LymphomaNCT06060080
Efficacy and Safety of PEG-rhG-CSF Injection for Neutrophil Reconstitution Following AHSCT in Lymphoma/Multiple Myeloma
A study testing pegylated recombinant human granulocyte-colony stimulating factor in people with Lymphoma and Multiple Myeloma, run by Yao Liu at 1 site in China.
Trial summary
This study evaluates the effectiveness and safety of PEG-rhG-CSF injection for the reconstruction of neutrophil cells after autologous hematopoietic stem cell transplantation in lymphoma/multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma
- What is being tested?
- pegylated recombinant human granulocyte-colony stimulating factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 30 Apr 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, any gender;
- Patients with lymphoma/multiple myeloma requiring autologous hematopoietic stem cell transplantation;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 before transplantation;
- Basic normal function of heart, lungs, liver, and kidneys (no severe heart disease, no severe lung disease; transaminases ≤ 3× upper limit of normal, blood bilirubin ≤ 2.0 mg/dl; blood creatinine ≤ 2× upper limit of normal);
- Pre-transplant blood counts meet the following criteria: ANC (Absolute Neutrophil Count) ≥ 1.5×10^9/L, HGB (Hemoglobin) ≥ 90g/L, PLT (Platelets) ≥ 100×10^9/L;
- No other severe diseases that conflict with this protocol;
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- Expected survival of ≥ 3 months and willingness to follow-up;
- Voluntary participation in this clinical trial and signing of informed consent;
- The investigator believes that the subject will benefit from participation.
Who cannot join
- Patients with splenomegaly;
- Individuals who have previously undergone allogeneic or autologous hematopoietic stem cell transplantation;
- HIV antibody-positive, HbsAg-positive, or HCV antibody-positive;
- Impaired liver or kidney function (transaminases >3× ULN or blood bilirubin >2.0 mg/dl; blood creatinine >2× ULN);
- Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on electrocardiogram, or myocardial infarction within the last Six months;
- Clinical symptoms of cognitive impairment or severe mental illness;
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- Allergic reactions to polyethylene glycol recombinant human granulocyte colony-stimulating factor injection or recombinant human granulocyte colony-stimulating factor injection;
- Pregnant or breastfeeding women;
- Investigators believe participation in this clinical trial is unsuitable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yao Liu, 13228684685, 64823926@qq.com
About this study
Official title: Medical Professor,CHONGQING UNIVERSITY CANCER HOSPITAL
This study evaluates the effectiveness and safety of PEG-rhG-CSF injection for the reconstruction of neutrophil cells after autologous hematopoietic stem cell transplantation in lymphoma/multiple myeloma patients.
Read the detailed description
This study is a single-center, open-label clinical trial. Inclusion criteria involve patients with confirmed lymphoma or multiple myeloma receiving autologous hematopoietic stem cell transplantation for the first time. After calculating the sample size, an initial cohort of 40 trial patients is expected to be enrolled. Patients meeting the eligibility criteria will be assigned to receive PEG-rhG-CSF treatment on the second day after hematopoietic stem cell infusion, with a fixed dose of 6 mg. The primary outcome measure of this study is the median time for neutrophil cell reconstruction. Secondary study endpoints include safety indicators of the medication, the duration of neutrophil cell reduction (ANC≤2.0×10^9/L), the number of days patients spend in the laminar flow ward after transplantation, the usage of antibiotics, antifungal, or antiviral drugs, as well as patient expenditures, among other indicators.
Criteria for withdrawal/discontinuation of treatment:
(1) Subjects voluntarily request to withdraw from the trial;(2) Subjects who, although not explicitly requesting withdrawal from the trial, no longer adhere to the trial protocol for treatment and assessments, resulting in loss to follow-up; (3) Subjects with poor compliance who switch treatment regimens midway or use prohibited drugs within the protocol; (4) Subjects who were incorrectly enrolled; (5) Subjects experiencing intolerable allergic reactions or adverse events; (6) Subjects who pass away; (7) Other situations that meet the exclusion criteria arise.
Management of detachment cases:
When patients withdraw from the study due to allergic reactions or adverse events, researchers should take appropriate treatment measures based on the subject's condition. For mid-study withdrawal or loss to follow-up, researchers should actively take measures to complete the final assessment to analyze their efficacy and safety. All dropout cases should be documented in the case report form, and the trial conclusion form should be filled out along with the reasons for the subject dropout.
- Conditions
- Lymphoma, Multiple Myeloma
- Being tested
- pegylated recombinant human granulocyte-colony stimulating factor
- Keywords
- PEG-rhG-CSF, Autologous Hematopoietic Stem Cell, Transplantation, Effectiveness, Safety
- Medical subject headings
- Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated recombinant human granulocyte-colony stimulating factorDrug
Also called PEG-rhG-CSF
Lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Study on PEG-rhG-CSF in the Treatment of Lymphoma/Multiple Myeloma | Experimental | In this study, lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed. Receives: Drug: pegylated recombinant human granulocyte-colony stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to neutrophil cell reconstruction
day-based
Measured: 0-21 days
Secondary outcomes (4)
Blood Tests
Counts： red blood cells [male:(4.3-5.8)×10¹²/L ),female:(3.8-5.1)×10¹²/L]; white blood cells (3.5-9.5×10^9/L); neutrophils (1.5~8.0)×10^9/L; lymphocytes (0.8-3.5)X10^9/L; and platelets (100-300)×10^9/L.
Measured: 30 days
Duration of absolute neutrophil count (ANC)
The normal range for neutrophil count is approximately 1.8-6.3 x 10^9/L. If the ANC (Absolute Neutrophil Count) falls to ≤2.0 x 10^9/L, it is considered a possible side effect caused by the experimental drug used in this cancer patient.
Measured: 30 days
Number of days staying in the laminar flow ward after transplantation
A laminar flow ward is used to prevent the risk of infection in patients undergoing their first autologous hematopoietic stem cell transplantation treatment.Typically, after receiving autologous hematopoietic stem cell transplantation treatment, patients reside in the Laminar flow ward for 1-3 months.
Measured: 30 days
Biochemical examination
Alanine aminotransferase (0~40U/L), glutamine aminotransferase(<15U/L), alkaline phosphatase (40-150U/L) et al.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start22 Apr 2022
- Primary completion31 Dec 2023 (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 LymphomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yao Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yao Liu, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060080
- Sponsor's protocol ID
- 2023Quick review011
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Professor,CHONGQING UNIVERSITY CANCER HOSPITAL
- ClinicalTrials.gov ID
- NCT06060080
- Acronym / sponsor ID
- 2023Quick review011
- Conditions
- Lymphoma, Multiple Myeloma
- Keywords
- PEG-rhG-CSF, Autologous Hematopoietic Stem Cell, Transplantation, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Yao LiuUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 29 Sep 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.
This study evaluates the effectiveness and safety of PEG-rhG-CSF injection for the reconstruction of neutrophil cells after autologous hematopoietic stem cell transplantation in lymphoma/multiple myeloma patients.
Detailed description
This study is a single-center, open-label clinical trial. Inclusion criteria involve patients with confirmed lymphoma or multiple myeloma receiving autologous hematopoietic stem cell transplantation for the first time. After calculating the sample size, an initial cohort of 40 trial patients is expected to be enrolled. Patients meeting the eligibility criteria will be assigned to receive PEG-rhG-CSF treatment on the second day after hematopoietic stem cell infusion, with a fixed dose of 6 mg. The primary outcome measure of this study is the median time for neutrophil cell reconstruction. Secondary study endpoints include safety indicators of the medication, the duration of neutrophil cell reduction (ANC≤2.0×10^9/L), the number of days patients spend in the laminar flow ward after transplantation, the usage of antibiotics, antifungal, or antiviral drugs, as well as patient expenditures, among other indicators.
Criteria for withdrawal/discontinuation of treatment:
(1) Subjects voluntarily request to withdraw from the trial;(2) Subjects who, although not explicitly requesting withdrawal from the trial, no longer adhere to the trial protocol for treatment and assessments, resulting in loss to follow-up; (3) Subjects with poor compliance who switch treatment regimens midway or use prohibited drugs within the protocol; (4) Subjects who were incorrectly enrolled; (5) Subjects experiencing intolerable allergic reactions or adverse events; (6) Subjects who pass away; (7) Other situations that meet the exclusion criteria arise.
Management of detachment cases:
When patients withdraw from the study due to allergic reactions or adverse events, researchers should take appropriate treatment measures based on the subject's condition. For mid-study withdrawal or loss to follow-up, researchers should actively take measures to complete the final assessment to analyze their efficacy and safety. All dropout cases should be documented in the case report form, and the trial conclusion form should be filled out along with the reasons for the subject dropout.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Study on PEG-rhG-CSF in the Treatment of Lymphoma/Multiple Myeloma | Experimental | Drug: pegylated recombinant human granulocyte-colony stimulating factorIn this study, lymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65, any gender;
- Patients with lymphoma/multiple myeloma requiring autologous hematopoietic stem cell transplantation;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 before transplantation;
- Basic normal function of heart, lungs, liver, and kidneys (no severe heart disease, no severe lung disease; transaminases ≤ 3× upper limit of normal, blood bilirubin ≤ 2.0 mg/dl; blood creatinine ≤ 2× upper limit of normal);
- Pre-transplant blood counts meet the following criteria: ANC (Absolute Neutrophil Count) ≥ 1.5×10^9/L, HGB (Hemoglobin) ≥ 90g/L, PLT (Platelets) ≥ 100×10^9/L;
Key exclusion criteria (9 listed)
- Patients with splenomegaly;
- Individuals who have previously undergone allogeneic or autologous hematopoietic stem cell transplantation;
- HIV antibody-positive, HbsAg-positive, or HCV antibody-positive;
- Impaired liver or kidney function (transaminases >3× ULN or blood bilirubin >2.0 mg/dl; blood creatinine >2× ULN);
- Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on electrocardiogram, or myocardial infarction within the last Six 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 |
|---|---|---|
| pegylated recombinant human granulocyte-colony stimulating factorAlso: PEG-rhG-CSFLymphoma/multiple myeloma patients who meet the inclusion criteria will be administered PEG-rhG-CSF injection at a fixed dose of 6 mg on the second day after hematopoietic stem cell infusion, and the effectiveness and safety of the treatment will be observed. | Drug | Clinical Study on PEG-rhG-CSF in the Treatment of Lymphoma/Multiple Myeloma |
Primary outcome
Median time to neutrophil cell reconstruction
Time frame: 0-21 days
day-based
4 secondary outcomes
Blood Tests
Time frame: 30 days
Duration of absolute neutrophil count (ANC)
Time frame: 30 days
Number of days staying in the laminar flow ward after transplantation
Time frame: 30 days
Biochemical examination
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegylated recombinant human granulocyte-colony stimulating factor in people with Lymphoma and Multiple Myeloma, run by Yao Liu 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 9 inclusion and 9 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 29 Sep 2023. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to neutrophil cell reconstruction (time frame: 0-21 days). 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 29 Sep 2023.