Clinical studies of 2 forms of recombinant thrombopoietin in patients receiving myeloablative chemotherapy followed by stem cell transplantation
| Form . | Investigator . | No. of patients . | Chemotherapy . | Dose (μg/kg) . | Route . | Stem cell mobilization . | Stem cell engraftment . | ||
|---|---|---|---|---|---|---|---|---|---|
| Dosing . | Outcome . | Dosing . | Outcome . | ||||||
| PEG-rHuMGDF | Glaspy et al116 | PEG-rHuMGDF = 39 | STAMP (high-dose) | 1, 3, 10, or 30 | SC | NA | NA | Multiple | Dose-related increase in median platelet count with PEG-rHuMGDF |
| Placebo = 14 | No difference between groups in time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||||||||
| Bolwell et al117 | PEG-rHuMGDF = 36 | STAMP I | 1.0, 2.5, 5.0, 7.5, or 10.0 | SC | NA | NA | Multiple (until platelet recovery ≥ 50 × 109/L) | Dose-related increase in platelet counts with PEG-rHuMGDF as compared with placebo | |
| Placebo = 11 | No difference between groups in time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||||||||
| Beveridge et al118 | PEG-rHuMGDF = 40 Placebo = 10 | STAMP V | 5 or 10.0 | SC | NA | NA | Multiple (until platelet recovery ≥ 25 × 109/L) | No difference between groups in time to platelet recovery, severe thrombocytopenia, or platelet transfusion requirements | |
| rhTPO | Nash et al120 | rhTPO = 38 with delayed platelet recovery after stem cell transplantation | NA | 0.6-2.4 | IV | NA | NA | Single and multiple until platelet recovery ≥ 20 × 109/L | No effect on time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements |
| Somlo et al121 | rhTPO plus G-CSF = 26 G-CSF alone = 20 | Cisplatin, etoposide, cyclophosphamide | 0.6-2.4 | IV | Single and multiple | Increased CD34+ cell yields with rhTPO plus G-CSF as compared with G-CSF alone | NA | Reduced time to platelet recovery and platelet transfusion requirements with rhTPO plus G-CSF-mobilized cells | |
| Linker et al123 | rhTPO plus G-CSF = 101 G-CSF alone = 28 | 1.5 | IV | Single or multiple | Increased CD34+ cell number per apheresis and number of patients reaching minimum graft (CD34+ > 2 × 106/kg) with rhTPO plus G-CSF as compared with G-CSF alone | Single or multiple | No effect on time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||
| Form . | Investigator . | No. of patients . | Chemotherapy . | Dose (μg/kg) . | Route . | Stem cell mobilization . | Stem cell engraftment . | ||
|---|---|---|---|---|---|---|---|---|---|
| Dosing . | Outcome . | Dosing . | Outcome . | ||||||
| PEG-rHuMGDF | Glaspy et al116 | PEG-rHuMGDF = 39 | STAMP (high-dose) | 1, 3, 10, or 30 | SC | NA | NA | Multiple | Dose-related increase in median platelet count with PEG-rHuMGDF |
| Placebo = 14 | No difference between groups in time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||||||||
| Bolwell et al117 | PEG-rHuMGDF = 36 | STAMP I | 1.0, 2.5, 5.0, 7.5, or 10.0 | SC | NA | NA | Multiple (until platelet recovery ≥ 50 × 109/L) | Dose-related increase in platelet counts with PEG-rHuMGDF as compared with placebo | |
| Placebo = 11 | No difference between groups in time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||||||||
| Beveridge et al118 | PEG-rHuMGDF = 40 Placebo = 10 | STAMP V | 5 or 10.0 | SC | NA | NA | Multiple (until platelet recovery ≥ 25 × 109/L) | No difference between groups in time to platelet recovery, severe thrombocytopenia, or platelet transfusion requirements | |
| rhTPO | Nash et al120 | rhTPO = 38 with delayed platelet recovery after stem cell transplantation | NA | 0.6-2.4 | IV | NA | NA | Single and multiple until platelet recovery ≥ 20 × 109/L | No effect on time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements |
| Somlo et al121 | rhTPO plus G-CSF = 26 G-CSF alone = 20 | Cisplatin, etoposide, cyclophosphamide | 0.6-2.4 | IV | Single and multiple | Increased CD34+ cell yields with rhTPO plus G-CSF as compared with G-CSF alone | NA | Reduced time to platelet recovery and platelet transfusion requirements with rhTPO plus G-CSF-mobilized cells | |
| Linker et al123 | rhTPO plus G-CSF = 101 G-CSF alone = 28 | 1.5 | IV | Single or multiple | Increased CD34+ cell number per apheresis and number of patients reaching minimum graft (CD34+ > 2 × 106/kg) with rhTPO plus G-CSF as compared with G-CSF alone | Single or multiple | No effect on time to platelet recovery to ≥ 20 × 109/L or platelet transfusion requirements | ||
G-CSF indicates granulocyte colony-stimulating factor; NA, not applicable; PEG-rHuMGDF, pegylated recombinant human megakaryocyte growth and development factor; rhTPO, recombinant human thrombopoietin; STAMP, solid tumor autologous marrow program.