Table 2.
Ongoing clinical trials of interest for TP53-mutated MDS and AML
| AML | Phase | Disease | Identifier |
|---|---|---|---|
| Magrolimab + azacitidine vs. venetoclax + azacitidine OR intensive chemotherapy (ENHANCE-2) | III | ND TP53-mutated AML only | NCT04778397 |
| Azacitidine + venetoclax ± magrolimab (ENHANCE-3) | III | ND AML (including TP53-mutated) | NCT05079230 |
| Magrolimab + venetoclax + azacitidine | I/II | ND and R/R AML | NCT04435691 |
Multiarm study:
|
I/II | ND, R/R, and postinduction maintenance AML | NCT04778410 |
| Decitabine + cytarabine + arsenic trioxide | II | ND AML | NCT03381781 |
| Sabatolimab + venetoclax + azacitidine | ND AML | NCT04150029 | |
| APR-246 + venetoclax + azacitidine | I | ND AML | NCT04214860 |
| CC-90009 + venetoclax + azacitidine | ND and R/R AML | NCT04336982 | |
| Gamma-delta T cells | I | MRD-positive AML | NCT05001451 |
| NK cells | I | R/R AML | NCT04220684 |
| NCT04023071 | |||
| NCT04623944 | |||
| AML/MDS | |||
| CAR-T cells targeting CD123, CD33, CD135, CLL1-CD33, NKG2D receptor, Lewis Y | I | R/R AML, high-risk myeloid neoplasms | NCT03018405 |
| NCT01864902 | |||
| NCT02159495 | |||
| NCT03795779 | |||
| APR-246 + azacitidine | II | Posttransplant AML, MDS maintenance | NCT03931291 |
| Magrolimab + azacitidine | I/II | ND and R/R AML, ND and R/R MDS | NCT03248479 |
| MDS | |||
| APR-246 ± azacitidine | III | ND TP53-mutated MDS only | NCT03745716 |
| Magrolimab ± azacitidine (ENHANCE-1) | III | ND HR-MDS | NCT04313881 |
| Sabatolimab, hypomethylating agent (STIMULUS) | II, III | ND HR-MDS, CMML | NCT03946670 |
| NCT04266301 | |||
| APR-548 + azacitidine | I | ND MDS | NCT04638309 |
Abbreviations: CAR, chimeric antigen receptor; CMML, chronic myelomonocytic leukemia; ND, newly diagnosed; NK, natural killer.