A Study of Experimental Medicine Crenolanib vs Midostaurin For Newly Diagnosed Acute Myeloid Leukemia

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Age: 18 to 60 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia, Leukemia
Type: Drug study, Phase 3
Target:
16 Participants
Investigator:
Description
This study will compare the effectivenses of an investigational drug called crenolanib with midostaurin (RYDAPT®). It will be used in newly diagnosed acute myeloid leukemia patients with FLT3 mutations.

“Acute myeloid leukemia” (AML) is a cancer of the white blood cells. “Mutations” occur when the genetic code is changed or damaged. “FLT3” is an abbreviation for the part of genetic code, also called a “gene” called “FMS-like Tyrosine Kinase 3”. The gene for FLT3 is changed from normal (mutated) in the leukemia cells of about 1 in 3 patients with acute myeloid leukemia.

Crenolanib is an investigational product, which means that it has not yet been approved by the FDA. Crenolanib is a pill that is taken by mouth three times a day. Crenolanib is a type of drug known as a Tyrosine Kinase Inhibitor (TKI). TKI is a pharmaceutical drug that inhibits tyrosine kinases, that is activated in cancer. This study is researching the potential of experimental crenolanib compared with midostaurin (RYDAPT®).
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
  • Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
  • Age ≥ 18 years and ≤ 60 years
  • Adequate hepatic function within 48 hours prior to induction chemotherapy
  • Adequate renal functions within 48 hours prior to induction chemotherapy
  • ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
  • Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified

Exclusion criteria:

  • Acute promyelocytic leukemia (APL)
  • Known clinically active central nervous system (CNS) leukemia
  • Severe liver disease
  • Active infections
  • Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Known infection with human immunodeficiency virus (HIV)
  • Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The estimated average time that a participant will receive study drug or midostaurin (RYDAPT®) on this study is about 12-18 months.
Recruitment period
From Jan. 26, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Newly Diagnosed FLT3 Mutated AML

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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