Table 1.
Demographic and clinical characteristics of the participants.
| Characteristic | <4-month cohort | 4–12-month cohort | p-valued | Overall |
|---|---|---|---|---|
| No. of patients | 76 | 99 | 175 | |
| Median duration of follow up (months) | 8.06 (7.07–8.72) | 7.76 (7.11–8.29) | 0.62 | 7.86 (7.07–8.39) |
| Age at HCT, years - no. (%) | ||||
| Median (range) | 58.3 (9.3–75.4) | 58.7 (10.4–76.7) | 0.85 | 58.3 (9.3–76.7) |
| <18 | 4 (5) | 4 (4) | 8 (5) | |
| 18–29 | 6 (8) | 8 (8) | 14 (8) | |
| 30–39 | 2 (3) | 11 (11) | 13 (7) | |
| 40–49 | 11 (14) | 13 (13) | 24 (14) | |
| 50–59 | 20 (26) | 17 (17) | 37 (21) | |
| 60–69 | 27 (36) | 35 (35) | 62 (35) | |
| ≥70 | 6 (8) | 11 (11) | 17 (10) | |
| Sex - no. (%) | 1.00 | |||
| Female | 35 (46) | 46 (46) | 81 (46) | |
| Male | 41 (54) | 53 (54) | 94 (54) | |
| Hispanic or Latinx ethnicity- no. (%) | 0.47 | |||
| Yes | 2 (3) | 6 (6) | 8 (5) | |
| No | 72 (94) | 92 (93) | 163 (94) | |
| Unknown/Not reported | 2 (3) | 1 (1) | 3 (2) | |
| Race or Ethnic Group other than Hispanic or Latinx - no. (%) | 0.87 | |||
| White | 61 (85) | 78 (85) | 139 (85) | |
| Black | 5 (7) | 6 (7) | 11 (7) | |
| Asian | 4 (6) | 6 (7) | 10 (6) | |
| More than one race | 2 (3) | 1 (1) | 3 (2) | |
| Unknown/Not reported | 2 | 2 | 4 | |
| Underlying Diseasea - no. (%) | 0.21 | |||
| AML/MDS/MPN | 54 (71) | 64 (65) | 118 (67) | |
| ALL/other leukemia/aplastic anemia | 12 (16) | 26 (26) | 38 (22) | |
| Others | 10 (13) | 9 (9) | 19 (11) | |
| Date of HCT - no. (%) | <0.01 | |||
| May, 2020–December, 2020 | 0 (0) | 22 (22) | 22 (13) | |
| January, 2021–March, 2021 | 15 (20) | 35 (35) | 50 (29) | |
| April, 2021–June, 2021 | 40 (53) | 35 (35) | 75 (43) | |
| July, 2021–August, 2021 | 21 (28) | 7 (7) | 28 (16) | |
| Number of enrolling centers | 16 | 21 | 25 | |
| Graft source - no. (%) | <0.01 | |||
| Bone marrow | 4 (5) | 16 (16) | 20 (11) | |
| Peripheral blood | 72 (95) | 79 (80) | 151 (86) | |
| Cord blood | 0 (0) | 4 (4) | 4 (2) | |
| Donor and HLA match - no. (%) | 0.24 | |||
| Matched related | 19 (25) | 14 (14) | 33 (19) | |
| Matched unrelated | 33 (43) | 42 (42) | 75 (43) | |
| Mismatched related | 17 (22) | 31 (31) | 48 (27) | |
| Mismatched unrelated | 7 (9) | 12 (12) | 19 (11) | |
| Conditioning intensity - no. (%) | 0.85 | |||
| Myeloablative | 34 (45) | 40 (40) | 74 (42) | |
| Reduced intensity | 26 (34) | 37 (37) | 63 (36) | |
| Non-myeloablative or none | 16 (21) | 22 (22) | 38 (22) | |
| GVHD prophylaxisb,c - no. (%) | 0.87 | |||
| Post-HCT cyclophosphamide regimen | 29 (38) | 42 (42) | 71 (41) | |
| Non-post-HCT cyclophosphamide regimen | 45 (59) | 55 (56) | 100 (57) | |
| Unknown/Not reported | 2 (3) | 2 (2) | 4 (2) | |
| Acute GVHD prior to baseline sample - no. (%) | 0.08 | |||
| No | 56 (74) | 60 (61) | 116 (66) | |
| Yes | 20 (26) | 39 (39) | 59 (34) | |
| Chronic GVHD prior to baseline sample - no. (%) | <0.01 | |||
| No | 74 (97) | 79 (80) | 153 (87) | |
| Yes | 2 (3) | 20 (20) | 22 (13) | |
| Immunosuppressive medications in useb,c - no. (%) | ||||
| Pre-V1 | 65 (86) | 73 (74) | 0.06 | 138 (79) |
| Post-V1 | 64 (84) | 67 (68) | 0.01 | 131 (75) |
| Post-V2 | 59 (78) | 60 (61) | 0.02 | 119 (68) |
| Post-V3 | 36 (47) | 35 (35) | 0.12 | 71 (41) |
| End-of-study | 27 (36) | 37 (37) | 0.87 | 64 (37) |
| Absolute lymphocyte count (cells/mm3) at baseline, median (IQR) | 600 (400–800) | 700 (500–1300) | <0.01 | 700 (400–1100) |
| Absolute CD19+ B-cell count at baseline | 0.67 | |||
| Number of participants tested | 59 | 68 | 127 | |
| Median (IQR), cells/mm3 | 92 (38–169) | 87 (53–198) | 92 (42–183) | |
| Absolute CD4+ T-cell count at baseline | <0.01 | |||
| Number of participants tested | 59 | 68 | 127 | |
| Median (IQR), cells/mm3 | 56 (26–111) | 110 (40–262) | 78 (34–159) |
Percentages may not total 100 because of rounding. HCT indicates hematopoietic cell transplant; IQR, interquartile range; AML, acute myelogenous leukemia; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; ALL, acute lymphoblastic leukemia; HLA, human leukocyte antigen; GVHD, graft-versus-host disease.
The underlying disease ‘Others’ category consisted of non-Hodgkin lymphoma, Hodgkin lymphoma, sickle cell disease, and congenital immunodeficiencies or inborn errors of metabolism.
T-cell depleting agents were administered in 8 (11%) participants in the <4-month-cohort and 18 (18%) of participants in the 4-12-month cohort.
See Table S1 for details.
Calculated by a Fisher exact test or Kruskal–Wallis test as appropriate.