Lymphoma, Non-HodgkinPhase 4NCT04083079
Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
A Phase 4 study testing PEG-rhG-CSF and rhG-CSF in people with Lymphoma, Non-Hodgkin and Granulocyte Colony-Stimulating Factor, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Granulocyte Colony-Stimulating Factor, Cost-Benefit Analysis
- What is being tested?
- PEG-rhG-CSF and rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years
- histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
- plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
- KPS ≥70
- plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
- absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood cell count≥3.0×109/L，without bleeding signs
Show all 10Show fewer
- adquate liver and renal function as protocol discribed
- no serious cardiovascular disease as protocol discribed
- under good mental conditions and informed consented
- potential benefit for subjects based on investigators' decision
Who cannot join
- history of hematopoetic stem cell transplantationor organ transplantation
- uncontrollable infection
- allergic to study drugs or ingredients
- accepted any other investigational drug or participated another interventional study within 30 days during screening period
- other uncontrollable conditions judged by the investigator
- breast-feeding , pregnant or plan to be pregnant during study observation period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, Shanghai Municipality, 200025
Pengpeng XU, MD, PhD, 86-21-64370045 ext. 610707, xpproc@msn.com
Weili ZHAO, MD, PhD
About this study
Official title: Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.
- Being tested
- PEG-rhG-CSF, rhG-CSF
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
rhG-CSFDrug
Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF cohort | Experimental | PEG-rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle for only once.
Dosage: 6mg for weight ≥45kg，3mg for weight <45kg, subcutaneous injection Receives: Drug: PEG-rhG-CSF |
| rhG-CSF cohort | Experimental | rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle until absolute neutrophil count ≥2×10^9/L.
rhG-CSF treatment will be given when there is neutropenia until absolute neutrophil count ≥2×10^9/L.
Dosage: 5μg/kg/d, subcutaneous injection Receives: Drug: rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Effectiveness ratio
A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact
Measured: 1 year
Secondary outcomes (9)
Cost-Effectiveness ratio
A comparison of the different strategies based on the cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact
Measured: 1 year
Sensitivity analysis
A sensitivity analysis is a way of examining Sensitivity to Change in results due to changes in the parameter values applied within a certain scope.
Measured: 1 year
Incidence of febrile neutropenia
Incidence of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle
Measured: 1 year
Duration time of febrile neutropenia
Duration time of febrile neutropenia （i.e. absolute neutrophil count<0.5×10^9/L and temperature ≥38℃）in each cycle
Measured: 1 year
Incidence of grade 3-4 neutropenia
Incidence of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle
Measured: 1 year
Duration time of grade 3-4 neutropenia
Duration time of grade 3-4 neutropenia（i.e. absolute neutrophil count<1×10^9/L）in each cycle
Measured: 1 year
Relative dosage intensity
comparison between planned and actual chemotherapy dosage in each cycle
Measured: 1 year
Usage rate of antibiotics
Usage rate of antibiotics during study period
Measured: 1 year
Adverse events
incidence and severity of adverse events during study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083079
- Sponsor's protocol ID
- PEG-rhG-CSF-01
- Status last verified
- Sep 2019
- First submitted
- 26 Aug 2019
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
- ClinicalTrials.gov ID
- NCT04083079
- Acronym / sponsor ID
- PEG-rhG-CSF-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 10 Sep 2019 (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 is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF cohort | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle for only once. Dosage: 6mg for weight ≥45kg，3mg for weight <45kg, subcutaneous injection |
| rhG-CSF cohort | Experimental | Drug: rhG-CSFrhG-CSF primary/secondary prevention will be given 24-72 hours after each cycle until absolute neutrophil count ≥2×10^9/L. rhG-CSF treatment will be given when there is neutropenia until absolute neutrophil count ≥2×10^9/L. Dosage: 5μg/kg/d, subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-65 years
- histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
- plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
- KPS ≥70
- plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
Key exclusion criteria (6 listed)
- history of hematopoetic stem cell transplantationor organ transplantation
- uncontrollable infection
- allergic to study drugs or ingredients
- accepted any other investigational drug or participated another interventional study within 30 days during screening period
- other uncontrollable conditions judged by the investigator
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-CSFPatients will be given PEG-rhG-CSF for primary/secondary prevention each cycle. | Drug | PEG-rhG-CSF cohort |
| rhG-CSFPatients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle. | Drug | rhG-CSF cohort |
Primary outcome
Incremental Cost-Effectiveness ratio
Time frame: 1 year
A comparison of the different strategies based on the incremental cost-effectiveness ratio (ICER), which is defined by the difference in costs between interventions, divided by the difference in their measured impact
9 secondary outcomes
Cost-Effectiveness ratio
Time frame: 1 year
Sensitivity analysis
Time frame: 1 year
Incidence of febrile neutropenia
Time frame: 1 year
Duration time of febrile neutropenia
Time frame: 1 year
Incidence of grade 3-4 neutropenia
Time frame: 1 year
Duration time of grade 3-4 neutropenia
Time frame: 1 year
Relative dosage intensity
Time frame: 1 year
Usage rate of antibiotics
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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 Phase 4 study testing PEG-rhG-CSF and rhG-CSF in people with Lymphoma, Non-Hodgkin and Granulocyte Colony-Stimulating Factor, run by Ruijin 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 10 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 10 Sep 2019. 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?
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 Weili Zhao, PhD (+86 021 6437045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-Effectiveness ratio (time frame: 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 10 Sep 2019.