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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
Adequate hepatic function
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 below
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My AML did not respond or has returned after initial treatments.
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My liver is working well.
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I have been diagnosed with AML according to WHO standards.
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My kidney function is normal.
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I am capable of limited self-care.
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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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Complete remission rate (CR)
MRD negative complete remission rate
Overall Survival
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 16 Patients • NCT02626338
100%
Proctalgia
100%
Back pain
100%
Pneumonia bacterial
100%
Night sweats
100%
Anaemia
100%
Leukopenia
100%
Oedema peripheral
100%
Decreased appetite
100%
Dizziness
100%
Haemorrhoids
100%
Thrombocytopenia
100%
Gastric haemorrhage
100%
Proctitis
100%
Pneumonia fungal
100%
Urinary retention
100%
Abdominal pain
100%
Sinus tachycardia
100%
Headache
100%
Hypertension
100%
Nausea
100%
Insomnia
100%
Diarrhoea
100%
Hypomagnesaemia
100%
Anxiety
100%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm C: MEC Chemotherapy
All Patients
Arm A: HAM Chemotherapy
Arm B: FLAG-Ida 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

Crenolanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03250338 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Crenolanib, Placebo
Acute Myeloid Leukemia Clinical Trial 2023: Crenolanib Highlights & Side Effects. Trial Name: NCT03250338 — Phase 3
Crenolanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03250338 — Phase 3

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
~26 spots leftby Oct 2024