G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
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
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.
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.
assess the incidence of infection in patients after chemotherapy
Acute Myeloid Leukemia
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
September 27, 2016
Primary Completion Date
August 30, 2020
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.
1 Year - 18 Years
Accepts Healthy Volunteers
Yuan Xiaojun, Ph.D, +86 13817266192, [email protected]
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yuan Xiaojun, Ph.D, Study Chair, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine