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Last Updated: January 24, 2020

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CLINICAL TRIALS PROFILE FOR PLERIXAFOR

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505(b)(2) Clinical Trials for Plerixafor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT00901225 Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant Completed Genzyme, a Sanofi Company Phase 2 2009-05-01 Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population. The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
New Indication NCT00901225 Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant Completed Duke University Phase 2 2009-05-01 Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population. The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Plerixafor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00082329 G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2004-05-01 This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
NCT00082329 G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers Completed Richard Childs, M.D. Phase 2 2004-05-01 This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
NCT00103610 Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients Completed Genzyme, a Sanofi Company Phase 3 2005-01-01 The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.
NCT00103662 Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients Completed Genzyme, a Sanofi Company Phase 3 2005-01-01 The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
NCT00241358 Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies Completed Washington University School of Medicine Phase 1/Phase 2 2004-05-01 The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
NCT00322387 Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Completed Genzyme, a Sanofi Company Phase 2 2004-04-01 Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Plerixafor

Condition Name

Condition Name for Plerixafor
Intervention Trials
Multiple Myeloma 28
Non-Hodgkin's Lymphoma 10
Lymphoma, Non-Hodgkin 9
Acute Myeloid Leukemia 9
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Condition MeSH

Condition MeSH for Plerixafor
Intervention Trials
Multiple Myeloma 36
Lymphoma, Non-Hodgkin 34
Neoplasms, Plasma Cell 30
Leukemia 28
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Clinical Trial Locations for Plerixafor

Trials by Country

Trials by Country for Plerixafor
Location Trials
United States 199
Canada 11
France 7
United Kingdom 6
Italy 6
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Trials by US State

Trials by US State for Plerixafor
Location Trials
California 21
Missouri 20
New York 14
Texas 11
Maryland 11
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Clinical Trial Progress for Plerixafor

Clinical Trial Phase

Clinical Trial Phase for Plerixafor
Clinical Trial Phase Trials
Phase 4 5
Phase 3 9
Phase 2 47
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Clinical Trial Status

Clinical Trial Status for Plerixafor
Clinical Trial Phase Trials
Completed 50
Recruiting 29
Active, not recruiting 16
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Clinical Trial Sponsors for Plerixafor

Sponsor Name

Sponsor Name for Plerixafor
Sponsor Trials
Genzyme, a Sanofi Company 44
National Cancer Institute (NCI) 14
Washington University School of Medicine 12
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Sponsor Type

Sponsor Type for Plerixafor
Sponsor Trials
Other 144
Industry 69
NIH 22
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