Baseline characteristics of patients treated at a single institution with off-trial venetoclax and azacitidine and patients who received venetoclax and azacitidine in the setting of a clinical trial at the same single institution
| . | Off-trial venetoclax patients without prior hypomethylating agent who received treatment . | Off-trial venetoclax patients with prior hypomethylating agent who received treatment . | All off-trial venetoclax patients who received treatment . | Clinical trial patients . | Off-trial vs clinical trial,*P . |
|---|---|---|---|---|---|
| N | 26 | 4 | 30 | 33 | |
| Median age, y | 72 | 71 | 72 | 75 | .073 |
| Baseline white blood cell count, ×109/L | 2.8 | 7.7 | 3.3 | 2.5 | .440 |
| Median baseline blast, % | 59 | 26 | 55 | 40 | .334 |
| Prior hypomethylating agent, n (%) | 0 (0) | 4 (100) | 4 (13.3) | 0 (0) | .046 |
| Antecedent hematologic disorder, n (%) | 2 (7.7) | 4 (100) | 6 (20.0) | 10 (30.3) | .397 |
| Treatment-related AML, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 6. (18.2) | 1.000 |
| Cytogenetic risk group, n (%) | |||||
| Intermediate | 15 (57.7) | 0 (0) | 15 (50.0) | 20 (60.6) | .516 |
| Unfavorable | 10 (38.5) | 1 (25) | 11 (36.7) | 12 (36.4) | |
| Unknown | 1 (3.9) | 2 (50) | 3 (10.0) | 1 (3) | |
| Complex cytogenetics, n (%) | 8 (30.8) | 1 (25) | 9 (30.0) | 5 (15.2) | .175 |
| Monosomal karyotype, n (%) | 4 (15.4) | 1 (25) | 5 (16.7) | 5 (15.2) | .860 |
| FLT3 ITD, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 5 (15.2) | .265 |
| IDH1/IDH2, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 12 (36.4) | .095 |
| ASXL1, n (%) | 9 (34.6) | 2 (50) | 11 (36.7) | 5 (15.2) | .081 |
| TP53, n (%) | 3 (11.5) | 2 (50) | 5 (16.7) | 3 (9.1) | .462 |
| ELN risk group, n (%) | |||||
| Adverse | 17 (65.4) | 3 (75) | 20 (66.7) | 18 (54.5) | .143 |
| Intermediate | 2 (7.7) | 1 (25) | 3 (10) | 10 (30.3) | |
| Favorable | 7 (26.9) | 0 (0) | 7 (23.3) | 5 (15.2) | |
| Would have been eligible for clinical trial, n (%) | 9 (34.6) | 0 (0) | 9 (30) | N/A | N/A |
| . | Off-trial venetoclax patients without prior hypomethylating agent who received treatment . | Off-trial venetoclax patients with prior hypomethylating agent who received treatment . | All off-trial venetoclax patients who received treatment . | Clinical trial patients . | Off-trial vs clinical trial,*P . |
|---|---|---|---|---|---|
| N | 26 | 4 | 30 | 33 | |
| Median age, y | 72 | 71 | 72 | 75 | .073 |
| Baseline white blood cell count, ×109/L | 2.8 | 7.7 | 3.3 | 2.5 | .440 |
| Median baseline blast, % | 59 | 26 | 55 | 40 | .334 |
| Prior hypomethylating agent, n (%) | 0 (0) | 4 (100) | 4 (13.3) | 0 (0) | .046 |
| Antecedent hematologic disorder, n (%) | 2 (7.7) | 4 (100) | 6 (20.0) | 10 (30.3) | .397 |
| Treatment-related AML, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 6. (18.2) | 1.000 |
| Cytogenetic risk group, n (%) | |||||
| Intermediate | 15 (57.7) | 0 (0) | 15 (50.0) | 20 (60.6) | .516 |
| Unfavorable | 10 (38.5) | 1 (25) | 11 (36.7) | 12 (36.4) | |
| Unknown | 1 (3.9) | 2 (50) | 3 (10.0) | 1 (3) | |
| Complex cytogenetics, n (%) | 8 (30.8) | 1 (25) | 9 (30.0) | 5 (15.2) | .175 |
| Monosomal karyotype, n (%) | 4 (15.4) | 1 (25) | 5 (16.7) | 5 (15.2) | .860 |
| FLT3 ITD, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 5 (15.2) | .265 |
| IDH1/IDH2, n (%) | 5 (19.2) | 0 (0) | 5 (16.7) | 12 (36.4) | .095 |
| ASXL1, n (%) | 9 (34.6) | 2 (50) | 11 (36.7) | 5 (15.2) | .081 |
| TP53, n (%) | 3 (11.5) | 2 (50) | 5 (16.7) | 3 (9.1) | .462 |
| ELN risk group, n (%) | |||||
| Adverse | 17 (65.4) | 3 (75) | 20 (66.7) | 18 (54.5) | .143 |
| Intermediate | 2 (7.7) | 1 (25) | 3 (10) | 10 (30.3) | |
| Favorable | 7 (26.9) | 0 (0) | 7 (23.3) | 5 (15.2) | |
| Would have been eligible for clinical trial, n (%) | 9 (34.6) | 0 (0) | 9 (30) | N/A | N/A |
ASXL1, additional sex combs like 1; ELN, European LeukemiaNetwork; FLT3, FMS-like tyrosine kinase 3; IDH, isocitrate dehydrogenase; ITD, internal tandem duplication; N/A, not available; TP53, tumor protein 53.
Comparison of off-trial patients with clinical trial patients includes all off-trial patients, with or without hypomethylating agent.