Hershey, PANCT05101551Now EnrollingIRB Ready

Acute Myeloid Leukemia Clinical Trial in Hershey, PA

Access cutting-edge acute myeloid leukemia treatment through this clinical trial at a research site in Hershey. Study-provided care at no cost to qualified participants.

Sponsored by Norman J. Lacayo

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Expert Care in Hershey

Access acute myeloid leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia treatment provided free

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Check if you qualify for this acute myeloid leukemia clinical trial in Hershey, PA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Hershey

    Convenient for PA 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 Hershey site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia Study in Hershey

This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study. This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.

Sponsor: Norman J. Lacayo

Who Can Participate

Inclusion Criteria

Aged ≤ 21 years.
Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified as either refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or relapsed, and further defined as any one of the criteria below:
Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of the following:
Karyotypic abnormality with at least 1 metaphase similar or identical to diagnosis
FISH abnormality identical to one present at diagnosis
PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
Rising MRD \> 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by Hematologics Inc.
If an adequate bone marrow sample is not obtained, subjects may be enrolled if there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral blood
\> 60 days has passed since hematopoietic stem cell transplant.
Patients who have undergone previous allogeneic stem cell transplantation who are otherwise eligible must also be without evidence of any active graft versus host disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg) or equivalent other steroid dose is allowable.
A minimum of 14 days has passed since completion of myelosuppressive therapy or gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
A minimum of 24 hours has elapsed since the patient has completed any low-dose or non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100 mg/m2).
Lansky (subjects ≤ 16 years old) or Karnofsky (subjects \> 16 years old) score ≥ 50.
WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea or low-dose cytarabine (up to 100 mg/m2/dose)
Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
AST/ALT ≤ 5 x ULN for age
Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
Estimated serum creatinine ≥ 60 mL/min/1.73m2

Exclusion Criteria

Patients receiving or planning to receive ANY concurrent cancer therapy, including chemotherapy, radiation therapy, immunotherapy or biologic therapy.
Patients with down syndrome.
Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML).
Patients with Bone Marrow Failure Syndrome.
Pregnant subjects or those unwilling to use an effective method of birth control.
Female subjects with infants who do NOT agree to abstain from breastfeeding.
Inability or unwillingness of legal guardian/representative to give written informed consent.
Patients with uncontrolled systemic fungal, bacterial, viral or other infection.

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 Hershey?

Yes, this clinical trial (NCT05101551) has an active research site in Hershey, PA 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 Hershey, PA

If you're searching for acute myeloid leukemia treatment options in Hershey, PA, this clinical trial (NCT05101551) 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 Hershey research site is actively enrolling participants for this 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.

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