Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). FDA label
Also known as Plerixafor (AMD3100), Mozobil, AMD3000, AMD3100, Mozobil(TM)
plerixafor · 12 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
blood and bone marrow testing will be done to determine response to treatment every month
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 |
|---|---|---|
| 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. |
| 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 |
| Plerixafor + Chemo and G-CSF | OTHER | Patients who receive a combination of Plerixafor, chemotherapy and 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. |
| Cohort 1A | ACTIVE_COMPARATOR | Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 |
| Cohort 1B | ACTIVE_COMPARATOR | Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 |
| Cohort 2A | ACTIVE_COMPARATOR | Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 |
| Cohort 2B | ACTIVE_COMPARATOR | Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 2 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 4 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 |
| Cohort 3A | ACTIVE_COMPARATOR | Cycle 1: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 3: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 |
| Cohort 3B | ACTIVE_COMPARATOR | Cycle 1: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 2: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 4: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 |
| plerixafor | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| 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 |
| 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. |
| decitabine | DRUG | decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles |
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...
Plerixafor is used to mobilize stem cells from the bone marrow into the bloodstream for collection and autologous transplantation. It is studied in blood cancers including multiple myeloma, lymphoma, acute myeloid leukemia, and chronic lymphocytic leukemia, as well as in solid tumors such as Ewing's sarcoma and soft tissue sarcoma.
Plerixafor targets CXCR4, a chemokine receptor. It acts as a partial agonist at this receptor, which disrupts the interaction between CXCR4 and its ligand, leading to the release of hematopoietic stem cells from the bone marrow into peripheral blood.
Plerixafor is developed by Sanofi, which trades under the ticker SNY. The company is responsible for its clinical development and regulatory submissions.
Plerixafor is in Phase 1 clinical development for certain indications, according to the available data. It is an investigational agent and has not been approved by the FDA for the indications listed here.
Plerixafor has been evaluated in several completed trials, including NCT02179970 in advanced pancreatic, ovarian, and colorectal cancers; NCT01767714 in non-Hodgkin's lymphoma; NCT01753453 in multiple myeloma; and NCT01696461 in related donors and various blood cancers.
Yes, plerixafor is also known as AMD3100. Both names refer to the same small molecule drug developed by Sanofi.