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Search / Trial NCT05024552

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Aug 23, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for patients with acute myeloid leukemia (AML) that has the FLT3 mutation and has either come back after treatment or did not respond to previous therapies. The treatment involves two medications: Vyxeos and Gilteritinib. Initially, patients will receive these drugs together to try to achieve complete remission, which means that there are no signs of the disease. If they respond well, they can continue with additional treatment using the same medications. For those who don't go on to receive a stem cell transplant, there will be a maintenance phase with daily Gilteritinib to help keep the leukemia under control.

To participate in this trial, patients should be 65 years or older and must have a specific mutation in their leukemia. They need to be able to take oral medications and have good overall health, with certain limits on other health conditions. Patients will need to sign a consent form and be willing to follow all study procedures. It’s important to note that patients cannot be taking other investigational drugs or have certain serious health issues that could interfere with the trial. This trial is currently enrolling participants, so there is an opportunity for eligible patients to join and potentially benefit from this new treatment approach.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy
  • FLT3 testing must be confirmed at the time of disease relapse
  • Adequate organ function
  • Left ventricular ejection fraction (LVEF) ≥50%
  • Prior anthracycline exposure ≤368 mg/m2 daunorubicin (or equivalent)
  • 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 who have relapsed after and allogeneic stem cell transplant must have controlled grade ≤2 GVHD. Immunosuppression with tacrolimus or sirolimus is allowed at stable or tapering doses.
  • Exclusion Criteria:
  • Patients may not be receiving any other investigational agents
  • Patients with documented central nervous system involvement of AML
  • Progression of AML while on prior gilteritinib therapy
  • 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 at the time study treatment begins. Use of hydroxyurea to maintain WBC \<50,000 is allowed up to the time that study treatment begins
  • 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
  • Grade ≥3 acute or chronic graft versus host disease after allogeneic stem cell transplant. No steroids for GVHD are allowed.

About H. Lee Moffitt Cancer Center And Research Institute

H. Lee Moffitt Cancer Center and Research Institute is a leading institution dedicated to cancer research, treatment, and education, recognized for its commitment to advancing cancer care through innovative clinical trials and groundbreaking research. As a National Cancer Institute-designated Comprehensive Cancer Center, Moffitt integrates cutting-edge science with patient-centered care, offering a multidisciplinary approach to cancer treatment. The center is at the forefront of developing novel therapies and improving outcomes for patients, emphasizing collaboration between researchers and clinicians to translate scientific discoveries into effective treatments. Through its extensive clinical trial programs, Moffitt aims to enhance the understanding of cancer biology and provide patients with access to the latest therapies and interventions.

Locations

Tampa, Florida, United States

Tampa, Florida, United States

Patients applied

0 patients applied

Trial Officials

Onyee Chan, MD

Principal Investigator

Moffitt Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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