Patient characteristics according to randomization arm
| Characteristic . | Watch-and-wait arm . | Auto-arm . |
|---|---|---|
| Number of patients | 111 | 112 |
| Age, y | ||
| Median | 53 | 54 |
| Range | 35-65 | 31-65 |
| Time diagnosis-randomization, mo | ||
| Median | 20.9 | 21.1 |
| Range | 3.7-252.7 | 2.7-203 |
| Sex | ||
| Male | 86 (77) | 75 (67) |
| Female | 25 (23) | 37 (33) |
| Binet stage | ||
| A progressive | 14 (13) | 16 (14) |
| B | 76 (68) | 72 (64) |
| C | 21 (19) | 24 (22) |
| Disease status at randomization | ||
| CR | 63 (57) | 69 (62) |
| VGPR | 31 (28) | 29 (26) |
| nPR | 17 (15) | 14 (12) |
| Patient randomization | ||
| After first-line therapy | 92 (83) | 92 (82) |
| After second-line therapy | 19 (17) | 20 (18) |
| First-line treatments | ||
| Fludarabine | 10 (9) | 9 (8) |
| CHOP then fludarabine | 50 (45) | 49 (44) |
| Fludarabine + cyclophosphamide | 20 (18) | 24 (21) |
| FCR | 3 (3) | 0 |
| CHOP ± rituximab | 10 (9) | 5 (4) |
| Rituximab-cladribine | 3 (3) | 3 (3) |
| Other associations | 11 (10) | 11 (10) |
| Unknown | 4 (3) | 11 (10) |
| Cytogenetics | ||
| Del 17p | ||
| Positive | 0 (0) | 2 (2) |
| Negative | 50 (45) | 51 (46) |
| Unknown | 61 (55) | 59 (53) |
| Del 11q | ||
| Positive | 15 (13) | 5 (4) |
| Negative | 42 (38) | 50 (45) |
| Unknown | 54 (49) | 57 (51) |
| Country | ||
| France | 50 (45) | 49 (44) |
| United Kingdom | 30 (27) | 33 (30) |
| Germany | 18 (16) | 18 (16) |
| Switzerland | 5 (5) | 5 (4) |
| EBMT centers | 8 (7) | 7 (6) |
| Characteristic . | Watch-and-wait arm . | Auto-arm . |
|---|---|---|
| Number of patients | 111 | 112 |
| Age, y | ||
| Median | 53 | 54 |
| Range | 35-65 | 31-65 |
| Time diagnosis-randomization, mo | ||
| Median | 20.9 | 21.1 |
| Range | 3.7-252.7 | 2.7-203 |
| Sex | ||
| Male | 86 (77) | 75 (67) |
| Female | 25 (23) | 37 (33) |
| Binet stage | ||
| A progressive | 14 (13) | 16 (14) |
| B | 76 (68) | 72 (64) |
| C | 21 (19) | 24 (22) |
| Disease status at randomization | ||
| CR | 63 (57) | 69 (62) |
| VGPR | 31 (28) | 29 (26) |
| nPR | 17 (15) | 14 (12) |
| Patient randomization | ||
| After first-line therapy | 92 (83) | 92 (82) |
| After second-line therapy | 19 (17) | 20 (18) |
| First-line treatments | ||
| Fludarabine | 10 (9) | 9 (8) |
| CHOP then fludarabine | 50 (45) | 49 (44) |
| Fludarabine + cyclophosphamide | 20 (18) | 24 (21) |
| FCR | 3 (3) | 0 |
| CHOP ± rituximab | 10 (9) | 5 (4) |
| Rituximab-cladribine | 3 (3) | 3 (3) |
| Other associations | 11 (10) | 11 (10) |
| Unknown | 4 (3) | 11 (10) |
| Cytogenetics | ||
| Del 17p | ||
| Positive | 0 (0) | 2 (2) |
| Negative | 50 (45) | 51 (46) |
| Unknown | 61 (55) | 59 (53) |
| Del 11q | ||
| Positive | 15 (13) | 5 (4) |
| Negative | 42 (38) | 50 (45) |
| Unknown | 54 (49) | 57 (51) |
| Country | ||
| France | 50 (45) | 49 (44) |
| United Kingdom | 30 (27) | 33 (30) |
| Germany | 18 (16) | 18 (16) |
| Switzerland | 5 (5) | 5 (4) |
| EBMT centers | 8 (7) | 7 (6) |
Values are n (%) unless otherwise noted.
CHOP indicates cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and prednisone/prednisolone; CR, complete remission; EBMT, European Group for Blood and Marrow Transplantation; FCR, fludarabine, cyclophosphamide, and rituximab; nPR, nodular partial remission; and VGPR, very good partial remission.