Tampa, FLNCT05024552Now EnrollingIRB Ready

Acute Myeloid Leukemia With FLT3/ITD Mutation Clinical Trial in Tampa, FL

Access cutting-edge acute myeloid leukemia with flt3/itd mutation treatment through this clinical trial at a research site in Tampa. Study-provided care at no cost to qualified participants.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute

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Expert Care in Tampa

Access acute myeloid leukemia with flt3/itd mutation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia with flt3/itd mutation treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Tampa

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Tampa site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia With FLT3/ITD Mutation Study in Tampa

This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT05024552) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia With FLT3/ITD Mutation Treatment Options in Tampa, FL

If you're searching for acute myeloid leukemia with flt3/itd mutation treatment options in Tampa, FL, this clinical trial (NCT05024552) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia with flt3/itd mutation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia with flt3/itd mutation clinical trials near you to find additional studies recruiting in your area.

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