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Tyrosine Kinase Inhibitor
Crenolanib + Chemotherapy for Acute Myeloid Leukemia
Phase 3
Recruiting
Led By Eunice Wang, MD
Research Sponsored by Arog Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain type of leukemia who have not responded to other treatments.
Who is the study for?
This trial is for adults aged 18-75 with relapsed or refractory Acute Myeloid Leukemia (AML) and a specific mutation called FLT3. Participants must have tried at least one other AML treatment, have good liver and kidney function, and be able to perform daily activities with some limitations.Check my eligibility
What is being tested?
The study tests the effectiveness of Crenolanib combined with chemotherapy versus chemotherapy alone in patients whose AML has returned or resisted treatment. It's randomized, meaning participants are put into groups by chance, double-blind so neither doctors nor patients know who gets what treatment, and placebo-controlled.See study design
What are the potential side effects?
Crenolanib may cause side effects like nausea, vomiting, diarrhea, increased risk of infections due to low blood cell counts, liver problems, fatigue and potential heart issues. Chemotherapy can also lead to hair loss, mouth sores and an increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML did not respond or has returned after initial treatments.
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I have been diagnosed with AML according to WHO standards.
Select...
I am capable of limited self-care.
Select...
I am between 18 and 75 years old.
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My cancer has a specific genetic mutation (FLT3-ITD or D835).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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
Complete remission rate (CR)
MRD negative complete remission rate
Overall Survival
+1 moreSide effects data
From 2018 Phase 1 & 2 trial • 16 Patients • NCT0262633869%
Diarrhoea
63%
Nausea
56%
Febrile neutropenia
44%
Constipation
38%
Fatigue
31%
Abdominal pain
31%
Pyrexia
31%
Anaemia
31%
Hypotension
31%
Hypertension
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%
Oral disorder
13%
Upper gastrointestinal hemorrhage
13%
Neck pain
13%
Cellulitis
13%
Vision blurred
13%
Rash maculo-papular
13%
Upper gastrointestinal haemorrhage
13%
Clostridium difficile colitis
13%
Pneumonia bacterial
13%
Rash
13%
Dyspepsia
13%
Dyspnoea
13%
Leukopenia
6%
Presyncope
6%
Dysuria
6%
Melaena
6%
Toothache
6%
Blood creatinine increased
6%
Gout
6%
Soft tissue swelling
6%
Subarachnoid haemorrhage
6%
Anorectal discomfort
6%
Dermatitis acneiform
6%
Hypogammaglobulinaemia
6%
Bacteraemia
6%
Fall
6%
Drug eruption
6%
Ecchymosis
6%
Rash erythematous
6%
Anal incontinence
6%
Small intestinal haemorrhage
6%
Blood urea increased
6%
Lymphocyte count decreased
6%
Vaginal haemorrhage
6%
Rash papular
6%
Back pain
6%
Confusional state
6%
Neutropenia
6%
Sleep apnoea syndrome
6%
Alopecia
6%
Hyponatraemia
6%
Neuropathy peripheral
6%
Nasal congestion
6%
Lacrimation increased
6%
Graft versus host disease in skin
6%
Petechiae
6%
Haemorrhoids
6%
Pneumonia fungal
6%
Seborrhoeic keratosis
6%
Dry mouth
6%
Hyperphosphataemia
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%
Graft versus host disease in gastrointestinal tract
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%
Mental status change
6%
Pericardial effusion
6%
Viral upper respiratory tract infection
6%
Haemorrhoidal haemorrhage
6%
Escherichia bacteraemia
6%
Oral herpes
6%
Bone pain
6%
Syncope
6%
Pollakiuria
6%
Peripheral sensory neuropathy
6%
Anal skin tags
6%
Hyperlipidaemia
6%
Pain in extremity
6%
Ileus
6%
Pancytopenia
6%
Tongue blistering
6%
Streptococcal bacteraemia
6%
Aspartate aminotransferase increased
6%
Hypoalbuminaemia
6%
Pneumonitis
6%
Platelet count decreased
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
Placebo Group
Group I: CrenolanibExperimental Treatment6 Interventions
Crenolanib following salvage chemotherapy
Group II: PlaceboPlacebo Group6 Interventions
Placebo following salvage chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crenolanib
Not yet FDA approved
Fludarabine
FDA approved
Idarubicin
FDA approved
Filgrastim
FDA approved
Mitoxantrone
FDA approved
Cytarabine
FDA approved
Find a Location
Who is running the clinical trial?
Arog Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
1,004 Total Patients Enrolled
Eunice Wang, MDPrincipal InvestigatorRoswell Park Cancer Institute, Buffalo, New York, United States, 14263
4 Previous Clinical Trials
133 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver disease.I have never been treated with crenolanib or been in a crenolanib study.My AML did not respond or has returned after initial treatments.My liver is working well.I have been diagnosed with AML according to WHO standards.My kidney function is normal.I have active leukemia in my brain or spinal cord.I have an active hepatitis B or C infection.I am capable of limited self-care.I haven't had leukemia treatment in the last 14 days, except for hydroxyurea.I am between 18 and 75 years old.My cancer has a specific genetic mutation (FLT3-ITD or D835).
Research Study Groups:
This trial has the following groups:- Group 1: Crenolanib
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the findings of this Crenolanib study unique, or has this drug been researched before?
"At this time, there are 715 ongoing clinical trials researching Crenolanib with 99 in Phase 3. A notable amount of these clinical trials for Crenolanib are based in Saint Louis, Missouri, but there are15465 locations operating clinical trials for Crenolanib globally."
Answered by AI
For what purpose is Crenolanib typically prescribed?
"Crenolanib is most often prescribed as a lymphoma treatment, but it can also be used to manage multiple sclerosis, infection, and help patients recover from bone marrow transplantation."
Answered by AI
Has Crenolanib been given the green light by the FDA?
"Crenolanib has received a 3 for safety from our team at Power. This is due to the fact that it is a Phase 3 trial, thus having both some evidence of efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
Is this research project taking place in more than one hospital in this state?
"To limit participant burden, the10 sites for this clinical trial are located in or near major cities including Detroit, Winston-Salem and Chicago."
Answered by AI
Are there any active vacancies in this research program?
"This medical trial is currently recruiting patients, as noted on the clinicaltrials.gov website. The trial was first posted on June 5, 2018 and was last updated on April 28, 2021."
Answered by AI
Are there any conditions which would disqualify a patient from participating in this trial?
"Researchers are looking for 322 individuals with myeloid leukemia that fall between 18-75 years old. The most pertinent inclusion criteria are that patients have an ECOG performance status of 3 or less and are of age."
Answered by AI
Will elderly individuals be included in this research?
"Those who meet the age requirements of 18-75 years old are able to participate in this clinical trial."
Answered by AI
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