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

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

NCT02348489•Astex Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. ≥75 years of age OR
•2. \<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:
•1. Left ventricular ejection fraction (LVEF) ≤50%.
•2. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
•3. Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
+5 more criteria

Exclusion Criteria

•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.

Locations (135)

Mayo Clinic Cancer Center

Scottsdale, Arizona, United States

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

Key Dates

Start Date

March 19, 2015

Primary Completion Date

May 31, 2018

Completion Date

June 17, 2019

Last Updated

August 27, 2024

Enrollment

815

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

SGI-110 (guadecitabine)

DRUG

Treatment Choice

DRUG

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222

Leukemia, Myeloid, Acute

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RECRUITING

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

NCT06580106

Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

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