Characteristics of evaluable patients
| . | MA rhEPO from D28 . | Non-MA rhEPO from D28 . | Non-MA rhEPO from D0 . | Total . | ||||
|---|---|---|---|---|---|---|---|---|
| Stratification by conditioning and EPO initiation . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . |
| Number of patients | 19 | 15 | 18 | 19 | 25 | 23 | 62 | 57 |
| Age (mean ± SD) | 40 ± 13 | 40 ± 12 | 53 ± 11 | 55 ± 9 | 57 ± 10 | 55 ± 13 | 51 ± 13 | 51 ± 13 |
| Sex (female/male) | 6 / 13 | 8 / 7 | 7 / 11 | 8 / 11 | 10 / 15 | 11 / 12 | 23 / 39 | 27 / 30 |
| Body weight before transplantation, kg (mean ± SD) | 66 ± 19 | 65 ± 14 | 73 ± 13 | 72 ± 16 | 71 ± 14 | 70 ± 12 | 70 ± 15 | 70 ± 14 |
| Diagnosis (n) | ||||||||
| Acute myeloid leukemia/myelodysplasic syndrome | 12 | 7 | 6 | 6 | 7 | 16 | 25 | 29 |
| Acute lymphoid leukemia/lymphoblastic lymphoma | 2 | 3 | 0 | 0 | 0 | 0 | 2 | 3 |
| Non-Hodgkin’s lymphoma | 4 | 3 | 5 | 8 | 7 | 4 | 16 | 15 |
| Hodgkin’s lymphoma | 0 | 0 | 2 | 1 | 1 | 0 | 3 | 1 |
| Multiple myeloma | 0 | 1 | 4 | 3 | 8 | 3 | 12 | 7 |
| Other | 1 | 1 | 1 | 1 | 2 | 0 | 4 | 2 |
| Disease risk index | ||||||||
| 1 | 7 | 7 | 5 | 5 | 3 | 8 | 15 | 20 |
| 2 | 7 | 4 | 7 | 9 | 13 | 14 | 27 | 27 |
| 3 | 4 | 3 | 3 | 4 | 7 | 1 | 14 | 8 |
| 4 | 1 | 1 | 1 | 1 | 2 | 0 | 4 | 2 |
| Not known | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
| Status at transplantation | ||||||||
| First or second complete remission | 9 | 8 | 5 | 6 | 10 | 13 | 24 | 27 |
| First or second partial remission | 3 | 1 | 4 | 4 | 6 | 5 | 13 | 10 |
| Beyond second partial remission | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 3 |
| Refractory disease | 4 | 4 | 3 | 3 | 2 | 3 | 9 | 10 |
| Untreated disease | 2 | 0 | 4 | 1 | 1 | 0 | 7 | 1 |
| Untreated relapse | 0 | 0 | 1 | 4 | 6 | 1 | 7 | 5 |
| Nonmalignant disease | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Conditioning regimens | ||||||||
| MA | ||||||||
| AraC-Cy-TBI | 6 | 5 | 0 | 0 | 0 | 0 | 6 | 5 |
| AraC-Mel-TBI | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 |
| Cy-TBI | 4 | 5 | 0 | 0 | 0 | 0 | 4 | 5 |
| Mel-TBI | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Cy-ATG | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 1 |
| Other | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Non-MA | ||||||||
| Fluda-TBI 2Gy | 0 | 0 | 13 | 15 | 17 | 19 | 30 | 34 |
| Fluda-TBI 2x2Gy | 0 | 0 | 4 | 2 | 4 | 3 | 8 | 5 |
| TBI 2Gy | 0 | 0 | 1 | 2 | 3 | 0 | 4 | 2 |
| Fluda-Cy | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 |
| Prior HCT | ||||||||
| Autologous | 0 | 1 | 9 | 7 | 14 | 7 | 23 | 15 |
| MA allogeneic | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 |
| Non-MA allogeneic | 0 | 1 | 1 | 3 | 2 | 1 | 3 | 5 |
| Donor type | ||||||||
| HLA-identical sibling | 10 | 10 | 6 | 4 | 8 | 3 | 24 | 17 |
| Other related | 2 | 1 | 0 | 1 | 9 | 11 | 11 | 13 |
| HLA-identical unrelated | 3 | 1 | 3 | 9 | 0 | 0 | 6 | 10 |
| HLA-nonidentical unrelated | 4 | 3 | 9 | 5 | 8 | 9 | 21 | 17 |
| ABO compatibility | ||||||||
| Identical | 10 | 7 | 9 | 12 | 14 | 15 | 33 | 34 |
| Major mismatch | 5 | 3 | 5 | 6 | 5 | 3 | 15 | 12 |
| Major and minor mismatch | 1 | 2 | 2 | 0 | 1 | 3 | 4 | 5 |
| Minor mismatch | 3 | 3 | 2 | 1 | 5 | 2 | 10 | 6 |
| Graft manipulation | ||||||||
| None | 8 | 4 | 10 | 10 | 24 | 23 | 42 | 37 |
| CD34 selection | 7 | 8 | 0 | 0 | 0 | 0 | 7 | 8 |
| AC133 selection | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 |
| CD8 depletion | 0 | 0 | 8 | 9 | 1 | 0 | 9 | 9 |
| CMV status (donor/recipient) | ||||||||
| +/+ | 3 | 7 | 8 | 5 | 7 | 5 | 18 | 17 |
| +/− | 5 | 3 | 2 | 6 | 0 | 3 | 7 | 12 |
| −/+ | 5 | 2 | 2 | 7 | 9 | 11 | 16 | 20 |
| −/− | 6 | 3 | 6 | 1 | 9 | 4 | 21 | 8 |
| . | MA rhEPO from D28 . | Non-MA rhEPO from D28 . | Non-MA rhEPO from D0 . | Total . | ||||
|---|---|---|---|---|---|---|---|---|
| Stratification by conditioning and EPO initiation . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . | Arm 1 (control) . | Arm 2 (rhEPO) . |
| Number of patients | 19 | 15 | 18 | 19 | 25 | 23 | 62 | 57 |
| Age (mean ± SD) | 40 ± 13 | 40 ± 12 | 53 ± 11 | 55 ± 9 | 57 ± 10 | 55 ± 13 | 51 ± 13 | 51 ± 13 |
| Sex (female/male) | 6 / 13 | 8 / 7 | 7 / 11 | 8 / 11 | 10 / 15 | 11 / 12 | 23 / 39 | 27 / 30 |
| Body weight before transplantation, kg (mean ± SD) | 66 ± 19 | 65 ± 14 | 73 ± 13 | 72 ± 16 | 71 ± 14 | 70 ± 12 | 70 ± 15 | 70 ± 14 |
| Diagnosis (n) | ||||||||
| Acute myeloid leukemia/myelodysplasic syndrome | 12 | 7 | 6 | 6 | 7 | 16 | 25 | 29 |
| Acute lymphoid leukemia/lymphoblastic lymphoma | 2 | 3 | 0 | 0 | 0 | 0 | 2 | 3 |
| Non-Hodgkin’s lymphoma | 4 | 3 | 5 | 8 | 7 | 4 | 16 | 15 |
| Hodgkin’s lymphoma | 0 | 0 | 2 | 1 | 1 | 0 | 3 | 1 |
| Multiple myeloma | 0 | 1 | 4 | 3 | 8 | 3 | 12 | 7 |
| Other | 1 | 1 | 1 | 1 | 2 | 0 | 4 | 2 |
| Disease risk index | ||||||||
| 1 | 7 | 7 | 5 | 5 | 3 | 8 | 15 | 20 |
| 2 | 7 | 4 | 7 | 9 | 13 | 14 | 27 | 27 |
| 3 | 4 | 3 | 3 | 4 | 7 | 1 | 14 | 8 |
| 4 | 1 | 1 | 1 | 1 | 2 | 0 | 4 | 2 |
| Not known | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
| Status at transplantation | ||||||||
| First or second complete remission | 9 | 8 | 5 | 6 | 10 | 13 | 24 | 27 |
| First or second partial remission | 3 | 1 | 4 | 4 | 6 | 5 | 13 | 10 |
| Beyond second partial remission | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 3 |
| Refractory disease | 4 | 4 | 3 | 3 | 2 | 3 | 9 | 10 |
| Untreated disease | 2 | 0 | 4 | 1 | 1 | 0 | 7 | 1 |
| Untreated relapse | 0 | 0 | 1 | 4 | 6 | 1 | 7 | 5 |
| Nonmalignant disease | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Conditioning regimens | ||||||||
| MA | ||||||||
| AraC-Cy-TBI | 6 | 5 | 0 | 0 | 0 | 0 | 6 | 5 |
| AraC-Mel-TBI | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 |
| Cy-TBI | 4 | 5 | 0 | 0 | 0 | 0 | 4 | 5 |
| Mel-TBI | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Cy-ATG | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 1 |
| Other | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Non-MA | ||||||||
| Fluda-TBI 2Gy | 0 | 0 | 13 | 15 | 17 | 19 | 30 | 34 |
| Fluda-TBI 2x2Gy | 0 | 0 | 4 | 2 | 4 | 3 | 8 | 5 |
| TBI 2Gy | 0 | 0 | 1 | 2 | 3 | 0 | 4 | 2 |
| Fluda-Cy | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 |
| Prior HCT | ||||||||
| Autologous | 0 | 1 | 9 | 7 | 14 | 7 | 23 | 15 |
| MA allogeneic | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 |
| Non-MA allogeneic | 0 | 1 | 1 | 3 | 2 | 1 | 3 | 5 |
| Donor type | ||||||||
| HLA-identical sibling | 10 | 10 | 6 | 4 | 8 | 3 | 24 | 17 |
| Other related | 2 | 1 | 0 | 1 | 9 | 11 | 11 | 13 |
| HLA-identical unrelated | 3 | 1 | 3 | 9 | 0 | 0 | 6 | 10 |
| HLA-nonidentical unrelated | 4 | 3 | 9 | 5 | 8 | 9 | 21 | 17 |
| ABO compatibility | ||||||||
| Identical | 10 | 7 | 9 | 12 | 14 | 15 | 33 | 34 |
| Major mismatch | 5 | 3 | 5 | 6 | 5 | 3 | 15 | 12 |
| Major and minor mismatch | 1 | 2 | 2 | 0 | 1 | 3 | 4 | 5 |
| Minor mismatch | 3 | 3 | 2 | 1 | 5 | 2 | 10 | 6 |
| Graft manipulation | ||||||||
| None | 8 | 4 | 10 | 10 | 24 | 23 | 42 | 37 |
| CD34 selection | 7 | 8 | 0 | 0 | 0 | 0 | 7 | 8 |
| AC133 selection | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 |
| CD8 depletion | 0 | 0 | 8 | 9 | 1 | 0 | 9 | 9 |
| CMV status (donor/recipient) | ||||||||
| +/+ | 3 | 7 | 8 | 5 | 7 | 5 | 18 | 17 |
| +/− | 5 | 3 | 2 | 6 | 0 | 3 | 7 | 12 |
| −/+ | 5 | 2 | 2 | 7 | 9 | 11 | 16 | 20 |
| −/− | 6 | 3 | 6 | 1 | 9 | 4 | 21 | 8 |
AraC, cytarabine; ATG, antithymocyte globulin; Cy, cyclophosphamide; Fluda, fludarabine; Gy, Gray; Mel, melphalan; TBI, total body irradiation.