Baseline characteristics of study sample, by dose cohort
| Characteristic . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| Median age (range), y | 22.0 (18-50) | 58.0 (19-72) | 55.0 (18-72) |
| Male | 1 (33.3) | 16 (76.2) | 17 (70.8) |
| Mean weight (SD), kg | 92.93 (25.66) | 89.96 (25.84) | 90.33 (25.27) |
| Baseline ECOG performance status | |||
| 0 | 2 (66.7) | 8 (38.1) | 10 (41.7) |
| 1 | 1 (33.3) | 12 (57.1) | 13 (54.2) |
| 2 | 0 (0) | 1 (4.8) | 1 (4.2) |
| Disease type | |||
| Myeloproliferative neoplasm | 0 (0) | 3 (14.3) | 3 (12.5) |
| Myelodysplastic/myeloproliferative neoplasm | 0 (0) | 3 (14.3) | 3 (12.5) |
| Myelodysplastic syndrome | 0 (0) | 2 (9.5) | 2 (8.3) |
| AML or related precursor neoplasm | 3 (100) | 6 (28.6) | 9 (37.5) |
| Precursor lymphoid neoplasm | 0 (0) | 5 (23.8) | 5 (20.8) |
| Precursor T-ALL/LBL | 0 (0) | 3 (14.3) | 3 (12.5) |
| Precursor B-ALL/LBL | 0 (0) | 2 (9.5) | 2 (8.3) |
| Other | 0 (0) | 2 (9.5) | 2 (8.3) |
| Conditioning regimen | |||
| Myeloablative, busulfan + fludarabine | 2 (66.7) | 5 (23.8) | 7 (29.2) |
| Myeloablative, cyclophosphamide + TBI | 1 (33.3) | 5 (23.8) | 6 (25.0) |
| Reduced-intensity, busulfan + fludarabine | 0 (0) | 6 (28.6) | 6 (25.0) |
| Reduced-intensity, fludarabine + melphalan | 0 (0) | 5 (23.8) | 5 (20.8) |
| Source of stem cells | |||
| Bone marrow | 3 (100) | 6 (28.6) | 9 (37.5) |
| Peripheral blood | 0 (0) | 15 (71.4) | 15 (62.5) |
| Donor-recipient sex match | |||
| Female-male/male-female | 2 (66.7) | 9 (42.9) | 11 (45.8) |
| Other | 1 (33.3) | 12 (57.1) | 13 (54.2) |
| Donor relationship to study participant | |||
| Related | 0 (0) | 4 (19.0) | 4 (16.7) |
| Unrelated | 3 (100) | 17 (81.0) | 20 (83.3) |
| HLA compatibility | |||
| Matched | 3 (100) | 20 (95.2) | 23 (95.8) |
| Mismatched | 0 (0) | 1 (4.8) | 1 (4.2) |
| Donor CMV IgG antibody | |||
| Positive | 0 (0) | 10 (47.6) | 10 (41.7) |
| Negative | 3 (100) | 11 (52.4) | 14 (58.3) |
| HCT comorbidity index | |||
| Yes | 2 (66.7) | 17 (81.0) | 19 (79.2) |
| <4 | 1 (33.3) | 13 (61.9) | 14 (58.3) |
| ≥4 | 1 (33.3) | 4 (19.0) | 5 (20.8) |
| No or unknown | 1 (33.3) | 4 (19.0) | 5 (20.8) |
| Characteristic . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| Median age (range), y | 22.0 (18-50) | 58.0 (19-72) | 55.0 (18-72) |
| Male | 1 (33.3) | 16 (76.2) | 17 (70.8) |
| Mean weight (SD), kg | 92.93 (25.66) | 89.96 (25.84) | 90.33 (25.27) |
| Baseline ECOG performance status | |||
| 0 | 2 (66.7) | 8 (38.1) | 10 (41.7) |
| 1 | 1 (33.3) | 12 (57.1) | 13 (54.2) |
| 2 | 0 (0) | 1 (4.8) | 1 (4.2) |
| Disease type | |||
| Myeloproliferative neoplasm | 0 (0) | 3 (14.3) | 3 (12.5) |
| Myelodysplastic/myeloproliferative neoplasm | 0 (0) | 3 (14.3) | 3 (12.5) |
| Myelodysplastic syndrome | 0 (0) | 2 (9.5) | 2 (8.3) |
| AML or related precursor neoplasm | 3 (100) | 6 (28.6) | 9 (37.5) |
| Precursor lymphoid neoplasm | 0 (0) | 5 (23.8) | 5 (20.8) |
| Precursor T-ALL/LBL | 0 (0) | 3 (14.3) | 3 (12.5) |
| Precursor B-ALL/LBL | 0 (0) | 2 (9.5) | 2 (8.3) |
| Other | 0 (0) | 2 (9.5) | 2 (8.3) |
| Conditioning regimen | |||
| Myeloablative, busulfan + fludarabine | 2 (66.7) | 5 (23.8) | 7 (29.2) |
| Myeloablative, cyclophosphamide + TBI | 1 (33.3) | 5 (23.8) | 6 (25.0) |
| Reduced-intensity, busulfan + fludarabine | 0 (0) | 6 (28.6) | 6 (25.0) |
| Reduced-intensity, fludarabine + melphalan | 0 (0) | 5 (23.8) | 5 (20.8) |
| Source of stem cells | |||
| Bone marrow | 3 (100) | 6 (28.6) | 9 (37.5) |
| Peripheral blood | 0 (0) | 15 (71.4) | 15 (62.5) |
| Donor-recipient sex match | |||
| Female-male/male-female | 2 (66.7) | 9 (42.9) | 11 (45.8) |
| Other | 1 (33.3) | 12 (57.1) | 13 (54.2) |
| Donor relationship to study participant | |||
| Related | 0 (0) | 4 (19.0) | 4 (16.7) |
| Unrelated | 3 (100) | 17 (81.0) | 20 (83.3) |
| HLA compatibility | |||
| Matched | 3 (100) | 20 (95.2) | 23 (95.8) |
| Mismatched | 0 (0) | 1 (4.8) | 1 (4.2) |
| Donor CMV IgG antibody | |||
| Positive | 0 (0) | 10 (47.6) | 10 (41.7) |
| Negative | 3 (100) | 11 (52.4) | 14 (58.3) |
| HCT comorbidity index | |||
| Yes | 2 (66.7) | 17 (81.0) | 19 (79.2) |
| <4 | 1 (33.3) | 13 (61.9) | 14 (58.3) |
| ≥4 | 1 (33.3) | 4 (19.0) | 5 (20.8) |
| No or unknown | 1 (33.3) | 4 (19.0) | 5 (20.8) |
Data are presented as n (%) unless otherwise stated.
ECOG, Eastern Cooperative Oncology Group; HCT, hematopoietic cell transplantation; IgG, immunoglobulin G; LBL, lymphoblastic lymphoma; SD, standard deviation; TBI, total body irradiation.