Study name (Other identifier) | Study type | Sample size | Tx group | Drug(s) and dosage(s) | Frequency | Duration of Tx |
---|---|---|---|---|---|---|
AZA-AML-001 [20] (NCT01074047) | RCT | 241 | HMA | AZA 75 mg/m2/d | 7 d/28-d cycle | Minimum 6 cycles |
CALGB 11,002 [19] (NCT01420926) | RCT | 82 | HMA | DEC 20 mg/m2/d | 10 d/28-d cycle | 4 cycles to achieve remission, 2 more if not achieved. Continuation therapy: same dosage, 5 d/28-d cycle. Maintenance therapy is same |
Short 2019 [21] | RCT | 28 | HMA | DEC 5-d 20 mg/m2/d | 5 consecutive d every 4–8 weeks | – |
43 | DEC 10-d 20 mg/m2/d | 10 consecutive d every 4–8 weeks | – | |||
VIALE-A [6] (NCT02993523) | RCT | 145 | HMA | AZA 75 mg/m2/d | 7 d/28-d cycle | – |
286 | VEN + HMA | VEN 400 mg/d + AZA 75 mg/m2/d | Daily for 28 d; 7 d/28-d cycle | – | ||
DiNardo 2018 [22] (NCT02203773) | Single arm | 84 | VEN + HMA | VEN 400 mg/d + AZA 75 mg/m2/d | – | – |
31 | VEN 400 mg + DEC 20 mg/m2/d | – | – | |||
DiNardo 2020 [23] (NCT03404193) | Single arm | 37 | VEN + HMA | VEN escalation over 3 d to 400 mg (100, 200, 400) + DEC 20 mg/m2/d | 10 d /28-d cycle | Until remission. Remission: VEN given 1–21, instead of 1–28. Decrease to 14–10-7 depending on cytopenia |
Kadia 2015 [24] | RO | 293 | IC/HMA | HDAC-based/HMA | – | – |
Short 2020 [25] (NCT01786343) | RO | 202 | IC/HMA ± VEN | IDAC- or HDAC-based/HMA ± VEN | – | – |
Lindsley 2019 [26] (NCT01696084) | RCT | 156 | IC | 7 + 3 cytarabine 100 mg/m2/d + daunorubicin 60 mg/m2/d | 1–7 d; 1–3 d | Second induction 5 + 2 |
Prochazka 2019 [13] (AML-HD98A; AML-HD98B; AMLSG-07–04) | RCT | 98 | IC | IC | – | – |
Chiche 2021 [27] | RO | 103 | IC | CPX-351 (daunorubicin 44 mg/m2 + cytarabine 100 mg/m2) | d1 and d3 | 1 or 2 cycles |
Desoutter 2014 [28] | RO | 96 | HMA | AZA 75 mg/m2/d | 7 d/28-d cycle | 4–6 cycles |