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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348489
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):
Astex Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: SGI-110 (guadecitabine) Drug: Treatment Choice Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 815 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 17, 2019

Arm Intervention/treatment
Experimental: SGI-110 (guadecitabine)
Intervention: SGI-110 (guadecitabine)
Drug: SGI-110 (guadecitabine)
Investigational Medicinal Product

Active Comparator: Treatment Choice
Intervention: Choice of one: cytarabine, decitabine, or azacitidine
Drug: Treatment Choice
Choice of one: cytarabine, decitabine, or azacitidine

Primary Outcome Measures :
  1. Complete response (CR) [ Time Frame: 3 years ]
  2. Overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Composite CR [ Time Frame: 3 years ]
  2. Number of days alive and out of the hospital [ Time Frame: 3 years ]
  3. Progression-free survival (PFS) [ Time Frame: 3 years ]
  4. Number of red blood cell or platelet transfusions [ Time Frame: 3 years ]
  5. Health-related quality of life (QOL) [ Time Frame: 3 years ]
  6. Duration of CR [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02348489

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Sponsors and Collaborators
Astex Pharmaceuticals, Inc.
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Responsible Party: Astex Pharmaceuticals, Inc. Identifier: NCT02348489    
Other Study ID Numbers: SGI-110-04
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: July 2019
Keywords provided by Astex Pharmaceuticals, Inc.:
Acute Myeloid Leukemia
DNA Hypomethylating Agen
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents