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Lumiliximab with FCR

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Biogen Inc.|Last Updated: Oct 2, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00103558Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)PHASE1 COMPLETED 31Mar 1, 2004Mar 1, 2010Oct 2, 20155 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile
monthly until month 12, then every 3 months for 24 months, then every 6 months until month 48
Secondary Endpoints
Evaluate the pharmacokinetics of lumiliximab and rituximab
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Lumiliximab with FCRDRUGDose, schedule, and duration specified in protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Age: 18 years and older * Diagnosis of B-cell CLL by International Workshop on CLL (IWCLL) response criteria * Relapsed CD23+ B-cell CLL * Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling or peripheral lymphocyt...

Countries:United States
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