Study characteristics
| Author, y . | Phase . | Design . | Malignancy type . | Eligibility criteria . | Venetoclax regimen, N . | Comparator regimen, N . | Timing of reporting of AEs . | Antimicrobial prophylaxis . | G-CSF use . | Median follow-up time (mo) . |
|---|---|---|---|---|---|---|---|---|---|---|
| DiNardo, 2020 | 3 | Double blind | AML | Untreated disease and ineligible for standard induction therapy | Venetoclax + azacitidine, N = 286 | Placebo + azacitidine, N = 145 | 30 d after discontinuation of the study drug | Antimicrobial prophylaxis was received by 83% and 81% of patients assigned to venetoclax and comparator, respectively | Venetoclax arm: 32% Comparator arm: NR | 20.5 |
| Fischer, 2019 | 3 | Open-label | CLL | Untreated and comorbidities | Venetoclax + Obinutuzumab, N = 216 | Chlorambucil + Obinutuzumab, N = 216 | 28 d after the final dose of venetoclax or 90 d after the final dose of obinutuzumab, whichever is longer. Grade 3 and 4 IAEs were collected until 2 y after the final study drug dose | When clinically indicated, antimicrobial prophylaxis was permitted | Venetoclax arm: 43.5% Comparator arm: 45.8% | 28.1 |
| Kater, 2022 | 3 | Open-label | CLL | Untreated and either older (>65 y) or comorbidities | Venetoclax + ibrutinib, N = 106 | Chlorambucil + obinutuzumab, N = 105 | Unclear | NR | Venetoclax arm: NR Comparator arm: NR | 27.7 |
| Kumar, 2020 | 3 | Doubleblind | MM | Relapsed or refractory disease | Venetoclax + bortezomib + dexamethasone N = 194 | Placebo + bortezomib + dexamethasone, N = 97 | 30 d after the final dose of the study drug | All patients received varicella zoster virus prophylaxis. Initially, antibacterial and PJP prophylaxis were given at the discretion of the study investigator; however, later they were required for all patients receiving venetoclax | Venetoclax arm: NR Comparator arm: NR | 18.7 |
| Seymour, 2018 | 3 | Open-label | CLL | Relapsed or refractory disease | Venetoclax + rituximab, N = 194 | Bendamustine + rituximab, N = 195 | 28 d after the final dose of the study drug, up to a maximum of 2 y for venetoclax, or 90 d after the final dose of rituximab | Antimicrobial prophylaxis was permitted when clinically indicated | Venetoclax arm: NR Comparator arm: NR | 23.8 |
| Wei, 2020 | 3 | Double blind | AML | Previously untreated disease and ineligible for intensive chemotherapy | Venetoclax + cytarabine, N = 143 | Placebo + cytarabine, N = 68 | 30 d after the final dose of the study drug | All subjects with absolute neutrophil counts below 500 were admistered antimicrobial prophylaxis | Venetoclax arm: NR Comparator arm: NR | 12.0 |
| Zinzani, 2020 | 2 | Open-label | FL | Relapsed or refractory disease | Venetoclax + bendamustine + rituximab, N = 51 | Bendamustine + rituximab, N = 51 | 30 d after the final dose of the study drug or 90 d after the final dose of rituximab | NR | Venetoclax arm: 42.9% Comparator arm: 34.0% | 18.2 and 18.4 in the venetoclax and control arms, respectively |
| Author, y . | Phase . | Design . | Malignancy type . | Eligibility criteria . | Venetoclax regimen, N . | Comparator regimen, N . | Timing of reporting of AEs . | Antimicrobial prophylaxis . | G-CSF use . | Median follow-up time (mo) . |
|---|---|---|---|---|---|---|---|---|---|---|
| DiNardo, 2020 | 3 | Double blind | AML | Untreated disease and ineligible for standard induction therapy | Venetoclax + azacitidine, N = 286 | Placebo + azacitidine, N = 145 | 30 d after discontinuation of the study drug | Antimicrobial prophylaxis was received by 83% and 81% of patients assigned to venetoclax and comparator, respectively | Venetoclax arm: 32% Comparator arm: NR | 20.5 |
| Fischer, 2019 | 3 | Open-label | CLL | Untreated and comorbidities | Venetoclax + Obinutuzumab, N = 216 | Chlorambucil + Obinutuzumab, N = 216 | 28 d after the final dose of venetoclax or 90 d after the final dose of obinutuzumab, whichever is longer. Grade 3 and 4 IAEs were collected until 2 y after the final study drug dose | When clinically indicated, antimicrobial prophylaxis was permitted | Venetoclax arm: 43.5% Comparator arm: 45.8% | 28.1 |
| Kater, 2022 | 3 | Open-label | CLL | Untreated and either older (>65 y) or comorbidities | Venetoclax + ibrutinib, N = 106 | Chlorambucil + obinutuzumab, N = 105 | Unclear | NR | Venetoclax arm: NR Comparator arm: NR | 27.7 |
| Kumar, 2020 | 3 | Doubleblind | MM | Relapsed or refractory disease | Venetoclax + bortezomib + dexamethasone N = 194 | Placebo + bortezomib + dexamethasone, N = 97 | 30 d after the final dose of the study drug | All patients received varicella zoster virus prophylaxis. Initially, antibacterial and PJP prophylaxis were given at the discretion of the study investigator; however, later they were required for all patients receiving venetoclax | Venetoclax arm: NR Comparator arm: NR | 18.7 |
| Seymour, 2018 | 3 | Open-label | CLL | Relapsed or refractory disease | Venetoclax + rituximab, N = 194 | Bendamustine + rituximab, N = 195 | 28 d after the final dose of the study drug, up to a maximum of 2 y for venetoclax, or 90 d after the final dose of rituximab | Antimicrobial prophylaxis was permitted when clinically indicated | Venetoclax arm: NR Comparator arm: NR | 23.8 |
| Wei, 2020 | 3 | Double blind | AML | Previously untreated disease and ineligible for intensive chemotherapy | Venetoclax + cytarabine, N = 143 | Placebo + cytarabine, N = 68 | 30 d after the final dose of the study drug | All subjects with absolute neutrophil counts below 500 were admistered antimicrobial prophylaxis | Venetoclax arm: NR Comparator arm: NR | 12.0 |
| Zinzani, 2020 | 2 | Open-label | FL | Relapsed or refractory disease | Venetoclax + bendamustine + rituximab, N = 51 | Bendamustine + rituximab, N = 51 | 30 d after the final dose of the study drug or 90 d after the final dose of rituximab | NR | Venetoclax arm: 42.9% Comparator arm: 34.0% | 18.2 and 18.4 in the venetoclax and control arms, respectively |
NR, not reported.