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Lumiliximab with FCR

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |Biogen Inc.|Last Updated: Oct 2, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Lumiliximab with FCR · 1 trial · 1 indication

Phase 1 1
NCT00103558Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia
COMPLETED31 Analytics
PHASE1COMPLETED
Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic LeukemiaUnlock trial analytics

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 to 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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Frequently asked questions about Lumiliximab with FCR

What is Lumiliximab with FCR used for?

Lumiliximab with FCR is used for the treatment of chronic lymphocytic leukemia (CLL). It is specifically being studied in patients with relapsed CLL. The combination therapy is intended to address this blood cancer, which affects lymphocytes and can recur after initial treatment.

Who makes Lumiliximab with FCR?

Lumiliximab with FCR is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is responsible for the clinical development of this combination therapy for chronic lymphocytic leukemia.

What phase is Lumiliximab with FCR in?

Lumiliximab with FCR is in Phase 1 clinical development. It is an investigational combination therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with relapsed chronic lymphocytic leukemia.

What clinical trials is Lumiliximab with FCR in?

Lumiliximab with FCR has one completed clinical trial, identified as NCT00103558. This Phase 1 study, titled 'Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL),' enrolled 31 participants in the United States. The trial was uncontrolled and not randomized, and it included adults aged 18 years and older.

Is Lumiliximab with FCR FDA approved?

Lumiliximab with FCR is not FDA approved. It is an investigational combination therapy currently in Phase 1 clinical development for chronic lymphocytic leukemia. The drug has not completed the clinical trial process necessary to establish safety and efficacy for regulatory approval.