Status:
COMPLETED
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Primary Objective: • 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 Da...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03298984
Start Date
September 25 2017
End Date
March 20 2020
Last Update
November 15 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
2
Columbia University
New York, New York, United States, 10032
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599