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 AMD3100, Mozobil
G-CSF Plus Plerixafor · 7 trials · 6 indications
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Proportion of participants who reached the target of at least 2\*10\^6 CD34+ cells/kg collected during up to 7 aphereses.
Proportion of participants who reached the target of at least 5\*10\^6 CD34+ cells/kg collected during up to 7 apheresis.
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
| Arm | Type | Description |
|---|---|---|
| G-CSF plus plerixafor | EXPERIMENTAL | Participants with CD20- lymphoma |
| G-CSF plus plerixafor and rituximab | EXPERIMENTAL | Participants with CD20+ lymphoma |
| Non-Hodgkin's Lymphoma (NHL) | EXPERIMENTAL | Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. |
| Multiple Myeloma (MM) | EXPERIMENTAL | Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. |
| Participants with Hodgkin's Disease (HD) | EXPERIMENTAL | Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation. |
| Plerixafor PM | EXPERIMENTAL | Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications. |
| Plerixafor AM | EXPERIMENTAL | Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications. |
| Low CD34+ Count/ Plerixafor PM | EXPERIMENTAL | Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of \>=10 cells/µL but \<20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications. |
| Plerixafor After Chemo | EXPERIMENTAL | This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached \>= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications. |
| Name | Type | Description |
|---|---|---|
| G-CSF plus plerixafor | DRUG | Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. |
| rituximab | BIOLOGICAL | Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF. |
| G-CSF and plerixafor | DRUG | G-CSF and plerixafor were administered as described in the treatment arms. |
Inclusion Criteria (abbreviated list): * Histological diagnosis of diffuse large cell lymphoma, B-cell, T-cell or anaplastic histologies; peripheral T-cell lymphoma; small non-cleaved Burkitt-like lymphoma; or Hodgkin disease. NOTE: Participants diagnosed at a facility outside of Emory University w...
G-CSF Plus Plerixafor is a stem cell mobilization regimen studied in autologous stem cell transplantation and in blood cancers including multiple myeloma, non-Hodgkin lymphoma, and Hodgkin's disease. It is given to increase the number of peripheral blood stem cells collected before transplant. All four listed trials are Phase 2 and completed.
Sanofi, which trades under the ticker SNY, is the developer associated with G-CSF Plus Plerixafor. The regimen combines plerixafor, a small molecule, with granulocyte-colony stimulating factor, or G-CSF. Plerixafor is also referred to by its research name AMD3100 in the trial titles for this program.
G-CSF Plus Plerixafor is in Phase 2 development. Four Phase 2 trials are listed, all of them completed, with no active trials currently recorded. The studies enrolled a total of 154 participants. The program covers autologous stem cell transplantation and several hematologic malignancies.
Four completed Phase 2 trials are listed for G-CSF Plus Plerixafor. NCT00396331 studied poor mobilizing adults who previously failed stem cell collection, enrolling 100 patients. NCT00444912 studied relapsed or refractory non-Hodgkin lymphoma or Hodgkin disease. NCT00396266 covered multiple myeloma and non-Hodgkin lymphoma, and NCT00396201 studied Hodgkin's disease.
Plerixafor, the small molecule component of G-CSF Plus Plerixafor, is studied as a mobilizing agent given alongside G-CSF to raise peripheral blood stem cell counts before collection. The regimen was evaluated in patients with multiple myeloma, non-Hodgkin lymphoma, Hodgkin's disease, and in poor mobilizers undergoing autologous stem cell transplantation.