Acute Myeloid LeukemiaPhase 4NCT02933333
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
A Phase 4 study testing GM-CSF, G-CSF and GM-CSF and G-CSF in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma
- What is being tested?
- GM-CSF, G-CSF and GM-CSF and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 7 sitesChina
- Study dates
- 27 Sep 2016to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Shandong Province Qianfoshan Hospital
Jinan, Shandong, 250000
Wang Hongming, Ph.D
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Sun Lirong, Ph.D
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Zhai Xiaowen, Ph.D
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality, 200000
Yuan Xiaojun, Ph.D, +86 13817266192, xhxjyuan@hotmail.com
Zou Fenfang, scholar, +86 18959232025, zoufenfang@amoytop.com
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 210000
Hu Shaoyan, Ph.D
- Recruiting
Northwest Women's Hospital
Xi'an, Shangxi, 710000
Pan Kaili, Master
- Recruiting
The First Affiliated of Xiamen University
Xiamen, Fujian, 350000
Wen Hong, Ph.D
About this study
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
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.
Read the detailed description
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Neuroblastoma, Hepatoblastoma, Retinoblastoma
- Being tested
- GM-CSF, G-CSF, GM-CSF and G-CSF
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Neuroblastoma, Hepatoblastoma, Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFBiological
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils.
G-CSFBiological
Granulocyte colony-stimulating factor (G-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. G-CSF is a relatively specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage.
GM-CSF and G-CSFBiological
Granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF and G-CSF share a number of biologic activities, GM-CSF seems to be more potent against fungi.
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | 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. Receives: Biological: GM-CSF |
| G-CSF | Experimental | Eligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. Receives: Biological: G-CSF |
| G-CSF + GM-CSF | Experimental | Eligible patients received subcutaneous a combination of GM-CSF 5 μg/kg per day and G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF and G-CSF are given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. Receives: Biological: GM-CSF and G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the incidence of infection in patients after chemotherapy
Measured: within 20 days after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start27 Sep 2016
- Primary completion30 Aug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Yuan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yuan Xiaojun, Ph.D, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineZhai Xiaowen, Ph.D, Principal investigator, Children's Hospital of Fudan UniversityHu Shaoyan, Ph.D, Principal investigator, Children's Hospital of Soochow UniversityFang Yongjun, Ph.D, Principal investigator, Nanjing Children's HospitalWen Hong, Ph.D, Principal investigator, The First Affiliated of Xiamen UniversityWang Hongmei, Ph.D, Principal investigator, Qianfoshan HospitalSun Lirong, Ph.D, Principal investigator, The Affiliated Hospital of Qingdao UniversityLi Aimin, Ph.D, Principal investigator, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933333
- Sponsor's protocol ID
- XH-16-021
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02933333
- Acronym / sponsor ID
- XH-16-021
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Lymphoma, Neuroblastoma, Hepatoblastoma, Retinoblastoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Biological: GM-CSFEligible 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. |
| G-CSF | Experimental | Biological: G-CSFEligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. |
| G-CSF + GM-CSF | Experimental | Biological: GM-CSF and G-CSFEligible patients received subcutaneous a combination of GM-CSF 5 μg/kg per day and G-CSF 5 μg/kg per day when the first time of absolute neutrophil count [ANC] <1.5*10^9/L after chemotherapy. GM-CSF and G-CSF are given daily for at least 5 days and continued until the ANC reached 1.5*10^9/L for two consecutive days. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CSFGranulocyte-macrophage colony-stimulating factor (GM-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. | Biological | GM-CSF |
| G-CSFGranulocyte colony-stimulating factor (G-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. G-CSF is a relatively specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage. | Biological | G-CSF |
| GM-CSF and G-CSFGranulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF and G-CSF share a number of biologic activities, GM-CSF seems to be more potent against fungi. | Biological | G-CSF + GM-CSF |
Primary outcome
assess the incidence of infection in patients after chemotherapy
Time frame: within 20 days after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Xiaojun, Ph.D study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhai Xiaowen, Ph.D principal investigator
Children's Hospital of Fudan University
Hu Shaoyan, Ph.D principal investigator
Children's Hospital of Soochow University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GM-CSF, G-CSF and GM-CSF and G-CSF in people with Acute Myeloid Leukemia and Acute Lymphoid Leukemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan NO Xiaojun, Ph.D (+86 13817266192, xhxjyuan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the incidence of infection in patients after chemotherapy (time frame: within 20 days after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.