Patient characteristics
| Characteristic . | Clofarabine . | Clofarabine plus LD cytarabine . | Total . |
|---|---|---|---|
| No. patients | 16 | 54 | 70 |
| Median age, y (range) | 71 (60-83) | 70 (60-82) | 71 (60-83) |
| Diagnosis, no. patients (%) | |||
| AML | 16 (100) | 50 (92) | 66 (94) |
| RAEB-2 | 2 (4) | 2 (3) | |
| CMML | 2 (4) | 2 (3) | |
| Secondary AML/MDS, no. patients (%) | 7 (41) | 28 (52) | 35 (50) |
| MDS | 6 (38) | 18 (33) | 24 (34) |
| Other AHD | 1 (3)* | 6 (11)† | 7 (10) |
| Solid tumor history | 1 (3)* | 7 (13)‡ | 8 (11) |
| Prior therapy with DNMTI, no. patients (%) | 2 (12) | 9 (17) | 11 (16) |
| FAB classification (AML), no. patients (%) | |||
| M0 | 1 (6) | 1 (2) | 2 (3) |
| M1 | 3 (6) | 3 (5) | |
| M2 | 2 (12) | 5 (10) | 7 (11) |
| M4/M5 | 5 (32) | 8 (16) | 13 (20) |
| M6 | 1 (6) | 3 (6) | 4 (6) |
| Not assigned by FAB | 7 (44) | 30 (59)§ | 37 (55) |
| WHO classification, no. patients (%) | |||
| Recurrent cytogenetic abnormality | 1 (2) | 1 (1) | |
| AML with multilineage dysplasia | 7 (44) | 17 (31) | 24 (34) |
| Therapy-related AML | 1 (6) | 3 (6) | 4 (6) |
| Not otherwise categorized | 7 (44) | 25 (46) | 32 (46) |
| Not available or diagnosis of MDS | 1 (6) | 8 (15) | 9 (13) |
| Karyotype, no. patients (%) | |||
| Diploid | 6 (38) | 27 (50) | 33 (47) |
| Unfavorable | 5 (31) | 20 (37) | 25 (36) |
| −5/−7 | 2 (13) | 14 (26) | 16 (23) |
| del(11)(q23) | 1 (2) | 1 (1) | |
| Complex | 5 (31) | 9 (17) | 14 (20) |
| Flt3, no. patients (%) | |||
| Available | 13 (81) | 50 (93) | 63 (90) |
| Abnormal | 2 (15) | 6 (12) | 8 (11) |
| ITD | 2 (15) | 5 (10)‖ | 7 (14) |
| D835 | 3 (6)‖ | 3 (4) |
| Characteristic . | Clofarabine . | Clofarabine plus LD cytarabine . | Total . |
|---|---|---|---|
| No. patients | 16 | 54 | 70 |
| Median age, y (range) | 71 (60-83) | 70 (60-82) | 71 (60-83) |
| Diagnosis, no. patients (%) | |||
| AML | 16 (100) | 50 (92) | 66 (94) |
| RAEB-2 | 2 (4) | 2 (3) | |
| CMML | 2 (4) | 2 (3) | |
| Secondary AML/MDS, no. patients (%) | 7 (41) | 28 (52) | 35 (50) |
| MDS | 6 (38) | 18 (33) | 24 (34) |
| Other AHD | 1 (3)* | 6 (11)† | 7 (10) |
| Solid tumor history | 1 (3)* | 7 (13)‡ | 8 (11) |
| Prior therapy with DNMTI, no. patients (%) | 2 (12) | 9 (17) | 11 (16) |
| FAB classification (AML), no. patients (%) | |||
| M0 | 1 (6) | 1 (2) | 2 (3) |
| M1 | 3 (6) | 3 (5) | |
| M2 | 2 (12) | 5 (10) | 7 (11) |
| M4/M5 | 5 (32) | 8 (16) | 13 (20) |
| M6 | 1 (6) | 3 (6) | 4 (6) |
| Not assigned by FAB | 7 (44) | 30 (59)§ | 37 (55) |
| WHO classification, no. patients (%) | |||
| Recurrent cytogenetic abnormality | 1 (2) | 1 (1) | |
| AML with multilineage dysplasia | 7 (44) | 17 (31) | 24 (34) |
| Therapy-related AML | 1 (6) | 3 (6) | 4 (6) |
| Not otherwise categorized | 7 (44) | 25 (46) | 32 (46) |
| Not available or diagnosis of MDS | 1 (6) | 8 (15) | 9 (13) |
| Karyotype, no. patients (%) | |||
| Diploid | 6 (38) | 27 (50) | 33 (47) |
| Unfavorable | 5 (31) | 20 (37) | 25 (36) |
| −5/−7 | 2 (13) | 14 (26) | 16 (23) |
| del(11)(q23) | 1 (2) | 1 (1) | |
| Complex | 5 (31) | 9 (17) | 14 (20) |
| Flt3, no. patients (%) | |||
| Available | 13 (81) | 50 (93) | 63 (90) |
| Abnormal | 2 (15) | 6 (12) | 8 (11) |
| ITD | 2 (15) | 5 (10)‖ | 7 (14) |
| D835 | 3 (6)‖ | 3 (4) |
LD indicates low-dose; AHD, antecedent hematologic disorder; IM, insufficient metaphases; ITD, internal tandem duplication; D835, amino acid mutation at codon aspartate 835; and DNMTI, DNA methyltransferase inhibitor (decitabine or azacitidine).
One patient with history of both non-Hodgkin lymphoma (NHL) and carcinoma of the prostate (received radiation therapy [XRT] and chemotherapy for NHL and XRT for carcinoma of the prostate).
One patient with history of both mantle cell lymphoma and MDS.
One patient with carcinoma of the prostate and MDS, and 1 patient with history of renal cell carcinoma and CMML (of the 7 solid tumor patients, 3 received XRT only, 1 each chemotherapy or XRT, respectively, and 2 patients neither XRT nor chemotherapy).
One patient with biphenotypic acute leukemia.
Two patients with both ITD and D835.