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Generic = Plerixafor

Phase 3

Lymphoma (Non-Hodgkin's Lymphoma) | Small molecule | Oncology |Sanofi|Last Updated: Mar 24, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

Generic = Plerixafor · 1 trial · 4 indications

Phase 3 1
NCT00838357A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).Lymphoma (Non-Hodgkin's Lymphoma)
COMPLETED118 Analytics
PHASE3COMPLETED
A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).
Lymphoma (Non-Hodgkin's Lymphoma)
NCT00838357118
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Study Endpoints

Primary Endpoints

To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant
24 months

Secondary Endpoints

To assess efficacy of plerixafor and granulocyte-colony stimulating factor (G-CSF) as a mobilisation regimen as measured by the number of CD34+ cells collected in each apheresis session
After each dose of plerixafor
To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status
After transplantation
To examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status
After transplantation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlerixaforEXPERIMENTALPlerixafor added to a G-CSF Mobilisation regimen

Interventions

NameTypeDescription
Generic = PlerixaforDRUG240µg/kg administered as an SC injection 10 to 11 hours prior to initiation of apheresis. Daily administration for 1 up to 5 consecutive days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR) * Eligible and planned for an autologous haematopoietic stem cell transplantation * Written informed consent * At least 18 years of age (inclusive) * Eastern Cooperative Oncology Group (ECOG) perfor...

Countries:FranceGermanyItalyNetherlandsSpainSwedenUnited Kingdom
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Frequently asked questions about Generic = Plerixafor

What is Plerixafor used for?

Plerixafor is a small molecule being studied for use in lymphoma, specifically non-Hodgkin's lymphoma, as well as Hodgkin's disease and multiple myeloma. It is being investigated as a front-line mobilization agent in combination with G-CSF to prepare patients for transplantation.

Who makes Plerixafor?

Plerixafor is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY.

What phase is Plerixafor in?

Plerixafor is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the indications being studied.

What clinical trials is Plerixafor in?

Plerixafor has one completed Phase 3 clinical trial, identified as NCT00838357. This was a multi-centre, open-label, single-arm study that enrolled 118 patients with lymphoma, Hodgkin's disease, or multiple myeloma, and was conducted across several European countries.

Is Plerixafor the same as Mozobil?

Plerixafor is the generic name for the drug also known by the brand name Mozobil. The clinical trial NCT00838357 refers to the drug as plerixafor, and it is the same compound marketed under the Mozobil brand.