Chemotherapy-induced ThrombocytopeniaPhase 2/3NCT05851027
Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia
A Phase 2/3 study testing QL0911 in people with Chemotherapy-induced Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of QL0911 in Chemotherapy- Induced Thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- What is being tested?
- QL0911
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to 10 Sep 2021
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old when signing the informed consent form;
- Histopathological or cytological examination, confirmed as solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), the chemotherapy cycle is 21 days or 28 days, and one or more of the following chemotherapy drugs are needed: anti-metabolic drugs, including gemcitabine, etc.; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc. Anthracyclines, including adriamycin, daunorubicin, epirubicin, etc. Alkylating agent, including cyclophosphamide, ifosfamide, etc. Other cytotoxic chemotherapy drugs that can cause thrombocytopenia;
- In the last regular chemotherapy cycle, the subject had a decrease in platelet count below 75× 109/L;
- Platelet count ≤ 200× 109/L one day before chemotherapy;
- The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles (at least 1 cycle in PartA);
- According to the score standard of physical fitness of the Eastern Cancer Cooperative Group (ECOG), it is 0-2;
- Fully understand and abide by the requirements of this study, and sign the informed consent form voluntarily.
Who cannot join
- Suffering from other hematopoietic diseases except lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
- Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
- Bone marrow invasion or bone marrow metastasis occurs;
- Being receiving radiotherapy or having received abdominal or pelvic radiotherapy within 3 months;
- There have been any arterial or venous thrombosis events within 6 months before screening;
- Screening patients with severe cardiovascular disease (NYHA cardiac function score III-IV) and arrhythmia that increases the risk of thrombosis, such as atrial fibrillation, after coronary stent implantation, angioplasty and coronary artery bypass grafting;
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- Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening;
- Received platelet transfusion within 2 days before randomization;
- Patients have been treated with thrombopoietin receptor agonists (such as romistine and itrapoppa) or human recombinant thrombopoietin (rhTPO) or rhIL-11 within 4 weeks before the first administration;
- Anticoagulant drugs such as heparin, warfarin and aspirin have been used within 7 days before the first administration;
- Received bone marrow transplantation or stem cell infusion within one year before screening;
- Patients with chronic hepatitis B or hepatitis C in active period, and patients with positive antibodies to human immunodeficiency virus;
- The absolute value of neutrophils in the screening period is less than 1.5× 109/L, and hemoglobin is less than 90g/L;
- The total bilirubin in the screening period is more than 3 times the upper limit of the normal range; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were higher than the upper limit of normal range by 3 times. For patients with liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≥ 5 times the upper limit of the normal range;
- Blood creatinine concentration ≥1.5ULN or EGFR ≤ 60 ml/min;
- patients with severe drug allergic reaction;
- Patients who have used any research drugs (excluding vitamins and minerals) within 3 months before the first administration;
- Patients who plan pregnancy, pregnancy or lactation;
- The researcher judges the patients who are not suitable for this experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection (QL0911) in Chemotherapy- Induced Thrombocytopenia
To evaluate the efficacy and safety of QL0911 in Chemotherapy- Induced Thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of chemotherapy.
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- QL0911
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0911Drug
Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| QL0911 Group 1 | Experimental | Starting dose 1μg/kg；PLT 100~200×10^9/L Receives: Drug: QL0911 |
| QL0911 Group 2 | Experimental | Starting dose 2μg/kg；PLT 100~200×10^9/L Receives: Drug: QL0911 |
| QL0911 Group 3 | Experimental | Starting dose 2μg/kg；PLT <100×10^9/L Receives: Drug: QL0911 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration.
Measured: 21 days
The effective response rate of QL0911 on the 28th day (28-days chemotherapy cycle) after administration.
Measured: 28 days
Secondary outcomes (2)
Changes of platelet count from baseline in each visit(21-days chemotherapy cycle)
Measured: 21 days
Changes of platelet count from baseline in each visit(28-days chemotherapy cycle)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start15 Jan 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
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.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851027
- Sponsor's protocol ID
- QL0911-CIT-301(PartA）
- Status last verified
- Apr 2023
- First submitted
- 23 Apr 2023
- Last updated
- 9 May 2023
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection (QL0911) in Chemotherapy- Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05851027
- Acronym / sponsor ID
- QL0911-CIT-301(PartA）
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 9 May 2023 (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.
To evaluate the efficacy and safety of QL0911 in Chemotherapy- Induced Thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QL0911 Group 1 | Experimental | Drug: QL0911Starting dose 1μg/kg；PLT 100~200×10^9/L |
| QL0911 Group 2 | Experimental | Drug: QL0911Starting dose 2μg/kg；PLT 100~200×10^9/L |
| QL0911 Group 3 | Experimental | Drug: QL0911Starting dose 2μg/kg；PLT <100×10^9/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old when signing the informed consent form;
- Histopathological or cytological examination, confirmed as solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), the chemotherapy cycle is 21 days or 28 days, and one or more of the following chemotherapy drugs are needed: anti-metabolic drugs, including gemcitabine, etc.; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc. Anthracyclines, including adriamycin, daunorubicin, epirubicin, etc. Alkylating agent, including cyclophosphamide, ifosfamide, etc. Other cytotoxic chemotherapy drugs that can cause thrombocytopenia;
- In the last regular chemotherapy cycle, the subject had a decrease in platelet count below 75× 109/L;
- Platelet count ≤ 200× 109/L one day before chemotherapy;
- The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles (at least 1 cycle in PartA);
Key exclusion criteria (19 listed)
- Suffering from other hematopoietic diseases except lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
- Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
- Bone marrow invasion or bone marrow metastasis occurs;
- Being receiving radiotherapy or having received abdominal or pelvic radiotherapy within 3 months;
- There have been any arterial or venous thrombosis events within 6 months before screening;
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 |
|---|---|---|
| QL0911Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. | Drug | QL0911 Group 1, QL0911 Group 2, QL0911 Group 3 |
Primary outcome
The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration.
Time frame: 21 days
The effective response rate of QL0911 on the 28th day (28-days chemotherapy cycle) after administration.
Time frame: 28 days
2 secondary outcomes
Changes of platelet count from baseline in each visit(21-days chemotherapy cycle)
Time frame: 21 days
Changes of platelet count from baseline in each visit(28-days chemotherapy cycle)
Time frame: 28 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 9 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QL0911 in people with Chemotherapy-induced Thrombocytopenia, run by Qilu Pharmaceutical Co., Ltd. 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 7 inclusion and 19 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 9 May 2023. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration. (time frame: 21 days). The study lists 2 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 9 May 2023.