Patient characteristics
| . | All eligible patients (n = 100) . | Patients proceeding to alloSCT (n = 90) . |
|---|---|---|
| Sex, female/male | 33/67 | 30/60 |
| Age, y | 53 (27-65) | 53 (27-65) |
| IGHV unfavorable, n (%)* | 87 of 91 (96) | 78 of 82 (95) |
| FISH karyotype, n (%) | 78 of 100 (78) | 72 of 90 (80) |
| del 17p− ± others, n (%) | 16 of 78 (22) | 13 of 72 (18) |
| del 11q− ± others (except del 17p−), n (%) | 28 of 78 (36) | 26 of 72 (36) |
| +12 ± others (except del 17p−, del 11q−), n (%) | 4 of 78 (5%) | 4 of 72 (6) |
| del 13q− only, n (%) | 12 of 78 (15) | 12 of 72 (17) |
| Others, n (%) | 5 of 78 (6) | 5 of 72 (7) |
| Normal FISH karyotype, n (%) | 13 of 78 (17) | 12 of 72 (17) |
| Maximum Binet stage A/B/C/unknown | 10/42/45/3 | 9/40/40/1 (10%/44%/44%/1%) |
| Time from diagnosis, months (range) | 54 (2-270) | 57 (2-270) |
| Previous regimens, n (range) | 4 (1-11) | 4 (1-11) |
| Previous autoSCT, n (%) | 31 of 98 (32%) | 28 of 90 (31%) |
| Purine analogue resistant, n (%)† | 48 of 98 (49%) | 42 of 90 (47%) |
| ECOG score 0/1/unknown | 65/29/6 | 62/27/1 (69%/30%/1%) |
| EBMT indication 1/2/3/0‡ | 3/16/48/31 | 3/13/45/29 (3%/14%/50%/32%) |
| Alemtuzumab last regimen before transplant | NA | 22 of 90 (24%) |
| Refractory disease at SCT | NA | 21 of 89 (24%) |
| BM infiltration at SCT (%) | NA | 15 (0–100) |
| HCT-CI score at SCT 0/1/2/>2 | NA | 67/12/6/3 |
| Alternative donor§ | NA | 54 of 90 (60%) |
| Weisdorf score SIB/WMUD/PMUD/MM/unclassifiable¶ | NA | 36/12/27/2/13 (40%/13%/30%/2%/15%) |
| Conditioning FC/TCD/FBC/unknown | NA | 65/12/12/1 (72%/13%/13%/1%) |
| . | All eligible patients (n = 100) . | Patients proceeding to alloSCT (n = 90) . |
|---|---|---|
| Sex, female/male | 33/67 | 30/60 |
| Age, y | 53 (27-65) | 53 (27-65) |
| IGHV unfavorable, n (%)* | 87 of 91 (96) | 78 of 82 (95) |
| FISH karyotype, n (%) | 78 of 100 (78) | 72 of 90 (80) |
| del 17p− ± others, n (%) | 16 of 78 (22) | 13 of 72 (18) |
| del 11q− ± others (except del 17p−), n (%) | 28 of 78 (36) | 26 of 72 (36) |
| +12 ± others (except del 17p−, del 11q−), n (%) | 4 of 78 (5%) | 4 of 72 (6) |
| del 13q− only, n (%) | 12 of 78 (15) | 12 of 72 (17) |
| Others, n (%) | 5 of 78 (6) | 5 of 72 (7) |
| Normal FISH karyotype, n (%) | 13 of 78 (17) | 12 of 72 (17) |
| Maximum Binet stage A/B/C/unknown | 10/42/45/3 | 9/40/40/1 (10%/44%/44%/1%) |
| Time from diagnosis, months (range) | 54 (2-270) | 57 (2-270) |
| Previous regimens, n (range) | 4 (1-11) | 4 (1-11) |
| Previous autoSCT, n (%) | 31 of 98 (32%) | 28 of 90 (31%) |
| Purine analogue resistant, n (%)† | 48 of 98 (49%) | 42 of 90 (47%) |
| ECOG score 0/1/unknown | 65/29/6 | 62/27/1 (69%/30%/1%) |
| EBMT indication 1/2/3/0‡ | 3/16/48/31 | 3/13/45/29 (3%/14%/50%/32%) |
| Alemtuzumab last regimen before transplant | NA | 22 of 90 (24%) |
| Refractory disease at SCT | NA | 21 of 89 (24%) |
| BM infiltration at SCT (%) | NA | 15 (0–100) |
| HCT-CI score at SCT 0/1/2/>2 | NA | 67/12/6/3 |
| Alternative donor§ | NA | 54 of 90 (60%) |
| Weisdorf score SIB/WMUD/PMUD/MM/unclassifiable¶ | NA | 36/12/27/2/13 (40%/13%/30%/2%/15%) |
| Conditioning FC/TCD/FBC/unknown | NA | 65/12/12/1 (72%/13%/13%/1%) |
alloSCT indicates allogeneic stem cell transplantation; autoSCT, autologous stem cell transplantation; BM, bone marrow; EBMT, European Group for Blood and Marrow Transplantation; ECOG, Eastern Cooperative Oncology Group; FBC, FC + busulfan; FC, fludarabine-cyclophosphamide; FISH, fluorescence in situ hybridization; HCT-CI, hematopoietic cell transplantation comorbidity index; IGHV, immunoglobulin variable heavy-chain; MM, mismatched unrelated donor (Weisdorf and coworkers33 ); NA, not applicable; PMUD, partially matched unrelated donor; SIB, 10 of 10 allele-matched sibling; TCD, FC + total body irradiation 2Gy + in vivo alemtuzumab; and WMUD, well-matched unrelated donor.
Unmutated (> 98% homology to germline) or VH3–21.
Nonresponse or relapse within 6 months after fludarabine monotherapy or fludarabine-cyclophosphamide/fludarabine-rituximab combinations.
1, relapse within 24 months after intensive therapy; 2, del 17p−; 3, purine analogue refractory or relapse within 12 months after purine analogues; 0, other indication as defined in the protocol.
Unrelated donor or mismatched relative.
In 13 patients sufficient HLA typing information for assignment of score was not available (unclassifiable).