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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

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


Inclusion Criteria:



- 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 ┬Ámol/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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response (CR) rate

Outcome Time Frame:

Every 3 months until all patients have reached at least week 33

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

152CL201

NCT ID:

NCT00391066

Start Date:

November 2006

Completion Date:

December 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CD23+/CD20+ B-cell CLL
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Hays, Kansas  
Research Site Baton Rouge, Louisiana  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Belleville, New Jersey  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Abington, Virginia  
Research Site Auburn, Washington