Baseline characteristics
| . | N . | % . |
|---|---|---|
| Total | 35 | 100 |
| Median age, y (range) | 51 (22, 72) | |
| Patient sex | ||
| F | 17 | 48.6 |
| M | 18 | 51.4 |
| Patient-donor sex match | ||
| FF | 9 | 25.7 |
| FM | 7 | 20 |
| MF | 8 | 22.9 |
| MM | 11 | 31.4 |
| HLA typing (A, B, C, DRB1) at HSCT | ||
| Matched unrelated | 18 | 51.4 |
| Matched related | 14 | 40 |
| Mismatched related | 3 | 8.6 |
| Conditioning intensity at HSCT | ||
| MAC | 18 | 51.4 |
| RIC | 17 | 48.6 |
| Primary disease | ||
| Acute lymphoid leukemia | 3 | 8.6 |
| Acute myeloid leukemia | 9 | 25.7 |
| CLL/SLL/PLL | 4 | 11.4 |
| Chronic myeloid leukemia | 1 | 2.9 |
| Hodgkin lymphoma | 1 | 2.9 |
| Myelodyplastic syndromes (MDS) | 7 | 20 |
| MM/PCD | 1 | 2.9 |
| Myeloproliferative disorder (MPD) | 1 | 2.9 |
| Mixed MDS/MPD | 1 | 2.9 |
| Non-Hodgkin lymphoma | 6 | 17.1 |
| Other acute leukemia | 1 | 2.9 |
| Disease Risk Index (DRI) | ||
| Low | 7 | 20 |
| Intermediate | 17 | 48.6 |
| High | 10 | 28.6 |
| Very high | 1 | 2.9 |
| Graft source at HSCT | ||
| Bone marrow (BM) | 1 | 2.9 |
| Peripheral blood stem cell (PBSC) | 32 | 94.1 |
| BM + PBSC | 1 | 2.9 |
| Median no. of cGVHD sites (range) | 4 (1, 7) | |
| Global cGVHD severity (per NIH criteria) | ||
| Mild | 6 | 17.1 |
| Moderate | 22 | 62.7 |
| Severe | 7 | 20 |
| Median prednisone dose at baseline (range) | 20 (2.5, 50) | |
| Median no. of prior treatments* (range) | 2 (1, 4) | |
| Median time from HSCT to start of IL-2, d (range) | 616 (270, 2145) | |
| Median time from cGVHD to start of IL-2, d (range) | 317 (28, 1880) | |
| Median time from HSCT to cGVHD, d (range) | 266 (46, 996) | |
| Response at week 12 | ||
| Partial response | 20 | 57.1 |
| Stable disease (including minor response) | 10 | 28.6 |
| Progressive disease | 3 | 8.6 |
| Nonevaluable† | 2 | 5.7 |
| No. of patients initiating extended IL-2 treatment | 23 | 65.7 |
| . | N . | % . |
|---|---|---|
| Total | 35 | 100 |
| Median age, y (range) | 51 (22, 72) | |
| Patient sex | ||
| F | 17 | 48.6 |
| M | 18 | 51.4 |
| Patient-donor sex match | ||
| FF | 9 | 25.7 |
| FM | 7 | 20 |
| MF | 8 | 22.9 |
| MM | 11 | 31.4 |
| HLA typing (A, B, C, DRB1) at HSCT | ||
| Matched unrelated | 18 | 51.4 |
| Matched related | 14 | 40 |
| Mismatched related | 3 | 8.6 |
| Conditioning intensity at HSCT | ||
| MAC | 18 | 51.4 |
| RIC | 17 | 48.6 |
| Primary disease | ||
| Acute lymphoid leukemia | 3 | 8.6 |
| Acute myeloid leukemia | 9 | 25.7 |
| CLL/SLL/PLL | 4 | 11.4 |
| Chronic myeloid leukemia | 1 | 2.9 |
| Hodgkin lymphoma | 1 | 2.9 |
| Myelodyplastic syndromes (MDS) | 7 | 20 |
| MM/PCD | 1 | 2.9 |
| Myeloproliferative disorder (MPD) | 1 | 2.9 |
| Mixed MDS/MPD | 1 | 2.9 |
| Non-Hodgkin lymphoma | 6 | 17.1 |
| Other acute leukemia | 1 | 2.9 |
| Disease Risk Index (DRI) | ||
| Low | 7 | 20 |
| Intermediate | 17 | 48.6 |
| High | 10 | 28.6 |
| Very high | 1 | 2.9 |
| Graft source at HSCT | ||
| Bone marrow (BM) | 1 | 2.9 |
| Peripheral blood stem cell (PBSC) | 32 | 94.1 |
| BM + PBSC | 1 | 2.9 |
| Median no. of cGVHD sites (range) | 4 (1, 7) | |
| Global cGVHD severity (per NIH criteria) | ||
| Mild | 6 | 17.1 |
| Moderate | 22 | 62.7 |
| Severe | 7 | 20 |
| Median prednisone dose at baseline (range) | 20 (2.5, 50) | |
| Median no. of prior treatments* (range) | 2 (1, 4) | |
| Median time from HSCT to start of IL-2, d (range) | 616 (270, 2145) | |
| Median time from cGVHD to start of IL-2, d (range) | 317 (28, 1880) | |
| Median time from HSCT to cGVHD, d (range) | 266 (46, 996) | |
| Response at week 12 | ||
| Partial response | 20 | 57.1 |
| Stable disease (including minor response) | 10 | 28.6 |
| Progressive disease | 3 | 8.6 |
| Nonevaluable† | 2 | 5.7 |
| No. of patients initiating extended IL-2 treatment | 23 | 65.7 |
Patient, transplantation, and cGVHD characteristics of the phase 2 trial.
CLL, chronic lymphocytic leukemia; F, female; M, male; MAC, myeloablative conditioning; MM, multiple myeloma; PCD, plasma cell dyscrasia; PLL, prolymphocytic leukemia; RIC, reduced-intensity conditioning; SLL, small lymphocytic leukemia.
Concurrent immune-suppression therapies beside corticosteroids included tacrolimus (n = 17), sirolimus (n = 5), mycophenolate mofetil (n = 5).
Two patients received the treatment <6 weeks, thus were not evaluable for response.