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

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00103558

First received: February 10, 2005

Last updated: May 6, 2010

Last verified: May 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 10, 2005
Last Updated Date	May 6, 2010
Start Date ^ICMJE	March 2004
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 3, 2008)	Characterize the safety profile [ Time Frame: monthly until month 12, then every 3 months for 24 months, then every 6 months until month 48 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Characterize the safety profile and determine a recommended Phase II dose (RP2D) of lumiliximab given in combination with fludarabine, cyclophosphamide, and rituximab
Change History	Complete list of historical versions of study NCT00103558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 3, 2008)	Evaluate the pharmacokinetics of lumiliximab and rituximab [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Evaluate the pharmacokinetics (PK) of lumiliximab and rituximab Evaluate the potential efficacy of lumiliximab given in combination with fludarabine, cyclophosphamide, and rituximab Evaluate the immunogenicity of lumiliximab by monitoring for human antilumiliximab antibody formation.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
Official Title ^ICMJE	A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Lymphocytic Leukemia
Intervention ^ICMJE	Drug: Lumiliximab with FCR Dose, schedule, and duration specified in protocol
Study Arm (s)	Not Provided
Publications *	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. 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. Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2009 Oct 20; [Epub ahead of print]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	31
Completion Date	March 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00103558
Other Study ID Numbers ^ICMJE	152-30
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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