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Tyrosine Kinase Inhibitor

Crenolanib vs Midostaurin for Acute Myeloid Leukemia

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights

Study 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.Check my eligibility
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).See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Composite complete remission rate
Duration of response
Overall Survival
+1 more

Side effects data

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

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
~76 spots leftby Jun 2025
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