Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02104427 | PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients | PHASE2 | COMPLETED | 12 | — | — | Feb 1, 2015 | Nov 1, 2015 | Apr 19, 2021 | 2 | United States |
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...