Select ongoing trials including patients with myeloid neoplasm with mutated TP53
| Experimental drug . | Eligibility criteria . | Phase . | Primary outcome measures . | Secondary outcome measures . | Identifier . |
|---|---|---|---|---|---|
| Entrectinib + ASTX727 (cedazuridine + decitabine) | Relapsed/refractory TP53-mutated AML | 1 | Incidence of dose-limiting toxicities | Adverse events, response rates, EFS, OS, etc | NCT05396859 |
| Sodium stibogluconate | MDS and AML with TP53 mutation | 2 | Overall response rate | Adverse events | NCT04906031 |
| Decitabine + arsenic trioxide (ATO) | MDS and AML with TP53 mutation | 1 | Adverse effects | Response rates | NCT03855371 |
| SL172154 +/– azacitidine +/– venetoclax | HR-MDS and AML | 1 | Safety and tolerability Determine phase 2 dosing | Preliminary evidence for antitumor activity, PK | NCT05275439 |
| Sabatolimab + HMA (azacitidine/IV or oral decitabine) | HR-MDS | 2 | Treatment-emergent adverse events | CR, PFS, and OS, etc | NCT04878432 |
| Tagraxofusp +/– azacitidine | AML with prior HMA exposure | 2 | CR rate | PFS and OS, etc | NCT05442216 |
| Atorvastatin | Solid tumors and relapsed AML | 1 | Change in conformation of mutated p53 (IHC staining) | Change in caspase 3 Change in Ki-67 | NCT03560882 |
| Maplirpacept + azacitidine +/– venetoclax | Newly diagnosed AML and R/R MM/lymphoma | 1 | Safety | PK, response rates, DOR, and others | NCT03530683 |
| SAR443579 | Pediatric AML, B-ALL, HR-MDS, BPDCN | 1/2 | Toxicity CR rate | Dosing for expansion phase, adverse events, etc | NCT05086315 |
| Experimental drug . | Eligibility criteria . | Phase . | Primary outcome measures . | Secondary outcome measures . | Identifier . |
|---|---|---|---|---|---|
| Entrectinib + ASTX727 (cedazuridine + decitabine) | Relapsed/refractory TP53-mutated AML | 1 | Incidence of dose-limiting toxicities | Adverse events, response rates, EFS, OS, etc | NCT05396859 |
| Sodium stibogluconate | MDS and AML with TP53 mutation | 2 | Overall response rate | Adverse events | NCT04906031 |
| Decitabine + arsenic trioxide (ATO) | MDS and AML with TP53 mutation | 1 | Adverse effects | Response rates | NCT03855371 |
| SL172154 +/– azacitidine +/– venetoclax | HR-MDS and AML | 1 | Safety and tolerability Determine phase 2 dosing | Preliminary evidence for antitumor activity, PK | NCT05275439 |
| Sabatolimab + HMA (azacitidine/IV or oral decitabine) | HR-MDS | 2 | Treatment-emergent adverse events | CR, PFS, and OS, etc | NCT04878432 |
| Tagraxofusp +/– azacitidine | AML with prior HMA exposure | 2 | CR rate | PFS and OS, etc | NCT05442216 |
| Atorvastatin | Solid tumors and relapsed AML | 1 | Change in conformation of mutated p53 (IHC staining) | Change in caspase 3 Change in Ki-67 | NCT03560882 |
| Maplirpacept + azacitidine +/– venetoclax | Newly diagnosed AML and R/R MM/lymphoma | 1 | Safety | PK, response rates, DOR, and others | NCT03530683 |
| SAR443579 | Pediatric AML, B-ALL, HR-MDS, BPDCN | 1/2 | Toxicity CR rate | Dosing for expansion phase, adverse events, etc | NCT05086315 |
BPDCN, blastic plasmacytoid dendritic cell neoplasm.