Table 1.
Baseline patient characteristics
| Characteristic, n (%) | CPX-351 (n = 53) | 7 + 3 (n = 39) | Nominal P value* |
|---|---|---|---|
| Age, y | |||
| 60-69 | 37 (70) | 33 (85) | .10 |
| 70-75 | 16 (30) | 6 (15) | |
| Male | 34 (64) | 23 (59) | .61 |
| ECOG performance status | |||
| 0 | 18 (34) | 17 (44) | .35 |
| 1 | 31 (58) | 20 (51) | .49 |
| 2 | 4 (8) | 2 (5) | .30 |
| AML subtype | |||
| Therapy-related AML | 11 (21) | 9 (23) | .79 |
| AML with antecedent MDS | |||
| With prior HMA | 14 (26) | 14 (36) | .33 |
| Without prior HMA | 8 (15) | 5 (13) | .23 |
| AML with antecedent CMML | 3 (6) | 0 | .19 |
| de novo AML with MDS karyotype | 17 (32) | 11 (28) | .69 |
| Cytogenetic risk by NCCN | |||
| Favorable | 3/49 (6) | 0 | .18 |
| Intermediate | 25/49 (51) | 18/37 (49) | .83 |
| Poor | 21/49 (43) | 19/37 (51) | .43 |
| Genetic risk by ELN 2017 | |||
| Favorable | 5/51 (10) | 0 | .06 |
| Intermediate | 14/51 (27) | 14/38 (37) | .35 |
| Adverse | 32/51 (63) | 24/38 (63) | .97 |
| Median bone marrow blasts (range), % | 30 (4.5, 87) | 28 (7, 68) | .24 |
| WBC count <20 000/μL | 48 (91) | 35 (90) | .80 |
| Last response prior to alloHCT | |||
| CR + CRi | 40 (75) | 24 (62) | .15 |
| CR | 30 (57) | 19 (49) | .45 |
| CRi | 10 (19) | 5 (13) | .17 |
| No response | 13 (25) | 15 (38) | .15 |
| Median HCT comorbidity index (range) | 4 (0, 8) | 3 (0, 8) | .65 |
| Transplant donor | |||
| HLA-identical sibling | 11 (21) | 3 (8) | .06 |
| Haploidentical | 4 (8) | 5 (13) | .19 |
| Matched unrelated | 26 (49) | 19 (49) | .97 |
| Mismatched unrelated | 2 (4) | 2 (5) | .37 |
| Unknown/missing | 7 (13) | 9 (23) | .22 |
| Graft source | |||
| Bone marrow | 4 (8) | 1 (3) | .23 |
| Cord blood | 1 (2) | 1 (3) | .49 |
| Peripheral blood | 40 (75) | 27 (69) | .51 |
| Unknown/missing | 8 (15) | 10 (26) | .21 |
| Conditioning regimen † | |||
| Myeloablative | 9/45 (20) | 5/31 (16) | .22 |
| Reduced intensity | 23/45 (51) | 18/31 (58) | .55 |
| Total lines of treatment for patients who were nonresponders or relapsed before alloHCT ‡ | 13 | 14 | .24 |
| 1 | 5 | 2 | |
| 2 | 3 | 6 | |
| 3 | 4 | 2 | |
| 4 | 1 | 3 | |
| 5 | 0 | 0 | |
| 6 | 0 | 1 |
CIBMTR, Center for International Blood and Marrow Transplant Research; CMML, chronic myelomonocytic leukemia; ECOG, Eastern Cooperative Oncology Group; HMA, hypomethylating agent; NCCN, National Comprehensive Cancer Network; WBC, white blood cell.
*
All P values are nominal and do not imply statistical significance.
†
Conditioning regimen intensity classified by CIBMTR criteria.21
‡
Total lines of treatment, including study treatment and additional treatment (≥second line) received after completion of study treatment and before alloHCT.