Table 1.

Ongoing clinical trials in AML involving BH3 mimetics

Clinicaltrials.gov identifierDisease state(s)Clinical trialTargetPhase
NCT02993523 AML (elderly; treatment naive) Azacitidine + venetoclax (vs azacitidine + placebo) BCL-2 
NCT03069352 AML (elderly; treatment naive) Low-dose cytarabine + venetoclax (vs low-dose cytarabine + placebo) BCL-2 
NCT02670044 R/R AML Cobimetinib (MEK inhibitor) or idasanutlin (HDM2 inhibitor) + venetoclax BCL-2 1B/2 
NCT03214562 R/R and naive AML FLAG-IDA/venetoclax in patients with newly diagnosed or R/R AML BCL-2 1B/2 
NCT02920541 R/R and elderly treatment naive Dose-escalation study of oral administration of S055746 in patients with AML or MDS BCL-2 
ACTRN12616000445471 Elderly newly diagnosed Cytarabine, idarubicin with venetoclax BCL-2 1/2 
NCT03194932 R/R (2-20 years old) Venetoclax in combination with chemotherapy in pediatric patients with R/R AML or acute leukemia of ambiguous lineage BCL-2 1/2 
CT03082209 Solid tumor, AML or DLBCL (all R/R) TRAIL receptor agonist ABBV-621 in subjects with previously treated solid tumors and hematologic malignancies (segment II: ABBV-621 + venetoclax) BCL-2 
NCT02391480 Cancers, R/R AML, MM, NHL Safety and pharmacokinetics of ABBV-075 in subjects with cancer (expansion cohort of ABBV-075 and venetoclax) BCL-2 
NCT03537482 R/R hematologic malignancies A phase I study of safety, tolerability, pharmacokinetic and pharmacodynamics property of orally administered APG-2575 in patients with hematologic malignancies BCL-2 
NCT02979366 R/R, secondary to MDS and elderly treatment naive S64315, a Mcl-1 inhibitor, administered intravenously in patients with AML or MDS MCL-1 
NCT02675452 MM, R/R AML AMG 176 first in human trial in subjects with R/R MM and subjects with R/R AML MCL-1 
NCT03218683 R/R hematologic malignancies AZD5991 in R/R hematologic malignancies MCL-1 
Clinicaltrials.gov identifierDisease state(s)Clinical trialTargetPhase
NCT02993523 AML (elderly; treatment naive) Azacitidine + venetoclax (vs azacitidine + placebo) BCL-2 
NCT03069352 AML (elderly; treatment naive) Low-dose cytarabine + venetoclax (vs low-dose cytarabine + placebo) BCL-2 
NCT02670044 R/R AML Cobimetinib (MEK inhibitor) or idasanutlin (HDM2 inhibitor) + venetoclax BCL-2 1B/2 
NCT03214562 R/R and naive AML FLAG-IDA/venetoclax in patients with newly diagnosed or R/R AML BCL-2 1B/2 
NCT02920541 R/R and elderly treatment naive Dose-escalation study of oral administration of S055746 in patients with AML or MDS BCL-2 
ACTRN12616000445471 Elderly newly diagnosed Cytarabine, idarubicin with venetoclax BCL-2 1/2 
NCT03194932 R/R (2-20 years old) Venetoclax in combination with chemotherapy in pediatric patients with R/R AML or acute leukemia of ambiguous lineage BCL-2 1/2 
CT03082209 Solid tumor, AML or DLBCL (all R/R) TRAIL receptor agonist ABBV-621 in subjects with previously treated solid tumors and hematologic malignancies (segment II: ABBV-621 + venetoclax) BCL-2 
NCT02391480 Cancers, R/R AML, MM, NHL Safety and pharmacokinetics of ABBV-075 in subjects with cancer (expansion cohort of ABBV-075 and venetoclax) BCL-2 
NCT03537482 R/R hematologic malignancies A phase I study of safety, tolerability, pharmacokinetic and pharmacodynamics property of orally administered APG-2575 in patients with hematologic malignancies BCL-2 
NCT02979366 R/R, secondary to MDS and elderly treatment naive S64315, a Mcl-1 inhibitor, administered intravenously in patients with AML or MDS MCL-1 
NCT02675452 MM, R/R AML AMG 176 first in human trial in subjects with R/R MM and subjects with R/R AML MCL-1 
NCT03218683 R/R hematologic malignancies AZD5991 in R/R hematologic malignancies MCL-1 

DLBCL, diffuse large B-cell lymphoma; HDM2, human double minute 2; MDS, myelodysplastic syndrome; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; R/R, relapsed/refractory.

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