A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination with Lumiliximab Versus FCR Alone in Subjects with Previously Untreated Chronic Lymphocytic Leukemia.

• Conditions: Previously Untreated Chronic Lymphocytic Leukemia (CLL); MedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemia

• Registration Number: EUCTR2008-002204-25-GB
• Lead Sponsor: Biogen Idec Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Age =18 years at the time of informed consent.
3. Previously untreated CD23+ and CD20+ B cell CLL as defined by NCI-WG Guidelines (1996).
4. Life expectancy >6 months in the opinion of the Investigator.
5. Subjects with Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have active disease as evidenced by massive or progressive splenomegaly, massive or progressive lymphadenopathy rapid doubling of peripheral lymphocyte count, or B symptoms (see Appendix B, Staging Criteria – Modified Rai).
6. World Health Organization (WHO) Performance Status=2.
7. Normal ECG with QTc =450 msec for men and =460 msec for women. PR interval (PRint) must be <240 msec and QRS complex <110 msec. T wave flattening and T wave inversion will be permitted.
8. All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 12 months after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
9. Acceptable liver function at Screening:
• Bilirubin=2.0 mg/dL (34.2 µmol/L).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=2 times the upper limit of normal.
10. Acceptable hematologic status at Screening:
• Platelet count =50 x 109/L not supported by transfusion.
• Absolute neutrophil count (ANC) =1 x 109/L.
11. Acceptable renal function at Screening:
• Creatinine clearance calculated according to the formula of Cockroft and Gault > 50 mL/min.
• Serum creatinine =1.5 times the upper limit of normal.
12. Subjects receiving any medication known to affect the QTc interval must discontinue the use of medication or be on a stable dose of medication for at least 3 months or 5 half lives (whichever is longer) prior to Study Day 1, and continue (whenever possible) at the same dose throughout the study.

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

1. Any prior therapy for CLL, including radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, allogeneic/autologous bone marrow transplant, peripheral blood stem cell transplant, or other investigational therapy.
2. Known history of or positive test result for human immunodeficiency virus.
3. Known history of, or positive test result for Hepatitis C virus (test for Hepatitis C virus antibody) or Heptatitis B virus (test for Hepatitis B Surface Antigen and Hepatitis B Core Antibody) at Screening.
4. Uncontrolled diabetes mellitus.
5. Uncontrolled hypertension.
6. Hypokalemia, as defined by potassium below the lower limit of normal in the central laboratory results at Screening.
7. Hypomagnesemia, as defined by magnesium below th lower limit of normal in the central laboratory results at Screening.
8. New York Heart Association Class III or IV cardiac disease; myocardial infarction within the past 6 months prior to Study Day 1.
9. Arrhythmia (other than sinus arrhythmia) within 30 days prior to Study Day 1.
10. Evidence of active myocardial ischemia on ECG (new T wave changes with chest pain or presence of elevation of cardiac enzymes) within 30 days prior to
Study Day 1.
11. Subjects with pacemakers.
12. Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter’s Syndrome, or prolymphocyte leukemia [PLL]).
13. Secondary malignancy requiring active treatment.
14. Any medical condition that would require long-term use ( > 1 month) of systemic corticosteroids during study treatment, and use of systemic corticosteroids for treatment of CLL during the study for any time period.
15. Any serious nonmalignant disease or laboratory abnormality, which would confound the evaluation of AEs.
16. Active bacterial, viral, or fungal infections.
17. Any known family history of long QT syndrome.
18. Seizure disorders requiring anticonvulsant therapy.
19. Severe chronic obstructive pulmonary disease with hypoxemia.
20. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
21. Clinically active autoimmune disease.
22. Presence or history of Coombs-positive hemolytic anemia.
23. Pregnant or currently breastfeeding at Screening.
24. Prior exposure to lumiliximab or other anti-CD23 antibody.
25. Subjects with known hypersensitivity to Chinese hamster ovary cell proteins, murine proteins, or any component of fludarabine, cyclophosphamide, rituximab, or the lumiliximab investidational treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified