Ongoing investigational therapies for frontline acute myeloid leukemia
| ClinicalTrials.gov identifier . | Study . | Phase . | Target/agent . | Key patient population . |
|---|---|---|---|---|
| NCT03826992 | CPX-351 + venetoclax | 1 | Venetoclax is a BCL-2 inhibitor. | Age <40 y relapsed/refractory |
| NCT03471260 | Venetoclax + ivosidenib + azacitidine | 1/2 | Ivosidenib is an IDH1 inhibitor. | Age ≥18 y IDH1 mutant, relapsed/refractory |
| NCT03248479 | Magrolimab vs magrolimab + azacitidine | 1 | Magrolimab is an anti-CD47 mAb. | Age ≥18 y relapsed/refractory or treatment-naïve and unsuitable for intensive chemotherapy |
| NCT04086264 | IMGN632 vs | 1/2 | IMGN632 is an anti-CD123 ADC. | Age ≥18 y CD123-positive relapsed/refractory or treatment-naïve |
| IMGN632 + azacitidine vs | ||||
| IMGN632 + venetoclax vs | ||||
| IMGN632 + azacitidine + venetoclax | ||||
| NCT04150029 | MGB453 + azacitidine + venetoclax | 2 | MGB453 is an anti-TIM-3 mAb. | Age ≥18 y treatment-naïve, unsuitable for intensive chemotherapy |
| NCT03701308 | 7 + 3 vs 7 + 3 + uproleselan (GMI-1271) | 3 | Uproleselan is an E-selectin inhibitor. | Age ≥60 y, eligible for induction |
| NCT03258931 | Crenolanib + 7 + 3 vs midostaurin + 7 + 3 | 3 | Crenolanib is an FLT3 inhibitor. | Age 18-60 y FLT3-ITD and/or D835 mutations, de novo AML |
| NCT04140487 | Azacitidine, venetoclax, and gilteritinib | 1/2 | Gilteritinib is an FLT3 inhibitor. | Age ≥18 y relapsed/refractory or newly diagnosed FLT-3-mutated AML (for phase 2 portion) |
| NCT03709758 | Venetoclax plus 7 + 3 | 1 | Venetoclax is a BCL-2 inhibitor. | Age 18-60 y without FLT3 mutation or inv16 or t(8;21) |
| NCT03113643 | Azacitidine, venetoclax, and SL-401 | 1 | SL-401 is a recombinant IL-3 genetically fused to truncated diphtheria toxin payload. | Age ≥18 y with CD123/IL3RA expression on myeloblasts |
| ClinicalTrials.gov identifier . | Study . | Phase . | Target/agent . | Key patient population . |
|---|---|---|---|---|
| NCT03826992 | CPX-351 + venetoclax | 1 | Venetoclax is a BCL-2 inhibitor. | Age <40 y relapsed/refractory |
| NCT03471260 | Venetoclax + ivosidenib + azacitidine | 1/2 | Ivosidenib is an IDH1 inhibitor. | Age ≥18 y IDH1 mutant, relapsed/refractory |
| NCT03248479 | Magrolimab vs magrolimab + azacitidine | 1 | Magrolimab is an anti-CD47 mAb. | Age ≥18 y relapsed/refractory or treatment-naïve and unsuitable for intensive chemotherapy |
| NCT04086264 | IMGN632 vs | 1/2 | IMGN632 is an anti-CD123 ADC. | Age ≥18 y CD123-positive relapsed/refractory or treatment-naïve |
| IMGN632 + azacitidine vs | ||||
| IMGN632 + venetoclax vs | ||||
| IMGN632 + azacitidine + venetoclax | ||||
| NCT04150029 | MGB453 + azacitidine + venetoclax | 2 | MGB453 is an anti-TIM-3 mAb. | Age ≥18 y treatment-naïve, unsuitable for intensive chemotherapy |
| NCT03701308 | 7 + 3 vs 7 + 3 + uproleselan (GMI-1271) | 3 | Uproleselan is an E-selectin inhibitor. | Age ≥60 y, eligible for induction |
| NCT03258931 | Crenolanib + 7 + 3 vs midostaurin + 7 + 3 | 3 | Crenolanib is an FLT3 inhibitor. | Age 18-60 y FLT3-ITD and/or D835 mutations, de novo AML |
| NCT04140487 | Azacitidine, venetoclax, and gilteritinib | 1/2 | Gilteritinib is an FLT3 inhibitor. | Age ≥18 y relapsed/refractory or newly diagnosed FLT-3-mutated AML (for phase 2 portion) |
| NCT03709758 | Venetoclax plus 7 + 3 | 1 | Venetoclax is a BCL-2 inhibitor. | Age 18-60 y without FLT3 mutation or inv16 or t(8;21) |
| NCT03113643 | Azacitidine, venetoclax, and SL-401 | 1 | SL-401 is a recombinant IL-3 genetically fused to truncated diphtheria toxin payload. | Age ≥18 y with CD123/IL3RA expression on myeloblasts |
AML, acute myeloid leukemia; mAb, monoclonal antibody, ADC, antibody-drug conjugate; ITD, internal tandem duplication.