Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational combination being studied for stem cell mobilization in patients with multiple myeloma, non-Hodgkin lymphoma, and related conditions requiring autologous stem cell transplantation. It is developed by Sanofi and is currently in Phase 2 clinical development.
G-CSF Plus Plerixafor combines granulocyte colony-stimulating factor with plerixafor, a small molecule that blocks the CXCR4 receptor. This blockade helps release stem cells from the bone marrow into the bloodstream, enhancing their collection for autologous stem cell transplantation.
G-CSF Plus Plerixafor is developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. The combination is being investigated for its role in stem cell mobilization for patients with blood cancers.
G-CSF Plus Plerixafor is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. All completed trials for this combination are Phase 2 studies.
G-CSF Plus Plerixafor has completed four Phase 2 trials: NCT00322387, NCT00322491, NCT00322842, and NCT00396266. These studies enrolled a total of 124 participants with multiple myeloma or non-Hodgkin lymphoma across the United States, Germany, and Canada.
G-CSF Plus Plerixafor is a combination regimen that includes plerixafor, also known as AMD3100, along with G-CSF. While plerixafor is a single agent, the combination is studied specifically for its enhanced stem cell mobilization effects in transplant settings.