Acute Myeloid Leukemia Clinical Trial
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
• To determine the safety and tolerability including the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML
To observe patients for any evidence of antileukemic activity of alvocidib plus 7+3 using the 2017 ELN response criteria
To establish the Recommended Phase 2 Dose (RP2D) for future studies with alvocidib in combination with 7+3
• To assess levels of minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry [MPFC] and next generation sequencing [NGS] and evaluate other potential biomarkers including, but not limited to, MCL-1 dependency.
To be eligible for participation in the study, patients must meet all of the following inclusion criteria:
Be between the ages of ≥18 and ≤65 years
Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria with ≥20% bone marrow blasts based on histology or flow cytometry
Be newly diagnosed and previously untreated
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
Have a serum creatinine level ≤1.8 mg/dL
Have an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤5 times upper limit of normal (ULN)
Have a total bilirubin level ≤2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Have a left ventricular ejection fraction (LVEF) >45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of study drug.
Be able to comply with the requirements of the entire study.
Provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
Patients meeting any one of these exclusion criteria will be prohibited from participating in this study.
Received any previous treatment for AML
Diagnosed with APL-M3 or CBF-AML
Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting Induction therapy.
Received >200 mg/m2 equivalents of daunorubicin
Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #3 above)
Have active central nervous system (CNS) leukemia
Have evidence of uncontrolled disseminated intravascular coagulation
Have an active, uncontrolled infection
Have other life-threatening illness
Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
Are pregnant and/or nursing
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 3 Locations for this study
Baltimore Maryland, 21287, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27599, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.