MycosesPhase 4NCT01232504
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
A Phase 4 study testing rhGM-CSF group, rhG-CSF+rhGM-CSF group and rhG-CSF group in people with Mycoses, run by Xiamen Amoytop Biotech Co., Ltd. at 5 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycoses
- What is being tested?
- rhGM-CSF group, rhG-CSF+rhGM-CSF group and rhG-CSF group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 5 sitesChina
- Study dates
- Sep 2009to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14~60 years old
- Allogenic hematological stem cell transplantation(HSCT) patients.
- Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal.
- Informed consent.
Who cannot join
- Evidence of proven, probable or possible fungal infection at the time of enrollment.
- Patients were receiving anti-fungal treatment with proven SFI before transplantation.
- A history of hypersensitivity to G-CSF or GM-CSF.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Wuhan Tongji Hospital
Wuhan, Hubei, 430030
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial
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.
Read the detailed description
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.
- Conditions
- Mycoses
- Being tested
- rhGM-CSF group, rhG-CSF+rhGM-CSF group, rhG-CSF group
- Keywords
- Allo-HSCT, rhGM-CSF, Systemic fungal infection (SFI)
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGM-CSF groupDrug
Also called Topleucon®, Granulocyte Macrophage Colony Stimulating Factor
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).
rhG-CSF+rhGM-CSF groupDrug
Also called Topleucon®, Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Colony Stimulating Factor
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 groupDrug
Also called Granulocyte Colony Stimulating Factor, Topleucon®
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).
| Study group | Role | What they receive |
|---|---|---|
| rhGM-CSF group | Experimental | subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily Receives: Drug: rhGM-CSF group |
| 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 Receives: Drug: rhG-CSF+rhGM-CSF group |
| rhG-CSF group | Active comparator | subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily Receives: Drug: rhG-CSF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Invasive Fungal Diseases (IFD)
The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
Measured: 100 day post transplant
Secondary outcomes (8)
Hematological Engraftment
The median time of neutrophil and platelet recovery .
Measured: 100 days post transplant
Transplant Related Mortality
Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).
Measured: 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).
Measured: 100 days post transplant
IFD Related Mortality
IFD-related mortalities after a median follow-up of 600 days.
Measured: 3-1099 days
Relapse Related Mortality
Relapse related mortality after a median follow-up of 600 days.
Measured: 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 .
Measured: 3-1099 days
Hemorrhage Related Mortality
Hemorrhage related mortality after a median follow-up of 600 days
Measured: 3-1099 days
Infection Related Mortality
Infection related mortality after a median follow-up of 600 days.
Measured: 3～1099 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MycosesStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Chun Wang, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232504
- Sponsor's protocol ID
- L-09-01
- Status last verified
- Oct 2014
- First submitted
- 25 Oct 2010
- Last updated
- 4 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26392095
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial
- ClinicalTrials.gov ID
- NCT01232504
- Acronym / sponsor ID
- L-09-01
- Conditions
- Mycoses
- Keywords
- Allo-HSCT, rhGM-CSF, Systemic fungal infection (SFI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Jiao Tong University Affiliated First People's Hospital
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 27 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhGM-CSF group | Experimental | Drug: rhGM-CSF groupsubcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily |
| rhG-CSF+rhGM-CSF group | Active comparator | Drug: rhG-CSF+rhGM-CSF groupa 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 | Drug: rhG-CSF groupsubcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 14~60 years old
- Allogenic hematological stem cell transplantation(HSCT) patients.
- Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal.
- Informed consent.
Key exclusion criteria (3 listed)
- Evidence of proven, probable or possible fungal infection at the time of enrollment.
- Patients were receiving anti-fungal treatment with proven SFI before transplantation.
- A history of hypersensitivity to G-CSF or GM-CSF.
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 |
|---|---|---|
| rhGM-CSF groupAlso: Topleucon®, Granulocyte Macrophage Colony Stimulating Factorsubcutaneous 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). | Drug | rhGM-CSF group |
| rhG-CSF+rhGM-CSF groupAlso: Topleucon®, Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Colony Stimulating Factora 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). | Drug | rhG-CSF+rhGM-CSF group |
| rhG-CSF groupAlso: Granulocyte Colony Stimulating Factor, Topleucon®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). | Drug | rhG-CSF group |
Primary outcome
Incidences of Invasive Fungal Diseases (IFD)
Time frame: 100 day post transplant
The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
8 secondary outcomes
Hematological Engraftment
Time frame: 100 days post transplant
Transplant Related Mortality
Time frame: 100 days post transplant
Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)
Time frame: 100 days post transplant
IFD Related Mortality
Time frame: 3-1099 days
Relapse Related Mortality
Time frame: 3～1099 days
Graft Versus Host Disease (aGVHD) Related Mortality
Time frame: 3-1099 days
Hemorrhage Related Mortality
Time frame: 3-1099 days
Infection Related Mortality
Time frame: 3～1099 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26392095Wan 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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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.
Chun Wang, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
5 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 rhGM-CSF group, rhG-CSF+rhGM-CSF group and rhG-CSF group in people with Mycoses, run by Xiamen Amoytop Biotech Co., Ltd. at 5 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Invasive Fungal Diseases (IFD) (time frame: 100 day post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232504, which also lists 1 linked publication.
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 4 Nov 2014.