A randomized open labeled parallel group phase III study of low-dose versus standard-dose granulocyte colony stimulating factor prophylaxis in pediatric cancer patients receiving myelosuppressive chemotherapy.

Terry Fox Foundation0 个研究点目标入组 172 人开始时间: 待定最近更新: 2021年11月24日

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•Newly diagnosed pediatric (age < 18 yrs) patients with acute lymphoblastic leukemia in first complete remission after induction and planned for consolidation chemotherapy or patients with rhabdomyosarcoma (RMS)/Ewing?s sarcoma (ES) and osteogenic sarcoma (OGS) planned for first cycle of chemotherapy.
•ECOG performance status < 2 (Karnofsky >=60%).
•Life expectancy of greater than 6 months.
•Patients must have normal organ and marrow function as defined below
•- Leukocytes > 3,000/mcL
•- absolute Neutrophil count > 1,500/mcL
•- platelets > 100,000/mcL
•- total bilirubin - within normal institutional
•- AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper
•limit of normal.
•- creatinine - within normal institutional
•- creatinine clearance > 60 mL/min/1.73 m2 for
•patients with creatinine
•levels above institutional
•Bone marrow in remission (< 5% blasts in marrow) in ALL or not involved at baseline in RMS and OGS
•Ability of patients to understand and the willingness to sign a written informed consent.

•Patients who have had GCSF prior to entering the study or those who have not recovered from adverse events due to agents administered earlier.
•Patients may not be receiving /received any other investigational agents within past 4 weeks.
•Any planned radiotherapy during the study period.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
•Prior systemic anti-infective treatment within 72 hours of chemotherapy.

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