Chemotherapy-induced ThrombocytopeniaPhase 3NCT01663441
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
A Phase 3 study testing NL201 and rhIL-11 in people with Chemotherapy-induced Thrombocytopenia, run by Beijing Northland Biotech. Co., Ltd. at 5 sites in China.
Trial summary
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- What is being tested?
- NL201 and rhIL-11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2015to Aug 2017
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological verification of malignancy at the time of initial diagnosis；
- Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10^9/L；
- patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
- ECOG ≤2；
- patients to have normal laboratory findings:while white blood count >3.0×10^9/L,platelet count ≥100×10^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
- The estimated life expectancy of the patient was more than 3 months.
Who cannot join
- patients who received total body irradiation；
- patients with childbearing potential；
- patients who were breast-feeding or pregnant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
Read the detailed description
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- NL201, rhIL-11
- Keywords
- Chemotherapy, Thrombocytopenia, Interleukin-11, Platelet
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NL201Drug
Also called mIL-11
mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201Drug
Also called mIL-11
mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
NL201Drug
Also called mIL-11
The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
rhIL-11Drug
Also called Recombinant Human Interleukin-11 for Injection
rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg).
Only for Dose-finding in Phase Ⅲa. Receives: Drug: NL201 |
| A2 | Experimental | Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg).
Only for Dose-finding in Phase Ⅲa. Receives: Drug: NL201 |
| A | Active comparator | Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg).
Only in Phase Ⅲb. Receives: Drug: NL201; Drug: rhIL-11 |
| B | Active comparator | Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）.
Only in Phase Ⅲb. Receives: Drug: NL201; Drug: rhIL-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.
Measured: During 21 days of chemotherapy cycles
Secondary outcomes (4)
Nadir platelet counts
Measured: During 21 days of chemotherapy cycles
Platelet counts at day 21 after the initiation of chemotherapy.
Measured: Day 21 after the initiation of chemotherapy.
Average platelet counts
Measured: During 21 days of chemotherapy cycles
Incidence of thrombocytopenia
Measured: During 21 days of chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMar 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663441
- Sponsor's protocol ID
- NL201-Ⅲ-2012
- Status last verified
- Jul 2017
- First submitted
- 9 Aug 2012
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
- ClinicalTrials.gov ID
- NCT01663441
- Acronym / sponsor ID
- NL201-Ⅲ-2012
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Keywords
- Chemotherapy, Thrombocytopenia, Interleukin-11, Platelet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beijing Northland Biotech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Aug 2012 (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.
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
Detailed description
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: NL201Patients in this treatment group will receive NL201(5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(7.5μg/kg). Only for Dose-finding in Phase Ⅲa. |
| A2 | Experimental | Drug: NL201Patients in this treatment group will receive NL201(7.5μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201(5μg/kg). Only for Dose-finding in Phase Ⅲa. |
| A | Active comparator | Drug: NL201, Drug: rhIL-11Patients in this treatment group will receive NL201（optimal dosing dose）in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive rhIL-11(25μg/kg). Only in Phase Ⅲb. |
| B | Active comparator | Drug: NL201, Drug: rhIL-11Patients in this treatment group will receive rhIL-11(25μg/kg) in the first Chemotherapy cycle.Then，in the second Chemotherapy cycle，receive NL201（optimal dosing dose）. Only in Phase Ⅲb. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histological verification of malignancy at the time of initial diagnosis；
- Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10^9/L；
- patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
- ECOG ≤2；
- patients to have normal laboratory findings:while white blood count >3.0×10^9/L,platelet count ≥100×10^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
Key exclusion criteria (3 listed)
- patients who received total body irradiation；
- patients with childbearing potential；
- patients who were breast-feeding or pregnant
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 |
|---|---|---|
| NL201Also: mIL-11mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy； | Drug | A1, A2 |
| NL201Also: mIL-11mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy； | Drug | A1, A2 |
| NL201Also: mIL-11The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy. | Drug | A, B |
| rhIL-11Also: Recombinant Human Interleukin-11 for InjectionrhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy. | Drug | A, B |
Primary outcome
Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L.
Time frame: During 21 days of chemotherapy cycles
4 secondary outcomes
Nadir platelet counts
Time frame: During 21 days of chemotherapy cycles
Platelet counts at day 21 after the initiation of chemotherapy.
Time frame: Day 21 after the initiation of chemotherapy.
Average platelet counts
Time frame: During 21 days of chemotherapy cycles
Incidence of thrombocytopenia
Time frame: During 21 days of chemotherapy cycles
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 16 Sep 2020.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NL201 and rhIL-11 in people with Chemotherapy-induced Thrombocytopenia, run by Beijing Northland Biotech. Co., Ltd. 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 6 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 16 Sep 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Recovery time of platelet counts from below 100x10^9/L raise to more than 100 x10^9/L. (time frame: During 21 days of chemotherapy cycles). 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 16 Sep 2020.