Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL

Pancytopenia Due to Chemotherapy Clinical Trial

Official title:

Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314273
• Other study ID #: TBK-10-01
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2014
• Last updated: December 8, 2014
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2014
• Source: Shanghai Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancytopenia
• Pancytopenia Due to Chemotherapy
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• rhIL-11
patients receive rhIL-11(50 mcg/kg,subcutaneously)after standard chemotherapy,once a day for 10 days or until platelet count =80000/mL

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing
China	Nanjing Children's Hospital	Nanjing	Jiangsu
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Children's Medical Center	Shanghai	Shanghai
China	Soochow University Affiliated Children's Hospital	Soochow	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center	Xiamen Amoytop Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet infusion	frequency of platelet infusion	14 days	Yes
Secondary	hemorrhagic tendency	conditions of bleeding	14 days	Yes
Secondary	infection	incident of infection during 14d after chemotherapy	14 days	Yes
Secondary	remission rate	remission rate during 14d after chemotherapy	14 days	Yes
Secondary	platelet Count	recovery of peripheral platelet count	14 days	Yes