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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR MOZOBIL


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All Clinical Trials for Mozobil

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.
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.
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).
NCT00322491 ↗ Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients Completed AnorMED Phase 2 2004-03-01 This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mozobil

Condition Name

Condition Name for Mozobil
Intervention Trials
Multiple Myeloma 17
Lymphoma 5
Acute Myeloid Leukemia 5
Lymphoma, Non-Hodgkin 5
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Condition MeSH

Condition MeSH for Mozobil
Intervention Trials
Multiple Myeloma 21
Neoplasms, Plasma Cell 20
Lymphoma, Non-Hodgkin 19
Lymphoma 19
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Clinical Trial Locations for Mozobil

Trials by Country

Trials by Country for Mozobil
Location Trials
United States 150
Canada 10
Italy 3
Germany 3
United Kingdom 2
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Trials by US State

Trials by US State for Mozobil
Location Trials
California 17
Missouri 12
New York 11
Washington 11
Massachusetts 8
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Clinical Trial Progress for Mozobil

Clinical Trial Phase

Clinical Trial Phase for Mozobil
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Mozobil
Clinical Trial Phase Trials
Completed 53
Terminated 13
Recruiting 8
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Clinical Trial Sponsors for Mozobil

Sponsor Name

Sponsor Name for Mozobil
Sponsor Trials
Genzyme, a Sanofi Company 30
National Cancer Institute (NCI) 13
Fred Hutchinson Cancer Research Center 6
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Sponsor Type

Sponsor Type for Mozobil
Sponsor Trials
Other 92
Industry 45
NIH 25
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