A Randomized, Open-Label, Multicenter, Phase 2/3 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed C
- Conditions
- Relapsed Chronic Lymphocytic Leukemia (CLL)MedDRA version: 8.1Level: LLTClassification code 10008956Term: Chronic lymphatic leukaemia
- Registration Number
- EUCTR2006-002987-24-GB
- Lead Sponsor
- Biogen Idec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
? Signed, written Ethics Committee (EC)-approved informed consent form.
? Diagnosed relapsed CD23+ and CD20+ B-cell CLL as defined by National Cancer Institute-Working Group (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).
? World Health Organization (WHO) Performance Status < or = 2.
? Age > or = 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 < or = 2.0 mg/dL (34.2 µmol/L).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ? Acceptable hematologic status:
- Platelet count >or = 50 x 10exp9/L should be unsupported by transfusion.
- Absolute neutrophil count (ANC) > or = 1 x 109/L.
? Acceptable renal function:
- Creatinine clearance calculated according to the formula of Cockroft and Gault >50 mL/min.
- Serum creatinine < or =1.5 times upper limit of normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? Subjects who are refractory to the following combination therapies: purine analogue+rituximab, purine analogue+cyclophosphamide, or purine analogue+cyclophosphamide and rituximab. 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, pentastatin, and cladribine.
? Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day.
? Previous exposure to lumiliximab or other anti-CD23 antibodies.
? Prior autologous or allogeneic bone marrow transplant (BMT) or hematopoetic stem cell transplant.
? Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects 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 prolymphocyte leukemia [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 ? 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 electrocardiogram (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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method