Pancytopenia Due to Chemotherapy
Conditions
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
Interventions
DRUGrhIL-11
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL
Sponsors
Xiamen Amoytop Biotech Co., Ltd.
Shanghai Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet infusion | 14 days | frequency of platelet infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemorrhagic tendency | 14 days | conditions of bleeding |
| infection | 14 days | incident of infection during 14d after chemotherapy |
| remission rate | 14 days | remission rate during 14d after chemotherapy |
| platelet Count | 14 days | recovery of peripheral platelet count |
Countries
China
Outcome results
None listed