Granulocyte Colony-Stimulating FactorEarly Phase 1NCT05970185
The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization
A Early Phase 1 study testing PEG-rhG-CSF and G-CSF in people with Granulocyte Colony-Stimulating Factor, run by Zhongnan Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulocyte Colony-Stimulating Factor
- What is being tested?
- PEG-rhG-CSF and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Apr 2024
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant lymphoma diagnosed by histology and/or cytology; expected survival > 3 months.
- Patients evaluated for disease in complete or partial remission.
- Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
- Liver function and biochemical tests need to meet the following criteria. ALT and AST ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.
- PS score of 0-2.
- Age ≥ 18.
- Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception for the duration of the trial.
- Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.
Who cannot join
- Pregnant or lactating women.
- having other hematological disorders affecting the hematopoietic function of the bone marrow
- those with acute or active infections who have received systemic anti-infective therapy within 72h
- who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
- Those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
- Other conditions that, in the judgment of the investigator, are not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital
The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.
Read the detailed description
Treatment programs The mobilization protocol is.
- etoposide 0.1 grams per square meter qd d1-3
- algocytidine 0.5 grams per square meter q12h d1-3
- whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection).
In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was >0.1% and peripheral blood leukocytes were >3.5×109/L.
Collection was stopped when the CD34+ cell count was >5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.
- Conditions
- Granulocyte Colony-Stimulating Factor
- Being tested
- PEG-rhG-CSF, G-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
G-CSFDrug
G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy Receives: Drug: PEG-rhG-CSF |
| G-CSF | Active comparator | G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection Receives: Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total CD34+ cell yield (106/kg)
Total CD34+ cell yield (106/kg)
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Accuracy differences between immunomagnetic bead assays and flow cytometry assays
Differences in the accuracy of immunomagnetic bead assay and flow cytometry in the detection of CD34+ cells after mobilization in lymphoma patients prepped for stem cell transplantation
Measured: through study completion, an average of 1 year
Height
height in meters
Measured: One day before chemotherapy
Weight
Weight in kg
Measured: One day before chemotherapy
Vital signs and physical examination
Exclude unrelated organic disease by imaging studies
Measured: One day before chemotherapy
ECOG score (d1 pre-chemotherapy)
The ECOG scoring standard (Eastern Cooperative Oncology Group) is an index to understand the patient's general health status and tolerance to treatment from the patient's physical strength. The patient's activity status is divided into 6 grades from 0 to 5, with higher scores indicating worse outcomes.
Measured: One day before chemotherapy
Blood routine
Blood routine: Blood routine was tested daily, and peripheral blood CD34+ cell percentage was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if CD34+ percentage was >0.1% and peripheral blood leukocytes were >3.5×109/L.
Measured: Blood routine was tested daily, an average of 1 year
Adverse event record
Adverse event record: record any adverse events that occurred during the drug administration.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuling Zhou, Zhongnan Hospital
- Investigators
- Fuling Zhou, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970185
- Sponsor's protocol ID
- 07
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital
- ClinicalTrials.gov ID
- NCT05970185
- Acronym / sponsor ID
- 07
- Conditions
- Granulocyte Colony-Stimulating Factor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.
Detailed description
Treatment programs The mobilization protocol is.
- etoposide 0.1 grams per square meter qd d1-3
- algocytidine 0.5 grams per square meter q12h d1-3
- whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection).
In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was >0.1% and peripheral blood leukocytes were >3.5×109/L.
Collection was stopped when the CD34+ cell count was >5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSFSubcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy |
| G-CSF | Active comparator | Drug: G-CSFG-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Malignant lymphoma diagnosed by histology and/or cytology; expected survival > 3 months.
- Patients evaluated for disease in complete or partial remission.
- Normal bone marrow hematopoietic function; no significant cardiac or pulmonary dysfunction.
- Liver function and biochemical tests need to meet the following criteria. ALT and AST ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.
- PS score of 0-2.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- having other hematological disorders affecting the hematopoietic function of the bone marrow
- those with acute or active infections who have received systemic anti-infective therapy within 72h
- who are allergic to the study drug or other G-CSF products, or to biological agents expressed by E. coli
- Those who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study
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-CSFSubcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy | Drug | PEG-rhG-CSF |
| G-CSFG-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection | Drug | G-CSF |
Primary outcome
Total CD34+ cell yield (106/kg)
Time frame: through study completion, an average of 1 year
Total CD34+ cell yield (106/kg)
7 secondary outcomes
Accuracy differences between immunomagnetic bead assays and flow cytometry assays
Time frame: through study completion, an average of 1 year
Height
Time frame: One day before chemotherapy
Weight
Time frame: One day before chemotherapy
Vital signs and physical examination
Time frame: One day before chemotherapy
ECOG score (d1 pre-chemotherapy)
Time frame: One day before chemotherapy
Blood routine
Time frame: Blood routine was tested daily, an average of 1 year
Adverse event record
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
Fuling Zhou study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PEG-rhG-CSF and G-CSF in people with Granulocyte Colony-Stimulating Factor, run by Zhongnan Hospital at 1 site 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 8 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Fuling Zhou (+862767813137, zhoufuling@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total CD34+ cell yield (106/kg) (time frame: through study completion, an average of 1 year). 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 18 Jan 2024.