open–labeled, multicenter phase II study of the evaluation of single administration Pegfilgrastim once per cycle as an adjunct to R-FC (rituximab plus fludarabine and cyclophosphamide) or FC combination chemotherapy in patients with newly diagnosed or relapsed chronic lymphocytic leukemia
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
1)=18 years of age, adult
2)Have active disase status per the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
3)Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1,2
4)Newly diagnosed CLL or relapsed CLL patients who have no fludarabine-based chemotherapy
5)Planning for R-FC or FC combination chemotherapy
6)Adequate liver function test and favorable renal func2tion
- Serum creatinine < 1.5 fold of high normal limit
- Serum bilirubin < 1.5 fold of high normal limit
- ALT and alkaline phosphatase < 3 fold of high normal limit
1)Prior treatment with fludaraine-based combination chemotherapy.
2)Concurrent enrollement in another therapeutic investigational study.
3)Received a hematopoietic stem cell transplantation.
4)History of prior malignancy.
5)Known history of Human Immunodeficiency Virus(HIV) or hepatitis C, or active infection with Hepatitis B or Hepatitis C.
6)pregnancy, breast feeding.
7)Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfuction which, in the invstigator’s opinion, could compreomise the subject’s safety, interfere with the absorption or metabolism of Pegfilgrastim(Neulasta®), or put the study outcomes at undue risk.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to determine the incidence and duration of grade 3/4 neutropenia (definition : absolute neutrophil count ,ANC <1.0 x 109/L) in each chemotherapy cycles.
- Secondary Outcome Measures
Name Time Method to investigate of neutropenia-assoicated hospitalization, neutropenia -related chemotherapy dose delays or reduction, and incidence;to evaulation o fPegfilgrastim (Neulasta®) -related complications (fever. rash, abnormal blood test) and safety