G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor

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Brief Title

G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor

Official Title

G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor: a Prospective, Multicentre, Randomised Controlled Trial

Brief Summary

      The purpose of this study is to explore the effect of G-CSF combination with GM-CSF on
      prevention and treatment of infection in children with malignant tumor.
    

Detailed Description

      G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children
      With Malignant Tumor.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

assess the incidence of infection in patients after chemotherapy


Condition

Acute Myeloid Leukemia

Intervention

GM-CSF

Study Arms / Comparison Groups

 GM-CSF
Description:  Eligible patients received subcutaneous GM-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

405

Start Date

September 27, 2016

Completion Date

December 2020

Primary Completion Date

August 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with malignant tumor including acute myeloid leukemia (AML) after complete
             remission, acute lymphocytic leukemia (ALL) after complete remission, stage III or IV
             lymphoma after partial remission or complete remission, stage III or IV neuroblastoma
             (NB) or retinoblastoma (RB).

          -  Eastern Cooperative Oncology Group performance status ≤ 2.

          -  Did not receive treatment of CSFs in two weeks.

          -  Without symptomatic infection and with normal values of C-reactive protein or
             procalcitonin.

          -  The first time of ANC < 1.5*10^9/L after chemotherapy.

          -  More than 24 h after the last chemotherapy.

          -  The function of liver was normal.

        Exclusion Criteria:

          -  Allergic to GM-CSF or drugs which expressed in Escherichia coli.

          -  Patients with infection, diabetes or primary immunodeficiency.

          -  Patients infected with hepatitis B, hepatitis C or HIV.

          -  Patients confirmed autoimmune thrombocytopenic purpura.
      

Gender

All

Ages

1 Year - 18 Years

Accepts Healthy Volunteers

No

Contacts

Yuan Xiaojun, Ph.D, +86 13817266192, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02933333

Organization ID

XH-16-021


Responsible Party

Principal Investigator

Study Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine


Study Sponsor

Yuan Xiaojun, Ph.D, Study Chair, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine


Verification Date

October 2018