Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plerixafor · 10 trials · 23 indications
Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.
Peripheral blood parameters
Peripheral blood parameters
Peripheral blood parameters
Peripheral blood parameters
Apheresis product parameters
Apheresis product parameters
Determining the causality of adverse events (AEs) and serious adverse events (SAEs)
leukocytes \> 500/ul on 2 consecutive days
platelet \> 20,000/ul on 2 consecutive days
Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.
Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.
| Arm | Type | Description |
|---|---|---|
| Related donors receiving plerixafor | EXPERIMENTAL | Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent. Eligible donors determined according to institutional standards * 18-65 years of age * 6/6 HLA-matched sibling * Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor * Serum creatinine \<1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) \>50 mL/min Treatment Description: * Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later. * Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is \> 4.0 x 106/kg with a minimum of \> 2.0 x 106/kg. |
| Recipients, myeloablative regimen | NO_INTERVENTION | Patients undergoing conditioning under a myeloablative regimen Myeloablative (one of four general regimens): Busulfan (\> 9 mg/kg po or iv total) with fludarabine Busulfan (\> 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (\> 1000 cGy) plus etoposide Total body irradiation (\> 500 cGy) plus cyclophosphamide |
| Recipients, reduced intensity conditioning regimen. | NO_INTERVENTION | Patients undergoing conditioning using a reduced intensity conditioning regimen. Reduced Intensity (one of three general regimens): Busulfan (\< 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (\> 2000 mg/m2 total) |
| G-CSF alone | ACTIVE_COMPARATOR | Patients will receive G-CSF for 5 consecutive days |
| G-CSF plus plerixafor | EXPERIMENTAL | Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF |
| AMD3100 added to a G-CSF Mobilisation regimen | EXPERIMENTAL | AMD3100 added to a G-CSF Mobilisation regimen |
| G-CSF plus placebo | ACTIVE_COMPARATOR | G-CSF plus placebo |
| Plerixafor (Mozobil) | OTHER | Plerixafor (Mozobil), continuous 7 day IV infusion. Starting at a dose of 20 ug/kg/hr, and subsequent dose levels of 40, 80 and 120 ug/kg/hr. |
| Plerixafor 160 μg/kg | EXPERIMENTAL | Patients will receive subcutaneous (SC) injection of 160 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
| Plerixafor 240 μg/kg | EXPERIMENTAL | Patients will receive subcutaneous (SC) injection of 240 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
| Plerixafor 320 μg/kg | EXPERIMENTAL | Patients will receive subcutaneous (SC) injection of 320 μg/kg plerixafor in addition to their standard mobilization regimen. Each dose of plerixafor will be administered in the evening 9 to 11 hours prior to apheresis (up to a maximum of 5 apheresis sessions). |
| Transplant Recipients | EXPERIMENTAL | Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. |
| plerixafor | EXPERIMENTAL | Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg) |
| Placebo | PLACEBO_COMPARATOR | - |
| Normal renal function | ACTIVE_COMPARATOR | Participants with normal renal function (creatinine clearance (CLcr) \> 90 ml/min) who serve as the study control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. |
| Mild renal impairment | EXPERIMENTAL | Participants have mild renal impairment (creatinine clearance (CLcr) = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. |
| Moderate renal impairment | EXPERIMENTAL | Participants have moderate renal impairment (creatinine clearance (CLcr) = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. |
| Severe renal impairment | EXPERIMENTAL | Participants have severe renal impairment (creatinine clearance (CLcr) \< 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection. |
| Name | Type | Description |
|---|---|---|
| Plerixafor | DRUG | - |
| Granulocyte-colony stimulating factor (G-CSF) | DRUG | 10 mcg/kg, solution, subcutaneous injection |
| Plerixafor (AMD3100) | DRUG | 0.24mg/kg SC for 2 to 7 days. |
| Can be any registered nonpegylated form of G-CSF | DRUG | 10mcg/kg SC for 4 days followed by an additional 2 to 7 days. |
| Placebo | DRUG | Single subcutaneous (SC) dose of placebo |
Inclusion Criteria: Donor: * Donor eligibility will be determined according to applicable federal, state and local regulations and institutional standards * 18-65 years of age * 6/6 HLA-matched sibling * Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor * Serum...
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Plerixafor is an investigational small molecule being studied for several oncology and transplant-related conditions, including metastatic pancreatic adenocarcinoma, Ewing's sarcoma/soft tissue sarcoma, acute myeloid leukemia, and failure of bone marrow graft. It is also studied in related donors donating peripheral blood stem cells to a family member and in healthy volunteers.
Plerixafor is being developed by Sanofi, a company traded under the ticker SNY. The drug is currently in Phase 1 clinical development for its studied indications.
Plerixafor is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains in early-stage development.
Plerixafor has been studied in several completed clinical trials, including NCT00445302, NCT01288573, NCT01696461, and NCT02179970. These trials investigated the drug in renal impairment, pediatric cancer patients, stem cell mobilization in related donors, and advanced pancreatic, ovarian, and colorectal cancers.
Plerixafor is a small molecule that targets the CXCR4 receptor, a chemokine receptor involved in cell migration and retention of stem cells in the bone marrow. By blocking this receptor, it mobilizes stem cells into the bloodstream, which is relevant for stem cell collection and potential anti-cancer effects.
Plerixafor is also known as AMD3100, as indicated in the clinical trial title for NCT00445302. This alternative name is used in research contexts, and both names refer to the same investigational drug.