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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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
Sponsor: Shanghai Children's Medical Center

Current Primary Outcome: platelet infusion [ Time Frame: 14 days ]

frequency of platelet infusion


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • hemorrhagic tendency [ Time Frame: 14 days ]
    conditions of bleeding
  • infection [ Time Frame: 14 days ]
    incident of infection during 14d after chemotherapy
  • remission rate [ Time Frame: 14 days ]
    remission rate during 14d after chemotherapy
  • platelet Count [ Time Frame: 14 days ]
    recovery of peripheral platelet count


Original Secondary Outcome: Same as current

Information By: Shanghai Children's Medical Center

Dates:
Date Received: July 25, 2014
Date Started: September 2011
Date Completion:
Last Updated: December 8, 2014
Last Verified: November 2014