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Clinical Trial 20752

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05024552

Phase: Phase I
Principal Investigator: Sweet, Kendra

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia

Summary

This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia.

Objective

Primary Objective: To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of gilteritinib when given in combination with vyxeos Secondary Objectives: 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

Treatments

Therapies

Therapy (NOS)

Medications

Cytarabine (Cytosine Arabinoside); Daunomycin (daunorubicin); daunorubicin (); gilteritinib ()

Inclusion 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 Coopertive 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

Other criteria may apply

Exclusion Criteria

Exclusion Criteria:

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

Other exclusions may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.