None listed
Conditions
Interventions
Drug : In 24 hours after R-FC or FC chemotherapy (i.e.chemotherapy starting 4th day), fix-dose once 6mg of Pegfilgrastim(Neulasta®) is subcutaneously injected with independent the results of serum ANC
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Woo Jeon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed