Baseline characteristics
| Characteristic . | GVAX (n = 30) . | Placebo (n = 27) . | All (N = 57) . | P . |
|---|---|---|---|---|
| Age, median (range) | 64 (27, 75) | 63 (35, 74) | 63 (27, 75) | .38 |
| Patient sex, N (%) | .6 | |||
| Female | 11 (36.7) | 12 (44.4) | 23 (40.4) | |
| Male | 19 (63.3) | 15 (55.6) | 34 (59.6) | |
| Donor age, median (range), y | 28 (19, 67) | 30 (19, 68) | 28 (19, 68) | .17 |
| Donor sex, N (%) | .15 | |||
| Female | 6 (20) | 11 (40.7) | 17 (29.8) | |
| Male | 24 (80) | 16 (59.3) | 40 (70.2) | |
| Male recipient with female donor | 2 | 4 | .41 | |
| ECOG performance status, N (%) | .51 | |||
| 0 | 4 (13.3) | 7 (25.9) | 11 (19.3) | |
| 1 | 18 (60) | 15 (55.6) | 32 (56.1) | |
| 2 | 7 (23.3) | 5 (18.5) | 12 (21.1) | |
| Disease transplanted | .97 | |||
| AML | 11 (36.7) | 10 (37) | 21 (36.8) | |
| Second Complete Remission | 1 (10) | 1 (4.8) | ||
| Induction failure | 8 (72.7) | 6 (60) | 14 (66.7) | |
| Relapsed | 2 (18.2) | 3 (30) | 5 (23.8) | |
| Untreated | 1 (9.1) | 1 (4.8) | ||
| AML ELN risk category, N (%) | ||||
| Intermediate | 5 (45.5) | 4 (40) | 9 (42.9) | |
| Adverse | 6 (54.5) | 6 (60) | 12 (57.1) | |
| MDS | 19 (63.3) | 17 (63) | 36 (63.2) | |
| Therapy-related MDS | 3 (15.8) | 4 (23.5) | 7 (19.4) | |
| IPSS-R risk | ||||
| Good | 10 (52.6) | 8 (47.1) | 18 (50) | |
| Intermediate | 3 (15.8) | 3 (17.6) | 6 (16.7) | |
| Poor | 4 (21.1) | 2 (11.8) | 6 (16.7) | |
| Very poor | 2 (10.5) | 4 (23.5) | 6 (16.7) | |
| TP53 mutated | ||||
| No | 14 (73.7) | 10 (58.8) | 28 (77.8) | |
| Yes | 2 (10.5) | 5 (29.4) | 7 (19.4) | |
| Not done | 3 (15.8) | 2 (11.8) | 5 (13.9) | |
| Cytoreductive therapy before HSCT, N (%) | ||||
| No | 5 (16.7) | 5 (18.5) | 10 (17.5) | |
| Yes | 25 (83.3) | 22 (81.5) | 47 (82.5) | |
| Marrow blasts at enrollment (%) | .28 | |||
| Median (range) | 13 (4, 60) | 11 (4, 58) | 12 (4, 60) | |
| Donor type | .37 | |||
| Matched unrelated | 24 (80) | 18 (66.7) | 42 (73.7) | |
| Matched sibling | 6 (20) | 9 (33.3) | 15 (26.3) | |
| CMV serostatus | .72 | |||
| R+/D+ | 4 (13.3) | 6 (22.2) | 10 (17.5) | |
| R+/D– | 9 (30) | 6 (22.2) | 15 (26.3) | |
| R–/D+ | 4 (13.3) | 5 (18.5) | 9 (15.8) | |
| R–/D– | 13 (43.4) | 10 (37) | 23 (40.4) | |
| Conditioning | .68 | |||
| MAC (myeloablative busulfan/ fludarabine) | 15 (50) | 15 (55.6) | 30 (52.6) | |
| RIC (Reduced intensity busulfan/fludarabine) | 15 (50) | 12 (44.4) | 27 (47.4) | |
| Graft source | 1 | |||
| Bone marrow | 2 (6.7) | 2 (7.4) | 4 (7) | |
| Peripheral blood | 28 (93.3) | 25 (92.6) | 53 (93) | |
| Characteristic . | GVAX (n = 30) . | Placebo (n = 27) . | All (N = 57) . | P . |
|---|---|---|---|---|
| Age, median (range) | 64 (27, 75) | 63 (35, 74) | 63 (27, 75) | .38 |
| Patient sex, N (%) | .6 | |||
| Female | 11 (36.7) | 12 (44.4) | 23 (40.4) | |
| Male | 19 (63.3) | 15 (55.6) | 34 (59.6) | |
| Donor age, median (range), y | 28 (19, 67) | 30 (19, 68) | 28 (19, 68) | .17 |
| Donor sex, N (%) | .15 | |||
| Female | 6 (20) | 11 (40.7) | 17 (29.8) | |
| Male | 24 (80) | 16 (59.3) | 40 (70.2) | |
| Male recipient with female donor | 2 | 4 | .41 | |
| ECOG performance status, N (%) | .51 | |||
| 0 | 4 (13.3) | 7 (25.9) | 11 (19.3) | |
| 1 | 18 (60) | 15 (55.6) | 32 (56.1) | |
| 2 | 7 (23.3) | 5 (18.5) | 12 (21.1) | |
| Disease transplanted | .97 | |||
| AML | 11 (36.7) | 10 (37) | 21 (36.8) | |
| Second Complete Remission | 1 (10) | 1 (4.8) | ||
| Induction failure | 8 (72.7) | 6 (60) | 14 (66.7) | |
| Relapsed | 2 (18.2) | 3 (30) | 5 (23.8) | |
| Untreated | 1 (9.1) | 1 (4.8) | ||
| AML ELN risk category, N (%) | ||||
| Intermediate | 5 (45.5) | 4 (40) | 9 (42.9) | |
| Adverse | 6 (54.5) | 6 (60) | 12 (57.1) | |
| MDS | 19 (63.3) | 17 (63) | 36 (63.2) | |
| Therapy-related MDS | 3 (15.8) | 4 (23.5) | 7 (19.4) | |
| IPSS-R risk | ||||
| Good | 10 (52.6) | 8 (47.1) | 18 (50) | |
| Intermediate | 3 (15.8) | 3 (17.6) | 6 (16.7) | |
| Poor | 4 (21.1) | 2 (11.8) | 6 (16.7) | |
| Very poor | 2 (10.5) | 4 (23.5) | 6 (16.7) | |
| TP53 mutated | ||||
| No | 14 (73.7) | 10 (58.8) | 28 (77.8) | |
| Yes | 2 (10.5) | 5 (29.4) | 7 (19.4) | |
| Not done | 3 (15.8) | 2 (11.8) | 5 (13.9) | |
| Cytoreductive therapy before HSCT, N (%) | ||||
| No | 5 (16.7) | 5 (18.5) | 10 (17.5) | |
| Yes | 25 (83.3) | 22 (81.5) | 47 (82.5) | |
| Marrow blasts at enrollment (%) | .28 | |||
| Median (range) | 13 (4, 60) | 11 (4, 58) | 12 (4, 60) | |
| Donor type | .37 | |||
| Matched unrelated | 24 (80) | 18 (66.7) | 42 (73.7) | |
| Matched sibling | 6 (20) | 9 (33.3) | 15 (26.3) | |
| CMV serostatus | .72 | |||
| R+/D+ | 4 (13.3) | 6 (22.2) | 10 (17.5) | |
| R+/D– | 9 (30) | 6 (22.2) | 15 (26.3) | |
| R–/D+ | 4 (13.3) | 5 (18.5) | 9 (15.8) | |
| R–/D– | 13 (43.4) | 10 (37) | 23 (40.4) | |
| Conditioning | .68 | |||
| MAC (myeloablative busulfan/ fludarabine) | 15 (50) | 15 (55.6) | 30 (52.6) | |
| RIC (Reduced intensity busulfan/fludarabine) | 15 (50) | 12 (44.4) | 27 (47.4) | |
| Graft source | 1 | |||
| Bone marrow | 2 (6.7) | 2 (7.4) | 4 (7) | |
| Peripheral blood | 28 (93.3) | 25 (92.6) | 53 (93) | |
ELN, European LeukemiaNet; IPSS-R, Revised International Prognostic Scoring System.