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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
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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.
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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%
Hypertension
31%
Abdominal pain
31%
Anaemia
31%
Pyrexia
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%
Gastric haemorrhage
13%
Upper gastrointestinal hemorrhage
13%
Oral disorder
13%
Neck pain
13%
Rash
13%
Vision blurred
13%
Cellulitis
13%
Pneumonia bacterial
13%
Upper gastrointestinal haemorrhage
13%
Clostridium difficile colitis
13%
Dyspepsia
13%
Rash maculo-papular
13%
Leukopenia
13%
Dyspnoea
6%
Anal incontinence
6%
Bacteraemia
6%
Fall
6%
Melaena
6%
Peripheral sensory neuropathy
6%
Vaginal haemorrhage
6%
Pericardial effusion
6%
Subarachnoid haemorrhage
6%
Confusional state
6%
Toothache
6%
Lymphocyte count decreased
6%
Neutrophil count decreased
6%
Acute kidney injury
6%
Dermatitis acneiform
6%
Lacrimation increased
6%
Pain in extremity
6%
Graft versus host disease in gastrointestinal tract
6%
Graft versus host disease in skin
6%
Hypogammaglobulinaemia
6%
Sleep apnoea syndrome
6%
Alopecia
6%
Erythema
6%
Neutropenia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Soft tissue swelling
6%
Seborrhoeic keratosis
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Petechiae
6%
Rash papular
6%
Pneumonia fungal
6%
Dysuria
6%
Ecchymosis
6%
Pleural effusion
6%
Colitis
6%
Dry mouth
6%
Hyperphosphataemia
6%
Haemorrhoidal haemorrhage
6%
Blood creatinine increased
6%
Anxiety
6%
Presyncope
6%
Gout
6%
Blood urea increased
6%
Small intestinal haemorrhage
6%
Conjunctival haemorrhage
6%
Proctalgia
6%
Blood alkaline phosphatase increased
6%
Hyperglycaemia
6%
Anorectal discomfort
6%
Urinary retention
6%
Night sweats
6%
Weight increased
6%
Mental status changes
6%
Acute myocardial infarction
6%
Viral upper respiratory tract infection
6%
Mental status change
6%
Escherichia bacteraemia
6%
Oral herpes
6%
Back pain
6%
Bone pain
6%
Haemorrhoids
6%
Syncope
6%
Rash erythematous
6%
Pollakiuria
6%
Anal skin tags
6%
Hyperlipidaemia
6%
Drug eruption
6%
White blood cell count decreased
6%
Eye irritation
6%
Ileus
6%
Pancytopenia
6%
Tongue blistering
6%
Streptococcal bacteraemia
6%
Aspartate aminotransferase increased
6%
Platelet count decreased
6%
Hypoalbuminaemia
6%
Nasal congestion
6%
Proctitis
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being taken on as part of this clinical trial?

"To carry out this clinical trial, Arog Pharmaceuticals, Inc. needs to enroll 510 patients that fit the bill in terms of inclusion criteria. The trial will be conducted out of different sites including Rutgers Cancer Institute of New jersey in New Brunswick, New Jersey and City of Hope National Medical Center in Duarte, Connecticut."

Answered by AI

Can you provide some context for Crenolanib's clinical trial history?

"There are currently 257 trials for Crenolanib with 62 of them in Phase 3. Many of these trials are hosted in New york City, but there are 10116 clinical trial locations in total."

Answered by AI

Has the FDA sanctioned crenolanib for public use?

"Crenolanib's safety is supported by prior clinical data, and thus it received a score of 3."

Answered by AI

In how many medical facilities is this trial taking place?

"Currently, this clinical trial is being conducted at 31 sites. These locations include New Brunswick, Duarte, New Haven and other cities. If you enroll in the trial, it is best to select the location nearest you to avoid any unnecessary travel."

Answered by AI

What are Crenolanib's usual medical applications?

"Crenolanib has been approved by the FDA to treat neoplasms of mast cells, as well as conditions like non-hodgkin's lymphoma, systemic mastocytosis, and leptomeningeal metastases."

Answered by AI

If a patient is under 55 years old, can they participate in this particular research project?

"The age requirements to participate in this particular trial are between 18 to 60 years old. However, there are other 78 clinical trials that allow people under 18 and 167 trials for people over 65."

Answered by AI

How do I qualify to participate in this research project?

"Up to 510 individuals who have recently been diagnosed with flt3 mutated aml and who are between 18-60 years old may be enrolled in this clinical trial. Most importantly, applicants must meet the following two requirements: ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3 and age ≥ 18 years and ≤ 60 years."

Answered by AI

Are we looking for more participants at this time?

"Yes, the trial is currently active and recruiting patients at the 31 locations that are participating. The trial was first posted on 2018-08-15 and was last edited on 2020-05-21. The goal is to enroll 510 patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
2018. "Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03258931.
~76 spots leftby Apr 2025
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