Clinical Trial TitlePhase III randomized study of crenolanib versus midostaurin administered following induction chemotherapy and consolidation therapy in newly diagnosed subjects with FLT3 mutated acute myeloid leukemia.
National Clinical Trial Number:NCT03258931
Clinical Trial Protocol Description:
During the treatment period, newly diagnosed acute myeloid leukemia subjects with FLT3 mutation will receive cytarabine and daunorubicin as induction chemotherapy, followed by crenolanib for subjects randomized to arm A (the crenolanib treatment arm) or midostaurin for subjects randomized to arm B (the control arm).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification.
- Are between 18 and 60 years of age.
- Have adequate hepatic function within 48 hours prior to induction chemotherapy, defined as:
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN
- Serum alanine aminotransferase (ALT) ≤ 3.0 x ULN
- Have adequate renal functions within 48 hours prior to induction chemotherapy, defined as:
- Serum creatinine ≤ 1.5x ULN or glomerular filtration rate > 50 mL/min
- Have an ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3.
- Are eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy.
All potential subjects for the trial will undergo a pre-screening process.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.