Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
- Registration Number
- NCT02314273
- Lead Sponsor
- Shanghai Children's Medical Center
- Brief Summary
The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.
- Detailed Description
Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- new diagnosis of ALL
- TBIL≤34umol/L，Cr≤120umol/L，a normal EF
- age <18 years
- patients with uncontrolled infection
- patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhIL-11 group rhIL-11 patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL
- Primary Outcome Measures
Name Time Method platelet infusion 14 days frequency of platelet infusion
- Secondary Outcome Measures
Name Time Method platelet Count 14 days recovery of peripheral platelet count
remission rate 14 days remission rate during 14d after chemotherapy
hemorrhagic tendency 14 days conditions of bleeding
infection 14 days incident of infection during 14d after chemotherapy
Trial Locations
- Locations (5)
Nanjing Children's Hospital
🇨🇳Nanjing, Jiangsu, China
Beijing Children's Hospital
🇨🇳Beijing, Beijing, China
Shanghai Children's Medical Center
🇨🇳Shanghai, Shanghai, China
Soochow University Affiliated Children's Hospital
🇨🇳Soochow, Jiangsu, China
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China