Back to resultsEffect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
Primary Purpose
Pancytopenia Due to Chemotherapy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rhIL-11
Sponsored by
About this trial
This is an interventional treatment trial for Pancytopenia Due to Chemotherapy
Eligibility Criteria
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
Sites / Locations
- Beijing Children's Hospital
- Nanjing Children's Hospital
- Soochow University Affiliated Children's Hospital
- Shanghai Children's Medical Center
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rhIL-11 group
control group
Arm Description
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL
control group
Outcomes
Primary Outcome Measures
platelet infusion
frequency of platelet infusion
Secondary Outcome Measures
hemorrhagic tendency
conditions of bleeding
infection
incident of infection during 14d after chemotherapy
remission rate
remission rate during 14d after chemotherapy
platelet Count
recovery of peripheral platelet count
Full Information
NCT ID
NCT02314273
First Posted
July 25, 2014
Last Updated
December 8, 2014
Sponsor
Shanghai Children's Medical Center
Collaborators
Xiamen Amoytop Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02314273
Brief Title
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
Official Title
Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Children's Medical Center
Collaborators
Xiamen Amoytop Biotech Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancytopenia Due to Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhIL-11 group
Arm Type
Experimental
Arm Description
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
rhIL-11
Other Intervention Name(s)
Recombinant Human Interleukin-11
Intervention Description
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL
Primary Outcome Measure Information:
Title
platelet infusion
Description
frequency of platelet infusion
Time Frame
14 days
Secondary Outcome Measure Information:
Title
hemorrhagic tendency
Description
conditions of bleeding
Time Frame
14 days
Title
infection
Description
incident of infection during 14d after chemotherapy
Time Frame
14 days
Title
remission rate
Description
remission rate during 14d after chemotherapy
Time Frame
14 days
Title
platelet Count
Description
recovery of peripheral platelet count
Time Frame
14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Jingyan, M.D.
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Children's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Soochow University Affiliated Children's Hospital
City
Soochow
State/Province
Jiangsu
Country
China
Facility Name
Shanghai Children's Medical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
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