A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia.
Primary Objective: To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of gilteritinib when given in combination with vyxeos
1) To determine the complete remission and complete remission with incomplete blood count recovery rate
2) To determine the event free survival (EFS)
3) To determine the overall survival (OS)
4) To determine the rate of MRD eradication using FLT3 PCR with a sensitivity of 10-5 mutant/wild type variant read frequency
Ability to take oral medication and willingness to adhere to the medication regimen
For females of reproductive potential: use of highly effective contraception including double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices and tubal ligation.
For females of reproductive potential: negative serum or urine pregnancy test with a sensitivity of at least 50mIU/mL within 10 days and again within 24 hours of beginning study treatment
For males of reproductive potential: use of condoms
Breastfeeding mothers must agree to discontinue nursing
Patients may not be receiving any other investigational agents
Patients with documented central nervous system involvement of AML
Any prior use of gilteritinib
Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications
Major surgery within two weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than two weeks prior
WBC count 50,000 or more at the time study treatment begins. Use of hydroxyurea to maintain WBC > Predicted inability to tolerate standard induction chemotherapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
No other malignancies in addition to AML that are currently requiring treatment with the exception of: 1) basal cell or squamous cell carcinoma or the skin; 2) carcinoma in situ of the cervix or breast; 3) a history of breast cancer that is currently being managed with adjuvant endocrine therapy
Patients may not have undergone an allogeneic stem cell transplant at any time in the past
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