Pancytopenia Due to ChemotherapyPhase 4NCT02314273
Effect of rhIL-11 in Patients With Thrombocytopenia for Childhood ALL
A Phase 4 study testing rhIL-11 in people with Pancytopenia Due to Chemotherapy, run by Shanghai Children's Medical Center at 5 sites in China.
Trial summary
The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pancytopenia Due to Chemotherapy
- What is being tested?
- rhIL-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesChina
- Study dates
- Sep 2011to Apr 2014
- 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
- new diagnosis of ALL
- TBIL≤34umol/L，Cr≤120umol/L，a normal EF
- age <18 years
Who cannot join
- patients with uncontrolled infection
- patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Children's Hospital
Beijing, Beijing Municipality
Nanjing Children's Hospital
Nanjing, Jiangsu
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Soochow University Affiliated Children's Hospital
Suzhou, Jiangsu
About this study
Official title: Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.
Read the detailed description
Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group
- Conditions
- Pancytopenia Due to Chemotherapy
- Being tested
- rhIL-11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhIL-11Drug
Also called Recombinant Human Interleukin-11
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL
| Study group | Role | What they receive |
|---|---|---|
| rhIL-11 group | Experimental | patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Receives: Drug: rhIL-11 |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet infusion
frequency of platelet infusion
Measured: 14 days
Secondary outcomes (4)
hemorrhagic tendency
conditions of bleeding
Measured: 14 days
infection
incident of infection during 14d after chemotherapy
Measured: 14 days
remission rate
remission rate during 14d after chemotherapy
Measured: 14 days
platelet Count
recovery of peripheral platelet count
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancytopenia Due to ChemotherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Tang Jingyan, M.D., Study chair, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314273
- Sponsor's protocol ID
- TBK-10-01
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT02314273
- Acronym / sponsor ID
- TBK-10-01
- Conditions
- Pancytopenia Due to Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Dec 2014 (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 goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.
Detailed description
Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhIL-11 group | Experimental | Drug: rhIL-11patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL |
| control group | No intervention | –control group |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- new diagnosis of ALL
- TBIL≤34umol/L，Cr≤120umol/L，a normal EF
- age <18 years
Key exclusion criteria (2 listed)
- patients with uncontrolled infection
- patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
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 |
|---|---|---|
| rhIL-11Also: Recombinant Human Interleukin-11patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL | Drug | rhIL-11 group |
Primary outcome
platelet infusion
Time frame: 14 days
frequency of platelet infusion
4 secondary outcomes
hemorrhagic tendency
Time frame: 14 days
infection
Time frame: 14 days
remission rate
Time frame: 14 days
platelet Count
Time frame: 14 days
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 11 Dec 2014.
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.
Tang Jingyan, M.D. study chair
Shanghai Children's Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhIL-11 in people with Pancytopenia Due to Chemotherapy, run by Shanghai Children's Medical Center at 5 sites 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 3 inclusion and 2 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
platelet infusion (time frame: 14 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 11 Dec 2014.