Table 1.
Patient baseline characteristics
| Characteristic (n, % unless noted otherwise) | All, N = 83 | AC, n = 44 | TMS, n = 39 | P value |
|---|---|---|---|---|
| Age at transplant, median (range), y | 50.3 (34.8-60.9) | 51.3 (22.2-69.9) | 49.5 (20.9-71.1) | .87 |
| Sex | .68 | |||
| Male | 53 (64) | 29 (66) | 24 (62) | |
| Female | 30 (36) | 15 (34) | 15 (38) | |
| Ethnicity | .95 | |||
| Asian | 3 (4) | 1 (2) | 2 (5) | |
| Black | 7 (8) | 4 (9) | 3 (8) | |
| Hispanic | 4 (5) | 2 (5) | 2 (5) | |
| White | 68 (82) | 36 (82) | 32 (82) | |
| Other | 1 (1) | 1 (2) | 0 | |
| Disease | .74 | |||
| ALL | 4 (5) | 2 (5) | 2 (5) | |
| AML | 5 (6) | 2 (5) | 3 (8) | |
| MDS | 5 (6) | 3 (7) | 2 (5) | |
| CLL | 18 (22) | 9 (20) | 9 (23) | |
| CML | 3 (4) | 0 | 3 (8) | |
| Hodgkin lymphoma | 8 (10) | 5 (11) | 3 (8) | |
| Non-Hodgkin lymphoma | 29 (35) | 16 (36) | 13 (33) | |
| Other | 11 (13) | 7 (16) | 4 (10) | |
| Number of prior treatment regimens | .016 | |||
| 0-2 | 39 (47) | 15 (34) | 24 (62) | |
| 3-5 | 32 (39) | 19 (43) | 13 (33) | |
| ≥6 | 12 (14) | 10 (23) | 2 (5) | |
| Prior transplants | .19∗ | |||
| Yes | ||||
| Autologous | 15 (18) | 9 (20) | 6 (15) | |
| Allogeneic | 1 (1) | 1 (2) | 0 | |
| Syngeneic | 1 (1) | 1 (2) | 0 | |
| Autologous and allogeneic | 1 (1) | 1 (2) | 0 | |
| No | 65 (79) | 32 | 33 | |
| Disease status at time of transplant | .69† | |||
| No disease | 29 (35) | 16 (33) | 13 (33) | |
| Active | 38 (45) | 21 (48) | 17 (44) | |
| MRD | 13 (16) | 5 (11) | 8 (21) | |
| Not evaluable | 3 (4) | 2 (5) | 1 (2) | |
| Disease chemotherapy sensitivity | .51‡ | |||
| Chemotherapy-sensitive | 49 (59) | 27 (61) | 22 (56) | |
| Chemotherapy-resistant | 30 (36) | 14 (32) | 16 (41) | |
| Not evaluable | 4 (5) | 3 (7) | 1 (2) | |
| HLA match | 1.00 | |||
| 7/8 | 17 (20) | 9 (20) | 8 (21) | |
| 8/8 | 66 (80) | 35 (80) | 31 (79) | |
| Cycles of induction chemotherapy | .52§ | |||
| None | 32 (39) | 17 (39) | 15 (39) | |
| EPOCH-F(R) | 37 (45) | 21 (48) | 16 (41) | |
| Cycles (median, range) | 2 (1-3) | 2 (1-3) | 1.5 (1-3) | |
| FLAG | 13 (16) | 5 (11) | 8 (21) | |
| Cycles (median, range) | 1 (1-3) | 1 (1-2) | 1.5 (1-3) | |
| Pentostatin/cytoxan | 1 (1) | 1 (2) | 0 | |
| Baseline CD4 count∗ (median, range), ×109/L | 86 (6-520) | 86 (10-388) | 82 (6-520) | .75 |
| Infusion cell dose, median (range) | ||||
| CD34+, ×106 cells per kg | 7.15 (2.03-11.1) | 7.46 (4.09-10) | 6.4 (2.03-11.1) | .034 |
| CD3+, ×108 cells per kg | 2.40 (0.80-8.10) | 2.29 (1.07-5.32) | 2.44 (0.80-8.10) | .75 |
| CMV serology | .54‖ | |||
| Both seropositive | 35 (42) | 19 (43) | 16 (41) | |
| Both seronegative | 25 (30) | 13 (30) | 12 (31) | |
| Seronegative donor, seropositive recipient | 12 (14) | 8 (18) | 4 (10) | |
| Seropositive donor, seronegative recipient | 11 (13) | 4 (9) | 7 (18) | |
| Donor and recipient sex | .35¶ | |||
| Same sex | 49 (59) | 29 (66) | 20 (51) | |
| Female donor, male recipient | 13 (16) | 5 (11) | 8 (21) | |
| Male donor, female recipient | 21 (25) | 10 (23) | 11 (28) | |
| ABO mismatch | .93 | |||
| None | 47 (57) | 26 (59) | 21 (54) | |
| Major | 12 (14) | 6 (14) | 6 (15) | |
| Minor | 17 (20) | 9 (20) | 8 (21) | |
| Bidirectional | 7 (8) | 3 (7) | 4 (10) | |
| HCT-CI score50 | .86 | |||
| Median (range) | 3 (0-7) | 3 (0-6) | 2 (0-7) | |
| 0 | 18 (22) | 11 (25) | 7 (18) | |
| 1 | 7 (8) | 3 (7) | 4 (10) | |
| 2 | 16 (19) | 7 (16) | 9 (23) | |
| 3+ | 42 (51) | 23 (52) | 19 (49) | |
| Karnofsky performance status | .71 | |||
| 60-80 | 16 (19) | 11 (25) | 5 (13) | |
| 90 | 54 (65) | 25 (57) | 29 (74) | |
| 100 | 13 (16) | 8 (18) | 5 (13) | |
| Kahl relapse risk51 | .37 | |||
| Low | 27 (32) | 13 (30) | 14 (36) | |
| Intermediate/standard | 23 (28) | 11 (25) | 12 (31) | |
| High | 33 (40) | 20 (45) | 13 (33) | |
Continuous parameters were compared between arms using a t test, and categorical parameters were compared using a χ2 test.
Boldface is if the p-value is significant.
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; CML, chronic myelogenous leukemia; EPOCH-F, Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, Fludarabine; FLAG, Fludarabine, Cytarabine, Filgrastim; HCT-CI, hematopoietic cell transplant comorbidity index; MDS, myelodysplastic syndrome.
Comparison of prior transplant vs no prior transplant by arm.
Comparison includes “not evaluable”; P = .54, if “not evaluable” excluded.
Comparison includes “not evaluable”; P = .47, if “not evaluable” excluded.
Comparison of no induction chemotherapy vs EPOCH-F(R) vs FLAG.
Global P value; P = .93 for match vs mismatch.
Global P value; P = .18 for match vs mismatch; P = .25 for female donor, male recipient vs other.