A Randomized, Open-Label, Multicenter, Phase 2 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 - ND

Conditions: Chronic Lymphocytic Leukemia
MedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia

Registration Number: EUCTR2006-002987-24-IT

Lead Sponsor: BIOGEN IDEC LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 276

Inclusion Criteria

 Signed, written Ethics Committee (EC)-approved informed consent form.  Relapsed CD23+ and CD20+ B-cell CLL as defined by National Cancer Institute-Working Group (NCI-WG) Guidelines.  Subjects who have received no more than 2 prior single agent or combination treatments for progressive disease.  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 2.  Age 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 2.0 mg/dL (26 ?mol/L).  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2 times upper limit of normal.  Acceptable hematologic status:  Platelet count 50  109/L should be unsupported by transfusion.  Absolute neutrophil count (ANC) 1  109/L.  Acceptable renal function:  Creatinine clearance calculated according to the formula of Cockroft and Gault >50 mL/min.  Serum creatinine 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

Exclusion Criteria

 Subjects who are refractory to fludarabine and rituximab (FR), fludarabine and cyclophosphamide (FC), or FCR. Refractory is defined as not achieving at least a partial response for a minimum duration of 6 months as determined by treating physician.  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 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 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
Main Objective: To determine the effectiveness of lumiliximab when used in combination with FCR compared with FCR alone for the treatment of subjects with relapsed CLL.;Secondary Objective: To evaluate and compare the safety profile of subjects treated with lumiliximab in combination with FCR versus FCR alone in subjects with relapsed CLL.;Primary end point(s): complete response (CR) rate

Secondary Outcome Measures