Table 1.
Baseline Characteristics of the Study Populations Entering the Phase I and Phase II of the Study
| Characteristic | Phase I (N=12) | Phase II (N=16) | ||
|---|---|---|---|---|
| No of patients(%) | Median (range) | No of patients(%) | Median (range) | |
| Age, years | 57 (22–69) | 58 (46–72) | ||
| Sex: | ||||
| Female | 5 (41.7) | 6 (37.5) | ||
| Male | 7 (58.3) | 10 (62.5) | ||
| Type of Myelofibrosis: | ||||
| Primary | 11 (91.6) | 10 (62.5) | ||
| Post-PV | 1 (8.4) | 4 (25) | ||
| Post-ET | 0 | 2 (12.5) | ||
| Prior Treatment for Myelofibrosis | ||||
| Hydroxyurea | 8 (66.6) | 13 (81.2) | ||
| Splenectomy | 1 (8.4) | 2 (12.5) | ||
| Danazol | 1 (8.4) | 2 (12.5) | ||
| Thalidomide | 1 (8.4) | 2 (12.5) | ||
| Duration of the disease (months) | 44.5 (1–228) | 35 (1–156) | ||
| Transfusion dependent patients | 2 (16.6) | 3 (18.7) | ||
| Transfusion – independent patients with initial hemoglobin <10g/dL | 5 (41.7) | 5 (31.2) | ||
| White blood cell count (×109/L) | 7.9 (3.7–71.3) | 13.2 (1.7–71.3) | ||
| Myeloblasts in peripheral blood (%) | 2 (0–7) | 1 (0–7) | ||
| Immature myeloid cells (non-blasts) in peripheral blood(%) | 1 (0–12) | 3 (0–15) | ||
| Erythroblasts (%leukocytes) in peripheral blood | 3 (0–45) | 4 (0–45) | ||
| Platelet count(×109/L) | 302 (106–1066) | 285 (70–3405) | ||
| Spleen size below the costal margin, cm | 15 (2–20) | 15(2–25) | ||
| Dupriez prognostic score | ||||
| Score 0 | 4 (33.3) | 7 (43.8) | ||
| Score 1 | 6 (50) | 6 (37.5) | ||
| Score 2 | 2 (16.7) | 3 (18.7) | ||
| Serum lactate dehydrogenase(mU/mL) | 1486 (358–3024) | 1408 (489–2658) | ||
| Chromosomal abnormalities* | ||||
| Not available | 5 (41.7) | 7 (43.8) | ||
| No chromosomal abnormalities | 5 (41.7) | 4 (25) | ||
| Chromosomal abnormalities** | 2 (16.7)§ | 5 (31.2)§§ | ||
*
In all patients analysis of chromosomal abnormalities was performed on peripheral blood
§
del5, del7
§§
del20, t(x;20), del6/del14, del5, del7