Best hematological and MRD response across phases
| . | Patients who started consolidation (N = 86) . | Patients who started maintenance (N = 36) . | ||||
|---|---|---|---|---|---|---|
| . | During induction (cycles 1 to 2) . | During consolidation (cycles 3 to 5) . | During induction (cycles 1 to 2) . | During consolidation (cycles 3 to 5) . | During induction + consolidation . | During maintenance (cycles ≥6) . |
| Best response, n (%) | ||||||
| CR | 69* (80.2) | 63 (73.3) | 26 (72.2) | 34 (94.4) | 34** (94.4) | 30 (83.3) |
| CRh | 14† (16.3) | 7 (8.1) | 9 (25) | 2 (5.6) | 2 (5.6) | 1 (2.8) |
| CRi (without CRh) | 1‡ (1.2) | 1 (1.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Blast-free hypoplastic or aplastic bone marrow (without CRi) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Partial remission | 1 (1.2) | 0 (0) | 1 (2.8) | 0 (0) | 0 (0) | 0 (0) |
| Nonresponse | 1 (1.2) | 1 (1.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Hematological relapse | 0 (0) | 6 (7) | 0 (0) | 0 (0) | 0 (0) | 2 (5.6) |
| Progressive disease | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (2.8) |
| Unevaluable/no response data | 0 (0) | 8 (9.3) | 0 (0) | 0 (0) | 0 (0) | 2 (5.6) |
| CR/CRh/CRi | 84 (97.7) | 71 (82.6) | 35 (97.2) | 36 (100) | 36 (100) | 31 (86.1) |
| Best MRD response, n (%) | ||||||
| Evaluable MRD assessment, N1 | 72 | 49 | 30 | 23 | 30 | 14 |
| MRD CR§ | 44/72‖ (61.1) | 29/49 (59.1) | 22/30 (73.3) | 21/23 (91.3) | 24/30†† (80.0) | 8/14 (57.1) |
| MRD remission§ | 11/72¶ (15.2) | 3/49 (6.1) | 4/30 (13.3) | 1/23 (4.3) | 3/30 (10.0) | 3/14 (21.4) |
| No MRD remission§ | 14/72# (19.4) | 17/49 (34.6) | 4/30 (13.3) | 1/23 (4.3) | 3/30 (10.0) | 3/14 (21.4) |
| No MRD assessment | 17/86 (16.3) | 37/86 (43.0) | 6/36 (16.7) | 13/36 (36.1) | 6/36 (16.7) | 22/36 (61.1) |
| . | Patients who started consolidation (N = 86) . | Patients who started maintenance (N = 36) . | ||||
|---|---|---|---|---|---|---|
| . | During induction (cycles 1 to 2) . | During consolidation (cycles 3 to 5) . | During induction (cycles 1 to 2) . | During consolidation (cycles 3 to 5) . | During induction + consolidation . | During maintenance (cycles ≥6) . |
| Best response, n (%) | ||||||
| CR | 69* (80.2) | 63 (73.3) | 26 (72.2) | 34 (94.4) | 34** (94.4) | 30 (83.3) |
| CRh | 14† (16.3) | 7 (8.1) | 9 (25) | 2 (5.6) | 2 (5.6) | 1 (2.8) |
| CRi (without CRh) | 1‡ (1.2) | 1 (1.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Blast-free hypoplastic or aplastic bone marrow (without CRi) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Partial remission | 1 (1.2) | 0 (0) | 1 (2.8) | 0 (0) | 0 (0) | 0 (0) |
| Nonresponse | 1 (1.2) | 1 (1.2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Hematological relapse | 0 (0) | 6 (7) | 0 (0) | 0 (0) | 0 (0) | 2 (5.6) |
| Progressive disease | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (2.8) |
| Unevaluable/no response data | 0 (0) | 8 (9.3) | 0 (0) | 0 (0) | 0 (0) | 2 (5.6) |
| CR/CRh/CRi | 84 (97.7) | 71 (82.6) | 35 (97.2) | 36 (100) | 36 (100) | 31 (86.1) |
| Best MRD response, n (%) | ||||||
| Evaluable MRD assessment, N1 | 72 | 49 | 30 | 23 | 30 | 14 |
| MRD CR§ | 44/72‖ (61.1) | 29/49 (59.1) | 22/30 (73.3) | 21/23 (91.3) | 24/30†† (80.0) | 8/14 (57.1) |
| MRD remission§ | 11/72¶ (15.2) | 3/49 (6.1) | 4/30 (13.3) | 1/23 (4.3) | 3/30 (10.0) | 3/14 (21.4) |
| No MRD remission§ | 14/72# (19.4) | 17/49 (34.6) | 4/30 (13.3) | 1/23 (4.3) | 3/30 (10.0) | 3/14 (21.4) |
| No MRD assessment | 17/86 (16.3) | 37/86 (43.0) | 6/36 (16.7) | 13/36 (36.1) | 6/36 (16.7) | 22/36 (61.1) |
CR was defined as 5% or less bone marrow blasts and no evidence of disease and was further characterized according to the extent of recovery of peripheral blood counts as follows: CR with full recovery (platelet count of >100 × 103/µL and ANC of >1 × 103/µL), CRh (platelet count of >50 × 103/µL and ANC of >0.5 × 103/µL), or CRi (platelet count of >100 × 103/µL or ANC of >1 × 103/µL). MRD response was defined as MRD level <10−4 measured by real-time quantitative PCR (or multicolor flow cytometry). MRD complete response was defined as no detectable leukemic cells by quantitative PCR (or flow cytometry).
Of the 69 patients with best response of CR before consolidation, 52 had best response of CR, 4 had CRh, 6 had hematological relapse, and 7 patients had unevaluable or no data during consolidation (supplemental Table 2A).
Of the 14 patients with best response of CRh before consolidation, 9 had best response of CR during consolidation (supplemental Table 2A).
This patient went on to achieve CR during blinatumomab consolidation therapy (supplemental Table 2A).
Percentage with respect to N1.
Of the 44 patients who had MRD CR before consolidation, 25 had best response of MRD CR, 1 had MRD remission, 8 lost remission, and 10 had no MRD assessment during consolidation (supplemental Table 3A).
Of the 11 patients who had best response of MRD remission before consolidation, 2 had best response of MRD CR, 1 maintained MRD remission, and 8 had no MRD assessment during consolidation (supplemental Table 3A).
All 14 patients had no MRD assessment during consolidation (supplemental Table 3A).
Of the 34 patients with best response of CR before maintenance, 30 had best response of CR, 2 relapsed, 1 had progressive disease, and 1 had unevaluable or no data during maintenance (supplemental Table 2B).
Of the 24 patients with best response of MRD complete response before maintenance, 8 had best response of MRD complete response, 1 had MRD remission, 2 had no MRD remission, and 13 had no MRD assessment during maintenance (supplemental Table 3B).