Granulocyte Colony-stimulating FactorPhase 4NCT05409547
A Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for PEG-G-CSF
A Phase 4 study testing PEG-rhG-CSF in people with Granulocyte Colony-stimulating Factor and Stem Cell Mobilization, run by Ning Huang.
Trial summary
Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization (PBSCM) and autologous… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Granulocyte Colony-stimulating Factor, Stem Cell Mobilization
- What is being tested?
- PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Apr 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;
- Patients who receive APBSCT voluntarily;
- Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;
- Each subject must sign the informed consent from (ICF) to indicate that he/she understands the purposes and procedures of the study, and participates in the study voluntarily. Considering the patient's conditions, if the patient's signature is not conducive to treatment, his/her legal representative will sign the ICF.
Who cannot join
- Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;
- Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;
- Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;
- Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, with drug dependence, with uncontrolled mental illness, or with cognitive dysfunction;
- Subjects who participate in other similar clinical studies within 3 months;
- Subjects who are considered as unsuitable for the study by the investigator (e.g., those expected to be unable to adhere to relevant treatment regimen due to financial problems).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Open, Randomized, Controlled Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for Pegylated Recombinant Human Granulocyte Colony Stimulating Factor
Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization (PBSCM) and autologous peripheral blood stem cell transplantation (APBSCT).
Primary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in PBSCM.
Secondary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in APBSCT.
Read the detailed description
Key issues to be addressed:
To compare the efficiency of stem cell mobilization and hematopoietic system reconstruction between PEG-rhG-CSF and rrhG-CSF.
Research design:
A multicenter, open, prospective randomized controlled clinical study.
Research objects:
Patients with hematological diseases who will receive autologous hematopoietic stem cell mobilization (including lymphoma, myeloma patients who achieved PRand MRD-negative acute leukemia patients ).
Number of cases:
There will be 40 cases in the treatment group and the control group, respectively. The cases will be randomly divided into PEG-rhG-CSF or rhG-CSF control group to receive treatment. The cases will be assigned to 1 experimental group and 1 control group in a 1:1 ratio.
Experiment design Overall design A multicenter, randomized, open-controlled study will be used. We will include patients who meet the indications of autologous hematopoietic stem cell transplantation as the research objects. Chemotherapy will be given prior to mobilization: chemotherapy regimens will be given to patients before mobilization according to the type of disease (such as etoposide alone, cyclophosphamide alone, VP-16+ CTX, medium-dose cytarabine, etc.). The experimental group will receive subcutaneous injection of PEG-rhG-CSF (6 mg) once on the 2nd day after chemotherapy. For the control group, the peripheral blood changes will be closely monitored after chemotherapy, and rhG-CSF (5 μg/kg/d) will be applied twice a day at the beginning of the leukocyte rising phase until the acquisition ends. The patients who meet the requirements for enrollment will be randomly divided into the experimental group and the control group in a 1:1 ratio.
Total number of cases This phase of the clinical trial will include patients who meet the indications for autologous hematopoietic stem cell transplantation as the research subjects, and the included patients will be randomly divided into different-dose PEG-rhG-CSF group or rhG-CSF control group to receive treatment. This trial plans to enroll 80 patients and assign them to 1 experimental group and 1 control group in a 1:1 ratio.
Dose for mobilization
Experimental group:
PEG-rhG-CSF 6 mg/d (single dose) will be given on the second day after chemotherapy. Routine peripheral blood test and CD34+ cell count will be done 1 day before collection.
Control group:
rhG-CSF (5 μg/kg/d) will be given twice a day, and peripheral blood stem cells will be collected on the 5th day. Routine peripheral blood test and CD34+ cell count will be done 1 day before collection. rhG-CSF (5 μg/kg/d) twice a day could be temporarily added if CD34+ cell count is less than 20/μL.
Collection of stem cells:
Stem cells will be collected by a blood cell separator. If the number of CD34+ collected on the first day is not enough, the collection will continue on the second day, with a collection time ≤5 hours. Judgment of collection results: ①Successful collection: the number of CD34+ cells obtained in one collection is ≥2×10^6/kg; ②Failure of collection: the number of CD34+ cells obtained by 3 collections is less than 2×10^6/kg; ③ Excellent collection: the number of CD34+ cells obtained in one collection is ≥5×10^6/kg.
Preconditioning scheme All transplant patients will receive preconditioning therapy according to their disease type.
Stem cell reinfusion Hematopoietic stem cells will be reinfused for all cases 24 hours after the end of preconditioning therapy. The total amount of hematopoietic stem cells reinfused in each group: MNC≥4.0×10^8/kg, and CD34+ cells≥2.0×10^6/kg. The actual volume of reinfusion of each group will be recorded.
Hematopoietic reconstitution criteria After reinfusion of hematopoietic stem cells, if blood cells continue to decline and then rise again, and neutrophils exceed 0.5×10^9/L for 3 consecutive days, the leukocyte reconstitution criteria are met; In the absence of platelet transfusion, if platelet count is greater than 20×10^9/L for 3 consecutive times, the platelet reconstitution criteria are met.
Experimental drug:
PEG-rhG-CSF vs. rhG-CSF.
Promotion of bone marrow reconstruction:
Starting on the 4th day after hematopoietic stem cell reinfusion, rhG-CSF will be administered at a dose of 5μg/kg/d until the granulocytes rise to more than 5000/ul and become stable.
- Being tested
- PEG-rhG-CSF
- Keywords
- Hematopoietic stem cell mobilization, Hematopoietic stem cell transplantation, pegylated granulocyte colony-stimulating factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Also called rhG-CSF
PEG-rhG-CSF 6 mg/d (single dose) will be given on the second day after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| PEG-G-CSF | Experimental | 6 mg, single dose Receives: Drug: PEG-rhG-CSF |
| rhG-CSF | Active comparator | 5 μg/kg, twice a day Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of stem cell mobilization
Count of collected CD34+ cells (CD34+ > 2×10^6 /kg will be considered as successful mobilization).
Measured: 3years
Secondary outcomes (1)
Time of hematopoietic reconstitution
- The time period(days) between reinfusion of hematopoietic stem cells and neutrophils exceed 0.5×10^9/L for 3 consecutive days.
- The time period(days) between reinfusion of hematopoietic stem cells and platelet count is greater than 20×10^9/L for 3 consecutive times.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulocyte Colony-stimulating FactorStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Huang, Qianfoshan Hospital
- Investigators
- ning huang, Professor, Principal investigator, professorkehong bi, Professor, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409547
- Sponsor's protocol ID
- YKLL-KY-2022(009)
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Randomized, Controlled Clinical Study of Autologous Peripheral Blood Stem Cell Mobilization for Pegylated Recombinant Human Granulocyte Colony Stimulating Factor
- ClinicalTrials.gov ID
- NCT05409547
- Acronym / sponsor ID
- YKLL-KY-2022(009)
- Keywords
- Hematopoietic stem cell mobilization, Hematopoietic stem cell transplantation, pegylated granulocyte colony-stimulating factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ning HuangUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 Jun 2022 (actual)
- 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.
Have a comparison between pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and recombinant human granulocyte-colony stimulating factor (rhG-CSF) for difference in efficacy of hematopoietic reconstruction after autologous peripheral blood stem cell mobilization (PBSCM) and autologous peripheral blood stem cell transplantation (APBSCT).
Primary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in PBSCM.
Secondary purpose:
Compare the difference between PEG-rhG-CSF and G-CSF in APBSCT.
Detailed description
Key issues to be addressed:
To compare the efficiency of stem cell mobilization and hematopoietic system reconstruction between PEG-rhG-CSF and rrhG-CSF.
Research design:
A multicenter, open, prospective randomized controlled clinical study.
Research objects:
Patients with hematological diseases who will receive autologous hematopoietic stem cell mobilization (including lymphoma, myeloma patients who achieved PRand MRD-negative acute leukemia patients ).
Number of cases:
There will be 40 cases in the treatment group and the control group, respectively. The cases will be randomly divided into PEG-rhG-CSF or rhG-CSF control group to receive treatment. The cases will be assigned to 1 experimental group and 1 control group in a 1:1 ratio.
Experiment design Overall design A multicenter, randomized, open-controlled study will be used. We will include patients who meet the indications of autologous hematopoietic stem cell transplantation as the research objects. Chemotherapy will be given prior to mobilization: chemotherapy regimens will be given to patients before mobilization according to the type of disease (such as etoposide alone, cyclophosphamide alone, VP-16+ CTX, medium-dose cytarabine, etc.). The experimental group will receive subcutaneous injection of PEG-rhG-CSF (6 mg) once on the 2nd day after chemotherapy. For the control group, the peripheral blood changes will be closely monitored after chemotherapy, and rhG-CSF (5 μg/kg/d) will be applied twice a day at the beginning of the leukocyte rising phase until the acquisition ends. The patients who meet the requirements for enrollment will be randomly divided into the experimental group and the control group in a 1:1 ratio.
Total number of cases This phase of the clinical trial will include patients who meet the indications for autologous hematopoietic stem cell transplantation as the research subjects, and the included patients will be randomly divided into different-dose PEG-rhG-CSF group or rhG-CSF control group to receive treatment. This trial plans to enroll 80 patients and assign them to 1 experimental group and 1 control group in a 1:1 ratio.
Dose for mobilization
Experimental group:
PEG-rhG-CSF 6 mg/d (single dose) will be given on the second day after chemotherapy. Routine peripheral blood test and CD34+ cell count will be done 1 day before collection.
Control group:
rhG-CSF (5 μg/kg/d) will be given twice a day, and peripheral blood stem cells will be collected on the 5th day. Routine peripheral blood test and CD34+ cell count will be done 1 day before collection. rhG-CSF (5 μg/kg/d) twice a day could be temporarily added if CD34+ cell count is less than 20/μL.
Collection of stem cells:
Stem cells will be collected by a blood cell separator. If the number of CD34+ collected on the first day is not enough, the collection will continue on the second day, with a collection time ≤5 hours. Judgment of collection results: ①Successful collection: the number of CD34+ cells obtained in one collection is ≥2×10^6/kg; ②Failure of collection: the number of CD34+ cells obtained by 3 collections is less than 2×10^6/kg; ③ Excellent collection: the number of CD34+ cells obtained in one collection is ≥5×10^6/kg.
Preconditioning scheme All transplant patients will receive preconditioning therapy according to their disease type.
Stem cell reinfusion Hematopoietic stem cells will be reinfused for all cases 24 hours after the end of preconditioning therapy. The total amount of hematopoietic stem cells reinfused in each group: MNC≥4.0×10^8/kg, and CD34+ cells≥2.0×10^6/kg. The actual volume of reinfusion of each group will be recorded.
Hematopoietic reconstitution criteria After reinfusion of hematopoietic stem cells, if blood cells continue to decline and then rise again, and neutrophils exceed 0.5×10^9/L for 3 consecutive days, the leukocyte reconstitution criteria are met; In the absence of platelet transfusion, if platelet count is greater than 20×10^9/L for 3 consecutive times, the platelet reconstitution criteria are met.
Experimental drug:
PEG-rhG-CSF vs. rhG-CSF.
Promotion of bone marrow reconstruction:
Starting on the 4th day after hematopoietic stem cell reinfusion, rhG-CSF will be administered at a dose of 5μg/kg/d until the granulocytes rise to more than 5000/ul and become stable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-G-CSF | Experimental | Drug: PEG-rhG-CSF6 mg, single dose |
| rhG-CSF | Active comparator | Drug: PEG-rhG-CSF5 μg/kg, twice a day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed as hematological diseases definitely, body weight ≥30kg, age: 18-60 years, without limitation in gender or race;
- Patients who receive APBSCT voluntarily;
- Patients who participate in the open randomized controlled study of autologous hematopoietic stem cell mobilization for PEG-rhG-CSF and G-CSF voluntarily;
- Each subject must sign the informed consent from (ICF) to indicate that he/she understands the purposes and procedures of the study, and participates in the study voluntarily. Considering the patient's conditions, if the patient's signature is not conducive to treatment, his/her legal representative will sign the ICF.
Key exclusion criteria (6 listed)
- Patients who have serious organ dysfunctions or diseases, such as serious diseases or dysfunctions heart, liver, kidney, pancreas and etc.;
- Patients who cannot tolerate autologous hematopoietic stem cell transplantation and autologous stem cell mobilization;
- Subjects who and/or whose authorized family members refuse HSCT or PEG-rhG-CSF treatment;
- Subjects with any life-threatening disease, medical condition or organ system dysfunction compromising their safety or causing unnecessary risks for the study results in the investigator' opinion, with drug dependence, with uncontrolled mental illness, or with cognitive dysfunction;
- Subjects who participate in other similar clinical studies within 3 months;
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 |
|---|---|---|
| PEG-rhG-CSFAlso: rhG-CSFPEG-rhG-CSF 6 mg/d (single dose) will be given on the second day after chemotherapy. | Drug | PEG-G-CSF, rhG-CSF |
Primary outcome
Efficiency of stem cell mobilization
Time frame: 3years
Count of collected CD34+ cells (CD34+ > 2×10^6 /kg will be considered as successful mobilization).
1 secondary outcome
Time of hematopoietic reconstitution
Time frame: 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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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.
ning huang, Professor principal investigator
professor
kehong bi, Professor study director
professor
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-rhG-CSF in people with Granulocyte Colony-stimulating Factor and Stem Cell Mobilization, run by Ning Huang.
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 6 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 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 ning huang, Professor (13006594815, huangninghbsct@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of stem cell mobilization (time frame: 3years). 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 16 Jun 2022.