SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Completed · Phase 3

Conditions studied: Leukemia, Myeloid, Acute

In brief

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

Key facts

Study ID

NCT02348489

Run by

Astex Pharmaceuticals, Inc.

People needed

815

Starts

2015-03-19

Expected to finish

2019-06-17

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.
• Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.
• Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:
• ≥75 years of age OR
• <75 years of age with at least 1 of the following:
• i. Poor performance status (ECOG) score of 2-3.
• ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:
• Left ventricular ejection fraction (LVEF) ≤50%.
• Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
• Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
• Chronic stable angina or congestive heart failure controlled with medication.
• iii. Liver transaminases >3 × upper limit of normal (ULN).
• iv. Other contraindication(s) to anthracycline therapy (must be documented).
• v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.
• Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.

You may not qualify if…

• Candidate for intensive remission induction chemotherapy at the time of enrollment.
• Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.
• Known extramedullary central nervous system (CNS) AML.
• Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.
• Prior treatment with decitabine or azacitidine.
• Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.
• Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.
• Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.
• Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Where it is running

• Scripps Cancer Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• John Theurer Cancer Center at Hackensack — Hackensack, New Jersey, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• University Hospitals Monarch Medical Center — Cleveland, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Mayo Clinic Cancer Center — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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