Patient demographics in ITT patient population
| . | SoC+ECP (n = 29) . | SoC (n = 24) . | Overall (n = 53) . |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 21 (72.4) | 14 (58.3) | 35 (66.0) |
| Female | 8 (27.6) | 10 (41.7) | 18 (34.0) |
| Median age (range), y | 51.0 (23-72) | 52.5 (24-68) | 52.0 (23-72) |
| ECOG PS, n (%) | |||
| 0 | 11 (37.9) | 7 (29.2) | 18 (34.0) |
| 1 | 16 (55.2) | 14 (58.3) | 30 (56.6) |
| 2 | 2 (6.9) | 3 (12.5) | 5 (9.4) |
| Primary disease diagnosis, n (%) | |||
| MM | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| MDS | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| NHL | 3 (10.3) | 0 (0.0) | 3 (5.7) |
| ALL | 4 (13.8) | 1 (4.2) | 5 (9.4) |
| AML | 15 (51.7) | 18 (75.0) | 33 (62.3) |
| CLL | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| Other | 1 (3.4) | 2 (8.3) | 3 (5.7) |
| Months from onset of primary disease, mean (SD)* | 27.1 (27.5) | 34.2 (42.3) | 30.3 (34.8) |
| Donor, n (%)† | |||
| HLA-matched relative | 17 (58.6) | 13 (54.2) | 30 (56.6) |
| HLA-mismatched relative (1 Ag) | 1 (3.4) | 0 (0.0) | 1 (1.9) |
| Haploidentical relative | 1 (3.4) | 1 (4.2) | 2 (3.8) |
| Matched unrelated donor | 10 (34.5) | 10 (41.7) | 20 (37.7) |
| Mismatched unrelated donor | 4 (13.8) | 2 (8.3) | 6 (11.3) |
| Stem cell source, n (%) | |||
| Peripheral blood stem cells | 25 (86.2) | 22 (91.7) | 47 (88.7) |
| Bone marrow | 4 (13.8) | 2 (8.3) | 6 (11.3) |
| Months from transplant to first symptoms of cGVHD, mean (SD)* | 6.8 (4.7) | 9.0 (6.0) | 7.8 (5.4) |
| Severity of cGVHD, n (%) | |||
| Moderate | 17 (58.6) | 11 (45.8) | 28 (52.8) |
| Severe | 12 (41.4) | 13 (54.2) | 25 (47.2) |
| Platelet count, n (%) | |||
| <100 × 109/µL (high risk) | 26 (89.7) | 21 (87.5) | 47 (88.7) |
| ≥100 × 109/L (low risk) | 3 (10.3) | 3 (12.5) | 6 (11.3) |
| Organs involved in cGVHD, n (%) | |||
| Skin | 15 (51.7) | 12 (50.0) | 27 (50.9) |
| Liver | 4 (13.8) | 1 (4.2) | 5 (9.4) |
| GI tract | 7 (24.1) | 3 (12.5) | 10 (18.9) |
| Other | 5 (17.2) | 0 (0.0) | 5 (9.4) |
| cGVHD onset type, n (%) | |||
| De novo | 14 (48.3) | 14 (58.3) | 28 (52.8) |
| Progressive | 6 (20.7) | 1 (4.2) | 7 (13.2) |
| Quiescent | 9 (31.0) | 9 (37.5) | 18 (34.0) |
| . | SoC+ECP (n = 29) . | SoC (n = 24) . | Overall (n = 53) . |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 21 (72.4) | 14 (58.3) | 35 (66.0) |
| Female | 8 (27.6) | 10 (41.7) | 18 (34.0) |
| Median age (range), y | 51.0 (23-72) | 52.5 (24-68) | 52.0 (23-72) |
| ECOG PS, n (%) | |||
| 0 | 11 (37.9) | 7 (29.2) | 18 (34.0) |
| 1 | 16 (55.2) | 14 (58.3) | 30 (56.6) |
| 2 | 2 (6.9) | 3 (12.5) | 5 (9.4) |
| Primary disease diagnosis, n (%) | |||
| MM | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| MDS | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| NHL | 3 (10.3) | 0 (0.0) | 3 (5.7) |
| ALL | 4 (13.8) | 1 (4.2) | 5 (9.4) |
| AML | 15 (51.7) | 18 (75.0) | 33 (62.3) |
| CLL | 2 (6.9) | 1 (4.2) | 3 (5.7) |
| Other | 1 (3.4) | 2 (8.3) | 3 (5.7) |
| Months from onset of primary disease, mean (SD)* | 27.1 (27.5) | 34.2 (42.3) | 30.3 (34.8) |
| Donor, n (%)† | |||
| HLA-matched relative | 17 (58.6) | 13 (54.2) | 30 (56.6) |
| HLA-mismatched relative (1 Ag) | 1 (3.4) | 0 (0.0) | 1 (1.9) |
| Haploidentical relative | 1 (3.4) | 1 (4.2) | 2 (3.8) |
| Matched unrelated donor | 10 (34.5) | 10 (41.7) | 20 (37.7) |
| Mismatched unrelated donor | 4 (13.8) | 2 (8.3) | 6 (11.3) |
| Stem cell source, n (%) | |||
| Peripheral blood stem cells | 25 (86.2) | 22 (91.7) | 47 (88.7) |
| Bone marrow | 4 (13.8) | 2 (8.3) | 6 (11.3) |
| Months from transplant to first symptoms of cGVHD, mean (SD)* | 6.8 (4.7) | 9.0 (6.0) | 7.8 (5.4) |
| Severity of cGVHD, n (%) | |||
| Moderate | 17 (58.6) | 11 (45.8) | 28 (52.8) |
| Severe | 12 (41.4) | 13 (54.2) | 25 (47.2) |
| Platelet count, n (%) | |||
| <100 × 109/µL (high risk) | 26 (89.7) | 21 (87.5) | 47 (88.7) |
| ≥100 × 109/L (low risk) | 3 (10.3) | 3 (12.5) | 6 (11.3) |
| Organs involved in cGVHD, n (%) | |||
| Skin | 15 (51.7) | 12 (50.0) | 27 (50.9) |
| Liver | 4 (13.8) | 1 (4.2) | 5 (9.4) |
| GI tract | 7 (24.1) | 3 (12.5) | 10 (18.9) |
| Other | 5 (17.2) | 0 (0.0) | 5 (9.4) |
| cGVHD onset type, n (%) | |||
| De novo | 14 (48.3) | 14 (58.3) | 28 (52.8) |
| Progressive | 6 (20.7) | 1 (4.2) | 7 (13.2) |
| Quiescent | 9 (31.0) | 9 (37.5) | 18 (34.0) |
Ag, antigen; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; CLL, chronic lymphocytic leukemia; ECOG, Eastern Cooperative Oncology Group; GI, gastrointestinal; MDS, myelodysplastic syndrome; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; PS, performance status.
Time interval measured in months was calculated as the number of days/30.44.
More than 1 type of donor match was recorded for some patients.