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

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ClinicalTrials.gov Identifier: NCT02314273
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
Xiamen Amoytop Biotech Co., Ltd.
Information provided by (Responsible Party):
Shanghai Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Pancytopenia Due to Chemotherapy Drug: rhIL-11 Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
Study Start Date : September 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


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 Name: Recombinant Human Interleukin-11

No Intervention: control group
control group



Primary Outcome Measures :
  1. platelet infusion [ Time Frame: 14 days ]
    frequency of platelet infusion


Secondary Outcome Measures :
  1. hemorrhagic tendency [ Time Frame: 14 days ]
    conditions of bleeding

  2. infection [ Time Frame: 14 days ]
    incident of infection during 14d after chemotherapy

  3. remission rate [ Time Frame: 14 days ]
    remission rate during 14d after chemotherapy

  4. platelet Count [ Time Frame: 14 days ]
    recovery of peripheral platelet count



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314273


Locations
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China, Beijing
Beijing Children's Hospital
Beijing, Beijing, China
China, Jiangsu
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Soochow University Affiliated Children's Hospital
Soochow, Jiangsu, China
China, Shanghai
Shanghai Children's Medical Center
Shanghai, Shanghai, China, 200127
Children's Hospital of Fudan University
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Children's Medical Center
Xiamen Amoytop Biotech Co., Ltd.
Investigators
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Study Chair: Tang Jingyan, M.D. Shanghai Children's Medical Center

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Responsible Party: Shanghai Children's Medical Center
ClinicalTrials.gov Identifier: NCT02314273     History of Changes
Other Study ID Numbers: TBK-10-01
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Thrombocytopenia
Pancytopenia
Blood Platelet Disorders
Hematologic Diseases
Oprelvekin
Antineoplastic Agents