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

December 8, 2014 updated by: Shanghai Children's Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Children's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Children's Hospital
      • Soochow, Jiangsu, China
        • Soochow University Affiliated Children's Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center
      • Shanghai, Shanghai, China
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhIL-11 group
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL
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
Other Names:
  • Recombinant Human Interleukin-11
No Intervention: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet infusion
Time Frame: 14 days
frequency of platelet infusion
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemorrhagic tendency
Time Frame: 14 days
conditions of bleeding
14 days
infection
Time Frame: 14 days
incident of infection during 14d after chemotherapy
14 days
remission rate
Time Frame: 14 days
remission rate during 14d after chemotherapy
14 days
platelet Count
Time Frame: 14 days
recovery of peripheral platelet count
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Children's Medical Center

Collaborators

Xiamen Amoytop Biotech Co., Ltd.

Investigators

  • Study Chair: Tang Jingyan, M.D., Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBK-10-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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