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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103558
Recruitment Status : Completed
First Posted : February 11, 2005
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Lumiliximab with FCR Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia
Study Start Date : March 2004
Primary Completion Date : January 2010
Study Completion Date : March 2010

Intervention Details:
    Drug: Lumiliximab with FCR
    Dose, schedule, and duration specified in protocol

Primary Outcome Measures :
  1. Characterize the safety profile [ Time Frame: monthly until month 12, then every 3 months for 24 months, then every 6 months until month 48 ]

Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics of lumiliximab and rituximab [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103558

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Diego, California, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Texas
Research Site
Houston, Texas, United States
Sponsors and Collaborators
Study Director: Medical Director Biogen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biogen Identifier: NCT00103558     History of Changes
Other Study ID Numbers: 152-30
First Posted: February 11, 2005    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: May 2010

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs