Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TG-0054 combined with G-CSF · 1 trial · 3 indications
The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10\^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.
| Arm | Type | Description |
|---|---|---|
| TG-0054 combined with G-CSF | EXPERIMENTAL | 1\. G-CSF: 10 μg/kg/day, administrated via SC injections from Day 1 to Day 8; 2. TG-0054: 3.14 mg/kg, administrated via 15-min IV infusion from Day 5 to Day 9 as needed to reach the target collection goal |
| Name | Type | Description |
|---|---|---|
| TG-0054 combined with G-CSF | DRUG | - |
Inclusion Criteria: * Male or female 18 to 75 years of age inclusive; * Patients with confirmed pathology diagnosis of MM, NHL or HD; * Potential candidate for autologous stem cell transplantation at Investigator's discretion; * \> 4 weeks since last cycle of chemotherapy prior to the study drug ad...
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