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Last Updated: December 6, 2022

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
NCT00075335 ↗ AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2004-01-01 Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoetic stem cells for allogeneic transplantation because of technical ease of collection and shorter time required for engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF) has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% will mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow harvesting. Although G-CSF is generally well tolerated in healthy donors, it may be associated with bone pain, headache, myalgia and rarely life threatening side effects like stroke, myocardial infarction and splenic rupture. AMD3100, is a bicyclam compound that inhibits the binding of stromal cell derived factor-1 (SDF-1) to its cognate receptor CXC- chemokine receptor 4 (CXCR4). CXCR4 is present on cluster of differentiation 34 (CD34)+ hematopoetic progenitor cells and its interaction with stromal cell derived factor 1 (SDF-1) plays a pivotal role in the homing of CD34+ cells in the bone marrow. Inhibition of the CXCR4-SDF1 axis by AMD3100 releases CD34+ cells into the circulation, which can then be collected easily by apheresis. Recently, a published report demonstrated that large numbers of CD34+ cells were rapidly mobilized in healthy volunteers following a single subcutaneous injection of AMD3100. Remarkably, the number of CD34+ cells collected by apheresis following a single injection of AMD3100 was comparable to the number of CD34+ cells collected from historical controls receiving 5 days of G-CSF prior to stem cell mobilization. In this study we will collect PBPCs following a single subcutaneous injection of AMD3100 from healthy donors who have previously had PBPC collected using standard G-CSF mobilization. The AMD3100 mobilized cells, G-CSF mobilized cells, and circulating cells prior to both AMD3100 and G-CSF mobilization will be analyzed in terms of cellular content and function of lymphocytes, natural killer (NK) cells, and antigen presenting cells. AMD3100 mobilized PBPC will be collected for the purpose of research studies and will not be used for therapeutic purposes.
NCT00082329 ↗ G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2004-06-18 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 2004-06-18 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Plerixafor

Condition Name

Condition Name for Plerixafor
Intervention Trials
Multiple Myeloma 32
Non-Hodgkin's Lymphoma 10
Lymphoma, Non-Hodgkin 9
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Condition MeSH

Condition MeSH for Plerixafor
Intervention Trials
Multiple Myeloma 41
Neoplasms, Plasma Cell 34
Lymphoma, Non-Hodgkin 34
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Clinical Trial Locations for Plerixafor

Trials by Country

Trials by Country for Plerixafor
Location Trials
United States 224
Spain 17
Canada 11
France 7
United Kingdom 6
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Trials by US State

Trials by US State for Plerixafor
Location Trials
California 24
Missouri 20
New York 16
Maryland 15
Texas 13
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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/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Plerixafor
Clinical Trial Phase Trials
Completed 81
Terminated 23
Recruiting 22
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Clinical Trial Sponsors for Plerixafor

Sponsor Name

Sponsor Name for Plerixafor
Sponsor Trials
Genzyme, a Sanofi Company 45
National Cancer Institute (NCI) 16
Washington University School of Medicine 12
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Sponsor Type

Sponsor Type for Plerixafor
Sponsor Trials
Other 177
Industry 88
NIH 31
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