At a glance
ClinicalIndex Comparison Record- ✓Adults aged ≥18 with cytologically or histologically confirmed AML (excluding acute promyelocytic leukemia) per WHO 2008, with bone marrow or peripheral blood blast counts ≥20%
- ✓Prior standard intensive chemotherapy with cytarabine and anthracycline, with primary refractoriness or relapse after induction, with or without prior hematopoietic cell transplantation (HCT)
- ✓ECOG performance status 0-2
- ✓Peripheral blood or bone marrow blasts ≥5% at randomization
- ✕Clinically active CNS or extramedullary AML (except leukemia cutis)
- ✕BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis)
- ✕First relapse after initial induction if remission duration >12 months or if good candidate for HCT
- ✕Second malignancy currently requiring active therapy (except stable/responding breast or prostate cancer on endocrine therapy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia
In Brief
A Phase 3 clinical trial evaluating guadecitabine and Treatment Choice (TC) for Acute Myeloid Leukemia. Completed, enrolled 302 participants across 95 sites in 15 countries.
Detailed Summary
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine \[HiDAC\]; mitoxantrone, etoposide, and cytarabine \[MEC\]; or fludarabine, cytarabine, granulocyte colony stimulating factor \[G-CSF\], +/- idarubicin \[FLAG/FLAG-Ida\]). * Low intensity (low dose cytarabine \[LDAC\], decitabine, or azacitidine). * BSC.
Study Details
Timeline
Interventions
In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. In Cycle 2, the guadecitabine dose will be 60 mg/m\^2 for either 10 days (Days 1-5 and 8-12) or 5 days (Days 1-5 only) based on assessment of disease response, and hematological recovery by Day ≥28.
* High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida). * Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine. * Best Supportive Care (BSC).