Status:
TERMINATED
Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Biogen
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab i...
Eligibility Criteria
Inclusion
- Signed, written EC-approved informed consent form.
- Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by NCI WG guidelines.
- Subjects who have received at least 1 but no more than 2 prior single agent or combination treatments for CLL.
- Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Criteria - Modified Rai).
- WHO Performance Status less than or equal to 2.
- Age greater than or equal to 18 years.
- Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
- Acceptable liver function: bilirubin less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal.
- Acceptable hematologic status: platelet count greater than or equal to 50 x 10\^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10\^9/L.
- Acceptable renal function: creatinine clearance calculated according to the formula of Cockcroft and Gault \>50 mL/min; serum creatinine less than or equal to 1.5 times upper limit of normal.
Exclusion
- Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues include fludarabine, pentostatin and cladribine.
- 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.
- Prior autologous or allogeneic BMT or hematopoetic stem cell transplant.
- Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.
- Uncontrolled diabetes mellitus.
- Uncontrolled hypertension.
- Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter's Syndrome, or PLL).
- Secondary malignancy requiring active treatment (except hormonal therapy).
- Any medical condition that would require long-term use (\>1 month) of systemic corticosteroids during study treatment. However, steroid use less than or equal to 1 month is permissible during the study.
- Any serious nonmalignant disease or laboratory abnormality, which in the opinion of the Investigator and/or Sponsor would compromise protocol objectives.
- Active uncontrolled bacterial, 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 30 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.
- History of fludarabine-induced autoimmune cytopenia (as judged by the Investigator) or Coombs-positive haemolytic anemia.
- Pregnant or currently breastfeeding.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT00391066
Start Date
November 1 2006
End Date
December 1 2010
Last Update
October 2 2015
Active Locations (194)
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1
Research Site
Scottsdale, Arizona, United States
2
Research Site
Alhambra, California, United States
3
Research Site
Burbank, California, United States
4
Research Site
Fullerton, California, United States