Acute Lymphoid LeukemiaPhase 4NCT02953730
The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
A Phase 4 study testing PEG-rhG-CSF in people with Acute Lymphoid Leukemia, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Lymphoid Leukemia
- What is being tested?
- PEG-rhG-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jun 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age≤18 years old, gender no limited.
- Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
- Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
- Previously not received radiotherapy.
- Karnofsky Performance Scores ( KPS)≥60.
- The expected survival time was >3 months.
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- Neutropenia or agranulocytosis, no bleeding tendency.
- No significant cardiac dysfunction or metabolic disease.
- TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） < 2.5×ULN（upper limit of normal）.
- BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）<1.5×ULN.
- Written informed consent are acquired.
Who cannot join
- With a history of systemic radiotherapy.
- Infection difficult to control, the body temperature ≥ 38℃.
- Other situation that investigators consider as contra-indication for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
- Conditions
- Acute Lymphoid Leukemia
- Being tested
- PEG-rhG-CSF
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Not described Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak concentration(Cmax)
Measured: 1 year
elimination half life(t 1/2kel)
Measured: 1 year
area under the curve(AUC)
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 posted3 Nov 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofan Zhu, Chinese Academy of Medical Sciences
- Investigators
- Xiaofan Zhu, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953730
- Sponsor's protocol ID
- CSPC-JYL-05-01
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02953730
- Acronym / sponsor ID
- CSPC-JYL-05-01
- Conditions
- Acute Lymphoid Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 3 Nov 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 trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSF |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age≤18 years old, gender no limited.
- Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
- Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
- Previously not received radiotherapy.
- Karnofsky Performance Scores ( KPS)≥60.
Key exclusion criteria (3 listed)
- With a history of systemic radiotherapy.
- Infection difficult to control, the body temperature ≥ 38℃.
- Other situation that investigators consider as contra-indication for this 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-CSF | Drug | PEG-rhG-CSF |
Primary outcome
peak concentration(Cmax)
Time frame: 1 year
elimination half life(t 1/2kel)
Time frame: 1 year
area under the curve(AUC)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
Xiaofan Zhu, MD principal investigator
Chinese Academy of Medical Sciences
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 in people with Acute Lymphoid Leukemia, run by Chinese Academy of Medical Sciences 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak concentration(Cmax) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 3 Nov 2016.