LymphomaNCT05156554
PEG-rhG-CSF Compared With rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
A study testing PEG-rhG-CSF and rhG-CSF in people with Lymphoma, run by Sun Yat-sen University.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- PEG-rhG-CSF and 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
- Dec 2021to Jan 2023
- 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
- Patients with age between 18 and 65 years;
- hematopoietic stem cell transplantation for the first time;
- Lymphoma patients with the requirement for autologous;
- ECOG score ≤2;
- Estimated survival time > 3 months;
- All acute toxicity caused by previous chemotherapy or treatment has been restored; 7.1) The absolute value of neutrophils (>1.5×10^9/L); Hemoglobin (> 90 g/L); 2)Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/min) of serum creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); Serum total bilirubin < 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%);
- 8.Not in pregnancy; 9.Written informed consent are acquired.
Who cannot join
- Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation;
- bone marrow involvement;
- Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators;
- Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators;
- Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction；
- patients in fever of unknown origin before medication（>38℃）；
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- central nervous system involvement;
- Patients that received pelvic radiotherapy;
- patients will received Chemotherapy or radiotherapy under the diaphragm after transplantation ；
- Participation or consideration of participation in another biomedical study during the follow-up period of the present trial;
- Pregnant or lactating women;
- Serious heart, lung, hemorrhagic disease;
- Past psychiatric history; incapacitated or restricted;
- patient's condition increase the risk of receiving the drug treatment or confusion about the toxic reaction；
- Severe intolerance to the growth factor under study, or hypersensitivity to one of their components;
- the patients did not comply with the study;
- Other situation that investigators consider as contra-indication for this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF Compared With rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
Read the detailed description
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 6 mg. Patients in rhG-CSF group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.
- Conditions
- Lymphoma
- Being tested
- PEG-rhG-CSF, rhG-CSF
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg.
rhG-CSFDrug
rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Patients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation. Receives: Drug: PEG-rhG-CSF |
| rhG-CSF | Active comparator | Patients in rhG-CSF group received rhG-CSF day+1 after transplantation. Receives: Drug: rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to neutrophil engraftment
Measured: 30 days
Secondary outcomes (4)
The duration of neutrophilic granulocytopenia
Measured: 30 days
Incidence of febrile neutrophilic granulocytopenia
Measured: 30 days
Time to platelet engraftment and number of platelet transfused to the patient
Measured: 30 days
Adverse Event
Safety
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 posted14 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (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.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
- Investigators
- Huiqiang Huang, professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156554
- Sponsor's protocol ID
- MA-ASCT-II-001
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 14 Dec 2021
- 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 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF Compared With rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
- ClinicalTrials.gov ID
- NCT05156554
- Acronym / sponsor ID
- MA-ASCT-II-001
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Dec 2021 (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 purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
Detailed description
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF compared with rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 6 mg. Patients in rhG-CSF group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSFPatients in PEG-rhG-CSF group received PEG-rhG-CSF day+1 after transplantation. |
| rhG-CSF | Active comparator | Drug: rhG-CSFPatients in rhG-CSF group received rhG-CSF day+1 after transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with age between 18 and 65 years;
- hematopoietic stem cell transplantation for the first time;
- Lymphoma patients with the requirement for autologous;
- ECOG score ≤2;
- Estimated survival time > 3 months;
Key exclusion criteria (17 listed)
- Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation;
- bone marrow involvement;
- Patients with active autoimmune diseases requiring systematic treatment were excluded according to the clinical judgment of the investigators;
- Patients with active infections requiring systematic treatment were excluded according to the clinical judgment of the investigators;
- Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction；
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-CSFPEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 6mg. | Drug | PEG-rhG-CSF |
| rhG-CSFrhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 5μg/kg once per day until the count of neutrophil>0.5×10^9 /L. | Drug | rhG-CSF |
Primary outcome
Time to neutrophil engraftment
Time frame: 30 days
4 secondary outcomes
The duration of neutrophilic granulocytopenia
Time frame: 30 days
Incidence of febrile neutrophilic granulocytopenia
Time frame: 30 days
Time to platelet engraftment and number of platelet transfused to the patient
Time frame: 30 days
Adverse Event
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 14 Dec 2021.
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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.
Huiqiang Huang, professor principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhG-CSF and rhG-CSF in people with Lymphoma, run by Sun Yat-sen University.
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 17 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 14 Dec 2021. 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.
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 Huiqiang Huang, professor (0086-13808885154, huang_sysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to neutrophil engraftment (time frame: 30 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 14 Dec 2021.