rhIL-11
Drugpatients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL
Other names: Recombinant Human Interleukin-11
Completed
NCT Number: NCT02314273
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
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.
Completed
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Notify MeKey information
Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Beijing Children's Hospital, Beijing, Beijing Municipality, China
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About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- new diagnosis of ALL
- TBIL≤34umol/L，Cr≤120umol/L，a normal EF
- age <18 years
Exclusion criteria
- patients with uncontrolled infection
- patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
Treatment and study plan
Primary outcomes
-
platelet infusion
Time frame: 14 days
frequency of platelet infusion
Secondary outcomes
-
hemorrhagic tendency
Time frame: 14 days
conditions of bleeding
-
infection
Time frame: 14 days
incident of infection during 14d after chemotherapy
-
remission rate
Time frame: 14 days
remission rate during 14d after chemotherapy
-
platelet Count
Time frame: 14 days
recovery of peripheral platelet count
Sponsors and collaborators
Lead sponsor
Shanghai Children's Medical Center
Other
Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
Registry information
Official study title
Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 11, 2014
- Registry last updated
- Dec 11, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.