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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01767714 | Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation | PHASE3 | COMPLETED | 100 | — | — | Apr 1, 2013 | Nov 1, 2014 | Dec 9, 2014 | 16 | China |
| Arm | Type | Description |
|---|---|---|
| G-CSF + plerixafor | EXPERIMENTAL | Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses. |
| G-CSF + Placebo | PLACEBO_COMPARATOR | Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses. |
| Name | Type | Description |
|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF) | DRUG | 10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection |
| Plerixafor | DRUG | 0.24 mg/kg/day subcutaneous injection |
| Placebo | DRUG | 0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection |
Inclusion Criteria: * Has a biopsy-confirmed diagnosis of NHL * Is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy * Treatment with an autologous peripheral HSC transplant is pl...