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Houston, Texas

  • Chronic Lymphocytic Leukemia


This is an open label, Phase I/II, dose escalation research study of an investigational product called lumiliximab, given with FDA (Food and Drug Administration) approved products fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42 months or until your disease progresses and you require additional CLL therapy. The total duration of participation in the study will be approximately 4 years, however your disease status will be followed indefinitely (forever).


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 lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms - Prestudy WHO Performance Status less than or equal to 2 - Signed, written Institutional Review Board (IRB)-approved informed consent - Men & women of reproductive potential must agree to follow accepted birth control methods during treatment for 3 months after completion of treatment - Acceptable liver function: Bilirubin less than or equal to 2.0 mg/dL (26 µmol/L), AST (SGOT) &/or ALT (SGPT) less than or equal to 2 times upper limit of normal - Acceptable hematologic status: Platelet count less than or equal to 50 x 10^9/L, ANC less than or equal to 1 x 109/L - Acceptable renal function: Serum creatinine less than or equal to 1.5 times upper limit of normal Exclusion Criteria: - Subjects who did not respond to prior FCR therapy (relapsed within 6 months of the last dose). - Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1 - Previous exposure to lumiliximab or other anti-CD23 antibodies - Subjects who have had a prior allogenic bone marrow transplant (BMT) or autologous BMT or peripheral stem-cell transplant (PBSCT) - Known infection with HIV, hepatitis B, or hepatitis C - Uncontrolled diabetes mellitus - Uncontrolled hypertension - Transformation to aggressive B-cell malignancy (e.g., larger B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia (PLL) - Subjects with secondary malignancy requiring active treatment (except hormonal therapy) - Subjects with medical conditions currently requiring long-term use (less than 1 month) of systemic corticosteroids - Serious nonmalignant disease or laboratory abnormality, which, in the opinion of the investigator &/or sponsor, would compromise protocol objectives - Active uncontrolled bacteria, viral, or fungal infections - New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Study Day 1 - Seizure disorders requiring anticonvulsant therapy - Severe chronic obstructive pulmonary disease with hypoxemia - Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1 - Clinically active autoimmune disease - Subjects with a history of fludarabine-induced autoimmune cytopenia - Pregnant or currently breast-feeding

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

Official Title:

A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia

Overall Status:


Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Biogen Idec

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:March 2004
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:May 2010
Last Changed Date:May 6, 2010
First Received Date:February 10, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Evaluate the pharmacokinetics of lumiliximab and rituximab
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Characterize the safety profile
Time Frame:monthly until month 12, then every 3 months for 24 months, then every 6 months until month 48
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lumiliximab with FCR
Description:Dose, schedule, and duration specified in protocol

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Biogen Idec

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. Epub 2007 Nov 21.
Reference Type:Reference
Citation:Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55.

Data Source:

Date Processed: March 30, 2020

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