Clinical Trials /

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

NCT02348489

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: SGI-110-04
  • NCT ID: NCT02348489

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DrugSynonymsArms
SGI-110 (guadecitabine)SGI-110 (guadecitabine)
Treatment ChoiceTreatment Choice

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SGI-110 (guadecitabine)ExperimentalIntervention: SGI-110 (guadecitabine)
  • SGI-110 (guadecitabine)
Treatment ChoiceActive ComparatorIntervention: Choice of one: cytarabine, decitabine, or azacitidine
  • Treatment Choice

Eligibility Criteria

        Inclusion Criteria:

        Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic
        leukemia) according to 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.

          4. 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 Cockroft-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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response (CR)
Time Frame:3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Composite CR
Time Frame:3 years
Safety Issue:
Description:
Measure:Number of days alive and out of the hospital
Time Frame:3 years
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:3 years
Safety Issue:
Description:
Measure:Number of red blood cell or platelet transfusions
Time Frame:3 years
Safety Issue:
Description:
Measure:Health-related quality of life (QOL)
Time Frame:3 years
Safety Issue:
Description:
Measure:Duration of CR
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Astex Pharmaceuticals

Trial Keywords

  • AML
  • Acute Myeloid Leukemia
  • SGI-110
  • DNA Hypomethylating Agen

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