Response and minimal residual disease status during the 12-cycle treatment and follow-up
| Clinical response . | Cycle 3 N = 45 . | Cycle 7 N = 41 . | Cycle 12 N = 40∗ . | Best response N = 45 . |
|---|---|---|---|---|
| Overall response, % | 78 | 100 | 98† | 100 |
| CR(u)/CRi‡, % | 2 | 15‡ | 38 | 42 |
| PR, % | 76 | 85 | 60 | 58 |
| Clinical response . | Cycle 3 N = 45 . | Cycle 7 N = 41 . | Cycle 12 N = 40∗ . | Best response N = 45 . |
|---|---|---|---|---|
| Overall response, % | 78 | 100 | 98† | 100 |
| CR(u)/CRi‡, % | 2 | 15‡ | 38 | 42 |
| PR, % | 76 | 85 | 60 | 58 |
| MRD response . | Cycle 12∗ . | Cycle 18 . | Cycle 24 . | |
|---|---|---|---|---|
| Peripheral Blood N = 42 . | Bone marrow N = 39 . | Peripheral Blood . | ||
| N = 29 . | N = 25 . | |||
| Detectable >10−2, % | 2 | 2 | ||
| Detectable 10−4 to 10−2, % | 31 | 21 | 10 | 4 |
| Undetectable <10−4, % | 67 | 77 | 90 | 96 |
| MRD response . | Cycle 12∗ . | Cycle 18 . | Cycle 24 . | |
|---|---|---|---|---|
| Peripheral Blood N = 42 . | Bone marrow N = 39 . | Peripheral Blood . | ||
| N = 29 . | N = 25 . | |||
| Detectable >10−2, % | 2 | 2 | ||
| Detectable 10−4 to 10−2, % | 31 | 21 | 10 | 4 |
| Undetectable <10−4, % | 67 | 77 | 90 | 96 |
CR, complete repsonse; CRu, unconfirmed CR because of absence of confirmatory bone marrow biopsy; CRi, CR with incomplete hematologic recovery; PR, partial response.
Forty patients had clinical response available at cycle 12 and 42 had MRD assessments at cycle 12.
One patient had PR at cycle 7 and progressive disease at cycle 12.
Cycle 3 and cycle 7 CRs are CRu.