NCT02933333
Unknown
Phase 4
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
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine7 sites in 1 country405 target enrollmentSeptember 27, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 405
- Locations
- 7
- Primary Endpoint
- assess the incidence of infection in patients after chemotherapy
- Last Updated
- 7 years ago
Overview
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.
Investigators
Xiaojun Yuan
chief physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 ≤
- •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.
Outcomes
Primary Outcomes
assess the incidence of infection in patients after chemotherapy
Time Frame: within 20 days after chemotherapy
Study Sites (7)
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