Is NCT05558124 recruiting in Tampa, FL?

Yes, NCT05558124 is currently recruiting participants at its Tampa, FL location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Tampa?

To join this clinical trial in Tampa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tampa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Tampa, FL

About This Acute Myeloid Leukemia Study in Tampa

The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.

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

Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as defined by ELN 2017 criteria

For females of child-bearing potential: use of highly effective contraception upon enrollment and during study participation and for an additional 6 months after the end of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearing potential is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months

The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as defined above must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment.

For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry

ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by the treating physician

Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.

Prior hypomethylating agents (HMA) therapy including azacitidine or decitabine when used for non-AML diagnoses is allowed. Most recent dose must have been ≥14 days prior to day 1 of study treatment.

Participants must have acceptable organ function

Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram.

Hydroxyurea is allowed for cytoreduction until day 1 of study treatment

Exclusion Criteria

Prior treatment of AML except hydroxyurea and/or leukapheresis

Participants with acute promyelocytic leukemia (APL).

Known current and clinically active central nervous system (CNS) leukemia.

Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease.

Participants with known active infection with hepatitis B or hepatitis C virus

Known allergic reactions to components of the CPX-351 (cytarabine or daunorubicin) or Gemtuzumab ozogamicin.

Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent).

Hemodynamically unstable (subjects requiring vasopressor support will not be eligible).

Treatment with another investigational drug within 14 days.

Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.

Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures.

Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results.

Female subject who is pregnant or breastfeeding.

Any patient with a known FLT3 ITD or FLT3 TKD mutation

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 (NCT05558124) 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 Treatment Options in Tampa, FL

If you're searching for acute myeloid leukemia treatment options in Tampa, FL, this clinical trial (NCT05558124) 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 phase 1 clinical trial. You'll receive care from experienced acute myeloid leukemia 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 clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Tampa, FL

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