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Generic = Plerixafor

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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).PHASE3 COMPLETED 118 — — Sep 1, 2008Nov 1, 2010Mar 24, 201526 France, Germany +5
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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 — 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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