LymphomaPhase 4NCT02905942
PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation
A Phase 4 study testing PEG-rhG-CSF and rhG-CSF in people with Lymphoma, run by Peking University at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of PEG-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
- 96 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2018
- 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
- Patients with age between 18 and 65 years.
- Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
- The collected CD34+ cells≥1×10E6/kg.
- ECOG score ≤2.
- Heart and lung is normal.
- Blood creatinine ≤1.5×ULN.
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- ALT, AST, TBIL ≤2 ×ULN
- Not in pregnancy.
- Written informed consent are acquired.
Who cannot join
- Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
- Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
- Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
- LVEF <55%.
- Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
- Refused to take contraceptive measures during the study period and the subsequent 1 years.
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- Severe mental or neurological disorders.
- Serious heart, lung, central nervous system disorders.
- Sickle cell anemia, hemolytic anemia and other hematologic diseases.
- Participate in other drugs clinical trials 30 days before the screening.
- Other situation that investigators consider as contra-indication for this study.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, 100142
Jun Zhu, MD, +86-10-88196596, zj@bjcancer.org
About this study
Official title: A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-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 on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
Read the detailed description
At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-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 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.
- 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 100μg/kg(bw).For patients more than 45kg, 6mg was suggested.
rhG-CSFDrug
rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day
| 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 control 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: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (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 Peking 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905942
- Sponsor's protocol ID
- CSPC-JYL-20150830
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Randomized Controlled Trial of the Efficacy and Safety of PEG-rhG-CSF After Autologous Hematopoietic Stem Cell Transplantation for Lymphoma Patients
- ClinicalTrials.gov ID
- NCT02905942
- Acronym / sponsor ID
- CSPC-JYL-20150830
- Conditions
- Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- 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 on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.
Detailed description
At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-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 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.
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 control 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 (9 listed)
- Patients with age between 18 and 65 years.
- Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
- The collected CD34+ cells≥1×10E6/kg.
- ECOG score ≤2.
- Heart and lung is normal.
Key exclusion criteria (12 listed)
- Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
- Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
- Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
- LVEF <55%.
- Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
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 100μg/kg(bw).For patients more than 45kg, 6mg was suggested. | Drug | PEG-rhG-CSF |
| rhG-CSFrhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day | Drug | rhG-CSF |
Primary outcome
Time to neutrophil engraftment
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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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.
Jun Zhu principal investigator
Peking University Cancer Hospital & Institute
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, run by Peking University 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 12 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 19 Sep 2016. 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 Jun Zhu, MD (+86-10-88196596, zj@bjcancer.org), 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: 30days). 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 19 Sep 2016.