Table 2.
Clinical studies evaluating Venetoclax-based regimens in relapsing/refractory AML patients.
| Reference | Trial Phase | Patient Number | Median Age (range) | Combination Therapy | Cytogenetic Risk for ELN | CR+CRi (%) | MRD Negativity (%) | Median OS (months) |
|---|---|---|---|---|---|---|---|---|
| Konopleva et al (2016) [27] | II | 32 | 71 (19–84) | None | Intermediate/Adverse | 19% | ND | 4.7 |
| DiNardo et al (2018) [28] | I/II | 43 | 68 (25–83) | HMA (AZA) LDAC | Intermediate/Adverse | 12% | ND | 3 |
| Aldoss et al (2018) [29] | Out of trial | 33 | 62 (19–81) | HMA (AZA or DEC) | Intermediate/Adverse | 51 | 53% in CR+CRi | NR |
| Aldoss et al (2019) [75] | Out of trial | 90 | 59 (18–81) | HMA (AZA or DEC) | Intermediate/Adverse | 46 | 64 | 16.6 |
| Morsia et al (2020) [102] | Out of trial | 42 | 65 (18–79) | HMA (AZA or DEC) | Intermediate/Adverse | 33 | ND | 15 |
| Wang et al (2020) [33] | Out of trial | 40 | 63 (20–88) | HMA (AZA) or LDAC | Intermediate/Adverse | 23 | ND | NR |
| DiNardo et al (2020) [13]; Maiti et al (2021) [34] | II | 83 | 72 (63–89) | HMA (DEC d10) | Intermediate/Adverse | 41 | 51 | 6.8 |
| DiNardo et al (2021) [19] | II | 23 | 47 (22–66) | FLAG-Ida | Non-APL | 61 | 79 | NR; 68% 1-yr OS |
| Kim et al (2021) [25] | I/II | 26 | 54 (26–72) | CPX-351 | Intermediate/Adverse | 46 | 73 | 7.1; 39% 1-yr OS |
APL indicates acute promyelocytic leukemia; HMA hypomethylating agent; CR complete remission; CRi complete remission with incomplete hematological recovery; OS overall survival; LDAc low-dose adjuvant chemotherapy; ND not done; NR not reached.