Table 2. Event-Free Survival, Overall Survival, Minimal Residual Disease Remission, and Allogeneic Hematopoietic Stem Cell Transplant Outcomes.
| No. (%) | Absolute difference, % (95% CI) |
||
|---|---|---|---|
| Blinatumomab (n = 54) | Consolidation chemotherapy (n = 54) | ||
| Primary end point | |||
| Event-free survival | 37 (69) | 23 (43) | |
| Events | 17 (31) | 31 (57) | |
| Total relapses | 13 (24) | 29 (54) | |
| Isolated bone marrow | 6 (11) | 12 (22) | |
| M2 marrow after achievement of complete remission | 4 (7) | 12 (22) | |
| Combined bone marrow | 2 (4) | 0 | |
| Central nervous system extramedullary | 1 (2) | 2 (4) | |
| Extramedullary at other sitesa | 0 | 3 (6) | |
| Death from any cause other than relapse | 4 (7)b | 2 (4)c | |
| Failure to achieve complete remission after treatment with investigational product | 0 | 0 | |
| Second malignancy | 0 | 0 | |
| Secondary end points | |||
| Overall survival | |||
| Death from any cause | 8 (15) | 16 (30) | |
| Minimal residual disease remission by minimal residual disease status at baseline (minimal residual disease evaluable set)d,e,f | Blinatumomab remission, No./total evaluable (%) | Consolidation chemotherapy remission, No./total evaluable (%) | |
| Minimal residual disease remission | 17/20 (85) | 20/23 (87) | −2.0 (−31.2 to 28.0) |
| No minimal residual disease remission | 27/29 (93) | 6/25 (24) | 69.1 (45.4 to 85.5) |
| Total | 44/49 (90) | 26/48 (54) | 35.6 (15.6 to 52.5) |
| Blinatumomab (n = 48) | Consolidation chemotherapy (n = 38) | ||
| Subset of patients who underwent allogeneic hematopoietic stem cell transplant in second complete remission | |||
| Time to transplant, median (range), mo | 1.9 (1 to 3) | 1.7 (1 to 3) | |
| Stem cell source | |||
| Peripheral blood | 20 (42) | 9 (24) | |
| Bone marrow | 24 (50) | 24 (63) | |
| Cord blood | 4 (8) | 5 (13) | |
| Donor type | |||
| Matched sibling | 12 (25) | 10 (26) | |
| Haploidentical relatedg | 13 (27) | 10 (26) | |
| Matched unrelated | 17 (35) | 12 (32) | |
| Mismatched unrelated | 6 (13) | 6 (16) | |
| Receipt of conditioning total body irradiation | 27 (56) | 18 (47) | |
| Receipt of conditioning chemotherapy | 21 (44) | 20 (53) | |
| Died after receiving a hematopoietic stem cell transplant | |||
| Transplant-related deathh | 4 (8) | 4 (11) | |
| Due to relapse/disease progression | 3 (6) | 8 (21) | |
Abbreviation: PCR, polymerase chain reaction.
Testicular extramedullary relapse was not observed in either group.
All events occurred after allogeneic hematopoietic stem cell transplant: hemophagocytic lymphohistiocytosis (in the context of acute graft rejection), respiratory failure due to pneumonia, hepatic failure (developing after graft-vs-host disease), and infection (in the context of graft-vs-host disease).
Causes of death included acute respiratory failure (occurring after allogeneic hematopoietic stem cell transplant) and fungal sinusitis.
Minimal residual disease remission is defined as <10-4 blast cells. Minimal residual disease remission was analyzed at end of treatment (cycle 1, day 29) of investigational product. Patients who were part of the minimal residual disease evaluable set and were missing postbaseline disease assessments were considered not to have achieved a response. Patients assessed included those in the minimal residual disease evaluable set who had minimal residual disease status at baseline as defined earlier and minimal residual disease response at end of treatment (cycle 1, day 29) of investigational product for the respective assessment methods.
The minimal residual disease evaluable set included patients for whom evaluable baseline minimal residual disease marker could be found with either of the minimal residual disease assessment methods: PCR or flow cytometry.
For minimal residual disease status at baseline, if both a PCR and flow cytometry value was available, then the minimal residual disease PCR value was taken because PCR is more sensitive.
Includes mismatched sibling, haploidentical mother, and haploidentical father.
Causes of transplant-related death in the blinatumomab group included hepatic failure (n = 1), respiratory failure (n = 1), hemophagocytic lymphohistiocytosis (n = 1), and graft-vs-host disease with fungal infection (n = 1). Causes in the consolidation chemotherapy group were fungal sinusitis (n = 1), myocardial infarction (n = 1), multiorgan failure (n = 1), and acute respiratory failure (n = 1).