Clinical studies of 2 forms of recombinant thrombopoietin as adjunct to induction/consolidation chemotherapy in patients with newly diagnosed acute myelogenous leukemia
| Form . | Investigator . | No. of patients . | Chemotherapy . | Dose (μg/kg) . | Route . | Induction . | Consolidation . | ||
|---|---|---|---|---|---|---|---|---|---|
| Dosing . | Outcome . | Dosing . | Outcome . | ||||||
| PEG-rHuMGDF | Archimbaud et al112 | PEG-rHuMGDF = 38 | Daunorubicin, cytarabine, etoposide | 2.5 or 5.0 | SC | Multiple or single | Dose-related increase in median platelet count | Multiple or single | Dose-related increase in remission median platelet count |
| Placebo = 12 | No difference between groups in time to platelet recovery or platelet transfusion requirements | No difference between groups in time to platelet recovery or platelet transfusion requirements | |||||||
| Schiffer et al114 | PEG-rHuMGDF = 24 | Daunorubicin, cytarabine +/− high-dose cytarabine | 2.5 or 5.0 | SC | Multiple | No difference between groups in time to platelet count ≥ 20 × 109/L or platelet transfusion requirements | Multiple | No difference between groups in time to platelet recovery to ≥ 20 × 109/L and ≥ 50 × 109/L or platelet transfusion requirements | |
| Placebo = 11 | |||||||||
| rhTPO | Cripe et al115 | rhTPO = 28 | Idarubicin, cytarabine | 2.5-5.0 | IV | Multiple | No difference between rhTPO and historical controls in time to platelet count ≥ 20 × 109/L or ≥ 50 × 109/L | NA | NA |
| Form . | Investigator . | No. of patients . | Chemotherapy . | Dose (μg/kg) . | Route . | Induction . | Consolidation . | ||
|---|---|---|---|---|---|---|---|---|---|
| Dosing . | Outcome . | Dosing . | Outcome . | ||||||
| PEG-rHuMGDF | Archimbaud et al112 | PEG-rHuMGDF = 38 | Daunorubicin, cytarabine, etoposide | 2.5 or 5.0 | SC | Multiple or single | Dose-related increase in median platelet count | Multiple or single | Dose-related increase in remission median platelet count |
| Placebo = 12 | No difference between groups in time to platelet recovery or platelet transfusion requirements | No difference between groups in time to platelet recovery or platelet transfusion requirements | |||||||
| Schiffer et al114 | PEG-rHuMGDF = 24 | Daunorubicin, cytarabine +/− high-dose cytarabine | 2.5 or 5.0 | SC | Multiple | No difference between groups in time to platelet count ≥ 20 × 109/L or platelet transfusion requirements | Multiple | No difference between groups in time to platelet recovery to ≥ 20 × 109/L and ≥ 50 × 109/L or platelet transfusion requirements | |
| Placebo = 11 | |||||||||
| rhTPO | Cripe et al115 | rhTPO = 28 | Idarubicin, cytarabine | 2.5-5.0 | IV | Multiple | No difference between rhTPO and historical controls in time to platelet count ≥ 20 × 109/L or ≥ 50 × 109/L | NA | NA |
NA indicates not applicable; PEG-rHuMGDF, pegylated recombinant human megakaryocyte growth and development factor; rhTPO, recombinant human thrombopoietin; SC, subcutaneous; and IV, intravenous.