SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Summary
Linked Publications
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Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Complete Response (CR) |
79; 71 | 0.482 |
| PRIMARY Overall Survival |
213; 254 | 0.7328 |
| SECONDARY Number of Participants With Composite CR (CRc) |
93; 91 | — |
| SECONDARY Number of Days Alive and Out of the Hospital |
98.1; 105.7 | — |
| SECONDARY Progression-free Survival (PFS) |
159; 166 | — |
| SECONDARY Number of Red Blood Cell or Platelet Transfusions |
16.2; 15.6; 12.5; 14.4 | — |
| SECONDARY Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L |
0.7767; 0.7663; 0.8252; 0.8240; -0.0023; 0.0112 | — |
| SECONDARY Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS |
64.64; 63.58; 72.76; 71.72; 3.28; 3.67 | — |
| SECONDARY Duration of CR |
217; 231 | — |
Eligibility Criteria
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:
- ≥75 years of age OR
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT02348489) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.