased
6%
Neuropathy peripheral
6%
Pollakiuria
6%
Mental status change
6%
Lacrimation increased
6%
Non-cardiac chest pain
6%
Conjunctival haemorrhage
6%
Anorectal discomfort
6%
Hypophosphataemia
6%
Viral upper respiratory tract infection
6%
Hypocalcaemia
6%
Sleep apnoea syndrome
6%
Atrial fibrillation
6%
Blood alkaline phosphatase increased
6%
Dermatitis acneiform
6%
Acute kidney injury
6%
Weight increased
6%
Bone pain
6%
Ileus
6%
Acute myocardial infarction
6%
Small intestinal haemorrhage
6%
Presyncope
6%
Eye irritation
6%
Anal skin tags
6%
Dry mouth
6%
Rhinitis allergic
6%
Colitis
6%
Hyponatraemia
6%
Vaginal haemorrhage
6%
Pancytopenia
6%
Tongue blistering
6%
Haemorrhoids
6%
Neutropenia
6%
Hypoalbuminaemia
6%
Hyperbilirubinaemia
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Rash erythematous
6%
Face oedema
6%
Pleural effusion
6%
Bacteraemia
6%
Erythema
6%
Pneumonitis
6%
Mucosal inflammation
6%
Nasal congestion
6%
Anal incontinence
6%
Fall
6%
Pericardial effusion
6%
Syncope
6%
Eye swelling
6%
Graft versus host disease in gastrointestinal tract
6%
Graft versus host disease in skin
6%
Hypogammaglobulinaemia
6%
Escherichia bacteraemia
6%
Oral herpes
6%
Blood bilirubin increased
6%
Hyperphosphataemia
6%
Pain in extremity
6%
Peripheral sensory neuropathy
6%
Subarachnoid haemorrhage
6%
Confusional state
6%
Mental status changes
6%
Dysuria
6%
Urinary incontinence
6%
Alopecia
6%
Drug eruption
6%
Ecchymosis
6%
Haemorrhoidal haemorrhage
6%
Melaena
6%
Streptococcal bacteraemia
6%
Blood urea increased
6%
Lymphocyte count decreased
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
White blood cell count decreased
6%
Gout
6%
Hyperglycaemia
6%
Soft tissue swelling
6%
Seborrhoeic keratosis
6%
Petechiae
6%
Rash papular
6%
Proctalgia
6%
Proctitis
6%
Pneumonia fungal
6%
Back pain
6%
Anxiety
6%
Urinary retention
6%
Night sweats
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients
Arm A: HAM Chemotherapy
Arm B: FLAG-Ida Chemotherapy
Arm C: MEC Chemotherapy

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CrenolanibExperimental Treatment3 Interventions
Crenolanib following salvage chemotherapy
Group II: MidostaurinActive Control3 Interventions
Midostaurin following salvage chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crenolanib
Not yet FDA approved
Cytarabine
FDA approved

Find a Location

Who is running the clinical trial?

Arog Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
816 Total Patients Enrolled

Media Library

Crenolanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03258931 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Crenolanib, Midostaurin
Acute Myeloid Leukemia Clinical Trial 2023: Crenolanib Highlights & Side Effects. Trial Name: NCT03258931 — Phase 3
Crenolanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03258931 — Phase 3
~70 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top