SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
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ClinicalTrials.gov Identifier: NCT02348489 |
Recruitment Status :
Completed
First Posted : January 28, 2015
Results First Posted : January 14, 2021
Last Update Posted : January 14, 2021
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Tracking Information | |||
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First Submitted Date ICMJE | January 22, 2015 | ||
First Posted Date ICMJE | January 28, 2015 | ||
Results First Submitted Date ICMJE | November 11, 2020 | ||
Results First Posted Date ICMJE | January 14, 2021 | ||
Last Update Posted Date | January 14, 2021 | ||
Actual Study Start Date ICMJE | March 19, 2015 | ||
Actual Primary Completion Date | May 31, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction | ||
Official Title ICMJE | 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 | ||
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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia, Myeloid, Acute | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
815 | ||
Original Estimated Enrollment ICMJE |
800 | ||
Actual Study Completion Date ICMJE | June 17, 2019 | ||
Actual Primary Completion Date | May 31, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | 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:
i. Poor performance status (ECOG) score of 2-3. ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:
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. 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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, United Kingdom, United States | ||
Removed Location Countries | Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT02348489 | ||
Other Study ID Numbers ICMJE | SGI-110-04 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Astex Pharmaceuticals, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Astex Pharmaceuticals, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Astex Pharmaceuticals, Inc. | ||
Verification Date | December 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |