blood- and bone marrow cancer
Conditions
Interventions
* SGI-110: 60 mg/m2 SGI-110 given SC daily on Days 1-5 in 28-day cycles.
Treatment should be given for at least 6 cycles in the absence of unacceptable
toxicity or disease progression requiring alte
other treatment parameters, such as duration of treatment and dose adjustment
guidelines, should follow locally approved prescribing information and
institutional standard practice):
- 20 mg cytarab
acute Myeloid Leukemia
randomized
Sponsors
Astex Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and comply with study procedures, and provides written informed consent before any study-specific procedure. 2. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to the 2008 World Health Organization (WHO) classification (bone marrow or peripheral blood blast counts *20%). 3. Performance status (ECOG) of 0-3. 4. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed. 5. Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER: a. *75 years of age OR b. 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. 6. Creatinine clearance as estimated by the Cockroft-Gault (C-G) or other medically acceptable formulas *30 mL/min. 7. Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures during the study and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving treatment with SGI-110 and for at least 3 months after completing treatment.
Exclusion criteria
Exclusion criteria: 1. Candidate for intensive remission induction chemotherapy at the time of enrollment. 2. Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators. 3. Known extramedullary central nervous system (CNS) AML. 4. Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy. 5. Prior treatment with decitabine or azacitidine. 6. Hypersensitivity to decitabine, azacitidine, cytarabine, SGI-110, or any of their excipients. 7. Treated with any investigational drug within 2 weeks of the first dose of study treatment. 8. Total serum bilirubin >2.5 × ULN, except for subjects with Gilbert's Syndrome for whom direct bilirubin is 2 liters per minute (LPM) oxygen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary Endpoints * CR rate based on modified International Working Group (IWG) 2003 AML Response Criteria. * OS, defined as the number of days from randomization to death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints * Composite CR rate (CRc = CR + Complete response with incomplete blood count recovery [CRi] + Complete response with incomplete platelet recovery [CRp]) * Number of days alive and out of the hospital. * Progression-free survival (PFS), defined as the number of days from randomization to disease progression or death, whichever occurs first. * Number of red blood cell (RBC) or platelet transfusions (units) over the duration of the study treatment. * Health-related quality of life (QOL) by EQ-5D (consisting of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale [EQ VAS]). * Duration of CR, defined as the time from first CR to time of relapse. * Incidence and severity of adverse events (AEs). * 30- and 60-day all-cause early mortality. | — |
Countries
The Netherlands
Outcome results
None listed