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. 2022 May 6;5(2):380–400. doi: 10.20517/cdr.2021.125

Table 1.

Clinical trials evaluating venetoclax-based combination regimens

Drug Regimen Treatment Category Mutation (if required for eligibility) Clinicaltrials.gov identifier Target Number of patient enrollment++ Phase Year of study initiation
Azacitidine  +  Venetoclax Frontline NCT03466294 42 II 2018
Venetoclax + Decitabine Both+ NCT03404193 400 II 2018
ASTX727 (Decitabine and Cedazuridine) +  Venetoclax
Both+ NCT04657081 124 I/II 2021
ASTX727 (Decitabine and Cedazuridine) + Venetoclax Both+ NCT04746235 40 II 2021
Venetoclax + Cladribine + LDAC induction followed by Cladribine+ LDAC + Azacitidine Frontline NCT03586609 85 II 2018
LDAC  +  Venetoclax^^ Frontline NCT02287233 94 I/II 2014
LDAC + Venetoclax vs LDAC  +  placebo Frontline NCT03069352 211 III 2017
CPX-351 (Liposome-encapsulated Daunorubicin-Cytarabine) + Venetoclax Both+ In RR subset, (+) RAS pathway activating mutation: KIT, HRAS/NRAS/KRAS, BRAF, CBL or PTPN11 or loss of function mutation of NF1 NCT03629171 52 II 2018
Ivosidenib (IDH1 inhibitor) + Venetoclax +/- Azacitidine Both+ IDH1+ NCT03471260 30 I/II 2018
Enasidenib (IDH2 inhibitor) + Venetoclax Both+ IDH2 (+) NCT04092179 48 I/II 2020
Gilteritinib (FLT3 inhibitor)  + Venetoclax^^ Salvage NCT03625505 61 I 2018
Gilteritinib (FLT3 inhibitor)  + Azacitidine + Venetoclax Salvage FLT3 NCT04140487 42 I/II 2019
Gilteritinib (FIT3 inhibitor)  + ASTX727 (Decitabine and Cedazuridine) + Venetoclax Salvage (phase I), Both (phase II)+ FLT3 NCT05010122 42 I/II 2021
Quizartinib (FLT3 inhibitor)  +  Venetoclax Salvage FLT3 NCT03735875 32 I/II 2019
Quizartinib (FLT3 inhibitor) + Decitabine + Venetoclax Both+ FLT3 NCT03661307 52 I/II 2018
S64315 (MCL-1 inhibitor) + Venetoclax Salvage NCT03672695 40 I 2018
AZD5991 (MCL-1 inhibitor) + Venetoclax** Salvage NCT03218683 144 I/II 2017
Pevonedistat (NAE inhibitor) +/- Venetoclax + Azacitidine Frontline NCT03862157 40 I/II 2019
Cobimetinib (MEK inhibitor)  +  Venetoclax;
Idasanutlin (MDM2 inhibitor)  + Venetoclax^^
Salvage NCT02670044 88 I 2016
Trametinib (MEK inhibitor)  + Azacitidine + Venetoclax Both+ (+) RAS pathway activating mutation in R/R subset NCT04487106 40 II 2020
Dinaciclib (CDK inhibitor) +  Venetoclax Salvage NCT03484520 48 I 2018
Alvocidib (CDK inhibitor) + Venetoclax^^ Salvage NCT03441555 36 I 2018
CYC065 (CDK inhibitor)  + Venetoclax Salvage NCT04017546 25 I 2019
APR-246 + Venetoclax +/- Azacitidine Frontline TP53 + NCT04214860 51 I 2019
Magrolimab + Venetoclax + Azacitidine or MEC or CC-486 (oral Azacitidine) Both+ NCT04778410 164 II 2021
Magrolimab + Azacitidine + Venetoclax Frontline (phase I), Salvage (phase II) NCT04435691 98 I/II 2021
ALX148 (Evorpacept) + Venetoclax + Azacitidine Both+ NCT04755244 97 I/II 2021
TTI-622 (SIRPα-IgG4 Fc) + AZA +/-VEN Frontline TP53 +/- NCT03530683 150 I 2018
Ph I/IIb DS-1594 (Menin inhibitor) +/- Azacitidine + Venetoclax or miniHCVD Salvage Presence of MLL rearrangement, NPM1 (+) NCT03735875 32 I/II 2019

MEC Mitoxantrone, Etoposide, and Cytarabine. vs. ^^Completed. **Suspended. +Both frontline and salvage therapy. ++Actual number of patients enrolled for completed studies.