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| Name | Class |
|---|---|
| Shanghai Jiao Tong University Affiliated First People's Hospital | UNKNOWN |
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We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to < 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhGM-CSF group | Experimental | subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily |
|
| rhG-CSF+rhGM-CSF group | Active Comparator | a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each |
|
| rhG-CSF group | Active Comparator | subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhGM-CSF group | Drug | subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Invasive Fungal Diseases (IFD) | The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation | 100 day post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Hematological Engraftment | The median time of neutrophil and platelet recovery . | 100 days post transplant |
| Transplant Related Mortality | Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Wang, M.D. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China | ||
| Henan Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26392095 | Derived | Wan L, Zhang Y, Lai Y, Jiang M, Song Y, Zhou J, Zhang Z, Duan X, Fu Y, Liao L, Wang C. Effect of Granulocyte-Macrophage Colony-Stimulating Factor on Prevention and Treatment of Invasive Fungal Disease in Recipients of Allogeneic Stem-Cell Transplantation: A Prospective Multicenter Randomized Phase IV Trial. J Clin Oncol. 2015 Dec 1;33(34):3999-4006. doi: 10.1200/JCO.2014.60.5121. Epub 2015 Sep 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | rhGM-CSF Group | subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| FG001 | rhG-CSF+ rhGM-CSF Group | a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| FG002 | rhG-CSF Group | subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rhGM-CSF Group | subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| BG001 | rhG-CSF+ rhGM-CSF Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Hematological Engraftment | The median time of neutrophil and platelet recovery . | The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients . | Posted | Median | Full Range | days | 100 days post transplant |
|
28 days post transplant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rhGM-CSF Group | subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
The limitations of the current study included the lack of blinding and placebo group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chun Wang | Department of Hematology, Shanghai Jiao Tong University Affiliated First People's Hospital, China | wangchun2@medmail.com.cn |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| rhG-CSF+rhGM-CSF group | Drug | a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
|
|
| rhG-CSF group | Drug | subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
|
|
| 100 days post transplant |
| Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD) | Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading). | 100 days post transplant |
| IFD Related Mortality | IFD-related mortalities after a median follow-up of 600 days. | 3-1099 days |
| Relapse Related Mortality | Relapse related mortality after a median follow-up of 600 days. | 3～1099 days |
| Graft Versus Host Disease (aGVHD) Related Mortality | Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days . | 3-1099 days |
| Hemorrhage Related Mortality | Hemorrhage related mortality after a median follow-up of 600 days | 3-1099 days |
| Infection Related Mortality | Infection related mortality after a median follow-up of 600 days. | 3～1099 days) |
| Zhengzhou |
| Henan |
| 450003 |
| China |
| Wuhan Tongji Hospital | Wuhan | Hubei | 430030 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| BG002 | rhG-CSF Group | subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | rhG-CSF Group | subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). |
|
|
| Secondary | Transplant Related Mortality | Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT). | The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients . | Posted | Number | 95% Confidence Interval | percentage of participants | 100 days post transplant |
|
|
|
| Secondary | Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD) | Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading). | The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients . | Posted | Number | 95% Confidence Interval | percentage of partipants | 100 days post transplant |
|
|
|
| Primary | Incidences of Invasive Fungal Diseases (IFD) | The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation | The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients . | Posted | Number | percentage of partipants | 100 day post transplant |
|
|
|
| Secondary | IFD Related Mortality | IFD-related mortalities after a median follow-up of 600 days. | The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients . | Posted | Number | 95% Confidence Interval | percentage of participants | 3-1099 days |
|
|
|
| Secondary | Relapse Related Mortality | Relapse related mortality after a median follow-up of 600 days. | The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients . | Posted | Number | percentage of participants | 3～1099 days |
|
|
|
| Secondary | Graft Versus Host Disease (aGVHD) Related Mortality | Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days . | The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients . | Posted | Number | percentage of participants | 3-1099 days |
|
|
|
| Secondary | Hemorrhage Related Mortality | Hemorrhage related mortality after a median follow-up of 600 days | The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients . | Posted | Number | percentage of participants | 3-1099 days |
|
|
|
| Secondary | Infection Related Mortality | Infection related mortality after a median follow-up of 600 days. | The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients . | Posted | Number | percentage of participants | 3～1099 days) |
|
|
|
| 0 |
| 68 |
| 32 |
| 68 |
| EG001 | rhG-CSF + rhGM-CSF Group | a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). | 0 | 69 | 31 | 69 |
| EG002 | rhG-CSF Group | subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). | 0 | 69 | 28 | 69 |
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| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |