Alvocidib Biomarker-driven Phase 2 AML Study

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow.

Key facts

Study ID

NCT02520011

Run by

Sumitomo Pharma America, Inc.

People needed

104

Starts

2016-03-14

Expected to finish

2020-02-12

Last updated by the study team

2023-11-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be between the ages of ≥18 and ≤65 years
• Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of >5% blasts based on histology or flow cytometry
• Be in first relapse (within 24 months of CR) or have failed induction therapy* (no CR or CRi after treatment with an intensive regimen (eg, anthracycline/cytarabine ± etoposide, gemtuzumab ozogamicin, or cladribine).
• Induction therapy may involve 1 or 2 cycles of the same regimen. Efficacy assessment of induction therapy must be >21 days from the start of the previous induction cycle.
• Demonstrate MCL-1 dependence of ≥30% by mitochondrial profiling in bone marrow.
• 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)/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 during and for at least 6 months after completion of study therapy.
• Be able to comply with the requirements of the entire study.
• Provide written informed consent prior to any study related procedure.

You may not qualify if…

• Received more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).
• Received any previous treatment with alvocidib or any other CDK inhibitor
• Received a hematopoietic stem cell transplant within the previous 2 months
• Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days
• Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.
• Received >360 mg/m2 equivalents of daunorubicin
• Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #5 above)
• Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.
• Diagnosed with acute promyelocytic leukemia (APL, M3)
• 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
• Have received any live vaccine within 14 days prior to first study drug administration.

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• University of California San Diego UCSD — San Diego, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Sidney Kimmel Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Morristown Cancer Center — Morristown, New Jersey, United States
• Roswell Park Cancer Center Institute — Buffalo, New York, United States
• Hudson Valley Cancer Center — Hawthorne, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• West Penn Allegheny Hospital — Pittsburgh, Pennsylvania, United States
• Baylor Sammons Cancer Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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