Status:
COMPLETED
Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Biogen
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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, cycloph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00103558
Start Date
March 1 2004
End Date
March 1 2010
Last Update
October 2 2015
Active Locations (5)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
San Diego, California, United States
3
Research Site
Baltimore, Maryland, United States
4
Research Site
Columbus, Ohio, United States