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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01458288 | A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease | PHASE2 | COMPLETED | 12 | — | — | Oct 1, 2012 | Jul 1, 2013 | Apr 19, 2021 | 1 | United States |
| NCT01018979 | Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients | PHASE2 | COMPLETED | 19 | — | — | Feb 1, 2010 | Oct 1, 2011 | May 11, 2021 | 6 | Taiwan |
Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD). Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
| Arm | Type | Description |
|---|---|---|
| TG-0054 (3.14 mg/kg) | EXPERIMENTAL | TG-0054 (3.14 mg/kg) |
| TG-0054 (2.24 mg/kg) | EXPERIMENTAL | TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Name | Type | Description |
|---|---|---|
| TG-0054 | DRUG | 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions) |
| TG-0054 (2.24 mg/kg) | DRUG | TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| TG-0054 (3.14 mg/kg) | DRUG | TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
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 admin...