CTRI/2009/091/000073已完成3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- To compare the duration of grade IV neutropenia between the two arms.
研究概览
简要总结
This study is a randomized, open labeled, parallel group phase III study to compare the efficacy, safety and cost effectiveness of low-dose non-glycosylated G-CSF (2.5 µg/kg/day) in 172 chemotherapy-induced neutropenia patients visiting Tata Memorial Centre, Mumbai, India. The primary objective being the comparison of efficacy, safety of low-dose versus standard-dose non-glycosylated G-CSF prophylaxis. The secondary objective is to compare the cost-effectiveness of low-dose with standard-dose non-glycosylated G-CSF in CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
入选标准
- •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 limits.
- •AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal.
- •creatinine.
- •creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 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.
排除标准
- •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.
结局指标
主要结局
To compare the duration of grade IV neutropenia between the two arms.
时间窗: 2 years (At the end of study)
次要结局
- The secondary efficacy endpoints would include comparative incidence of grade IV neutropenia, depth of Neutrophil nadir (mean + sd), total number of antibiotic and hospital days, total number of days of G-CSF total dose of G-CSF and relative safety as measured by reports of adverse events and changes in laboratory values between two arms.(2 years (At the end of study))
研究者
研究点 (1)
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