Response to treatment
| . | CLL2-BIO . | CLL2-BIG . | CLL2-BAG . | Total . |
|---|---|---|---|---|
| Debulking, no. of patients (%) | 11 | 8 | 8 | 27 |
| iwCLL response | ||||
| PR | 6 (55) | 2 (25) | 4 (50) | 12 (44) |
| SD | 5 (46) | 3 (38) | 3 (38) | 11 (41) |
| PD | 0 | 2 (25) | 0 | 2 (7) |
| Missing | 0 | 1 (13) | 1 (13) | 2 (7) |
| Induction, no. of patients (%) | 21 | 13 | 17 | 51 |
| iwCLL response | ||||
| CR | 0 | 0 | 1 (6) | 1 (2) |
| PR | 16 (76) | 13 (100) | 15 (88) | 44 (86) |
| PR-L | 1 (5) | 0 | 0 | 1 (2) |
| SD | 3 (14) | 0 | 0 | 3 (6) |
| PD | 1 (5) | 0 | 1 (6) | 2 (4) |
| MRD response: PB | ||||
| Undetectable/low, <10−4 | 0 | 3 (23) | 14 (82) | 17 (33) |
| Intermediate, ≥10−4 and <10−2 | 2 (10) | 5 (39) | 2 (12) | 9 (18) |
| Positive, ≥10−2 | 18 (86) | 4 (31) | 0 | 22 (43) |
| Missing | 1 (5) | 1 (8) | 1 (6) | 3 (6) |
| Maintenance, no. of patients (%) | 19 | 13 | 16 | 48 |
| iwCLL response | ||||
| CR | 0 | 0 | 5 (31) | 5 (10) |
| PR | 14 (74) | 11 (85) | 9 (56) | 34 (71) |
| PD | 5 (26) | 1 (8) | 2 (13) | 8 (17) |
| Missing | 0 | 1 (8) | 0 | 1 (2) |
| MRD response: PB* | ||||
| Undetectable/low, <10−4 | 3 (16) | 6 (46) | 10 (63) | 19 (40) |
| Intermediate, ≥10−4 and <10−2 | 7 (37) | 4 (31) | 2 (13) | 13 (27) |
| Positive, ≥10−2 | 9 (47) | 0 | 4 (25) | 13 (27) |
| Missing | 0 | 3 (23) | 0 | 3 (6) |
| MRD response: BM† | ||||
| Undetectable/low, <10−4 | 0 (0.0) | 2 (15.4) | 6 (37.5) | 8 (16.7) |
| Intermediate, ≥10−4 and <10−2 | 1 (5.3) | 1 (7.7) | 2 (12.5) | 4 (8.3) |
| Positive, ≥10−2 | 2 (10.5) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
| Missing | 16 (84.2) | 10 (76.9) | 8 (50.0) | 34 (70.8) |
| . | CLL2-BIO . | CLL2-BIG . | CLL2-BAG . | Total . |
|---|---|---|---|---|
| Debulking, no. of patients (%) | 11 | 8 | 8 | 27 |
| iwCLL response | ||||
| PR | 6 (55) | 2 (25) | 4 (50) | 12 (44) |
| SD | 5 (46) | 3 (38) | 3 (38) | 11 (41) |
| PD | 0 | 2 (25) | 0 | 2 (7) |
| Missing | 0 | 1 (13) | 1 (13) | 2 (7) |
| Induction, no. of patients (%) | 21 | 13 | 17 | 51 |
| iwCLL response | ||||
| CR | 0 | 0 | 1 (6) | 1 (2) |
| PR | 16 (76) | 13 (100) | 15 (88) | 44 (86) |
| PR-L | 1 (5) | 0 | 0 | 1 (2) |
| SD | 3 (14) | 0 | 0 | 3 (6) |
| PD | 1 (5) | 0 | 1 (6) | 2 (4) |
| MRD response: PB | ||||
| Undetectable/low, <10−4 | 0 | 3 (23) | 14 (82) | 17 (33) |
| Intermediate, ≥10−4 and <10−2 | 2 (10) | 5 (39) | 2 (12) | 9 (18) |
| Positive, ≥10−2 | 18 (86) | 4 (31) | 0 | 22 (43) |
| Missing | 1 (5) | 1 (8) | 1 (6) | 3 (6) |
| Maintenance, no. of patients (%) | 19 | 13 | 16 | 48 |
| iwCLL response | ||||
| CR | 0 | 0 | 5 (31) | 5 (10) |
| PR | 14 (74) | 11 (85) | 9 (56) | 34 (71) |
| PD | 5 (26) | 1 (8) | 2 (13) | 8 (17) |
| Missing | 0 | 1 (8) | 0 | 1 (2) |
| MRD response: PB* | ||||
| Undetectable/low, <10−4 | 3 (16) | 6 (46) | 10 (63) | 19 (40) |
| Intermediate, ≥10−4 and <10−2 | 7 (37) | 4 (31) | 2 (13) | 13 (27) |
| Positive, ≥10−2 | 9 (47) | 0 | 4 (25) | 13 (27) |
| Missing | 0 | 3 (23) | 0 | 3 (6) |
| MRD response: BM† | ||||
| Undetectable/low, <10−4 | 0 (0.0) | 2 (15.4) | 6 (37.5) | 8 (16.7) |
| Intermediate, ≥10−4 and <10−2 | 1 (5.3) | 1 (7.7) | 2 (12.5) | 4 (8.3) |
| Positive, ≥10−2 | 2 (10.5) | 0 (0.0) | 0 (0.0) | 2 (4.2) |
| Missing | 16 (84.2) | 10 (76.9) | 8 (50.0) | 34 (70.8) |
BM, bone marrow; PB, peripheral blood; PD, progressive disease; PR, partial remission; PR-L, partial remission with lymphocytosis; SD, stable disease.
Last staging during maintenance (up to 3 months before termination of treatment).
MRD assessment at any time point between final restaging at the end induction and end of maintenance treatment.