Chemotherapy-induced ThrombocytopeniaPhase 2/3NCT05554913
Evaluating the Efficacy and Safety of QL0911 in the Prevention of 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 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments. 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?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 20 Feb 2024
- 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
- Aged ≥18 years old;
- Histopathological or cytological examination confirmed solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), chemotherapy cycle of 21 days, and using of one or more of the following chemotherapy drugs: gemcitabine; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; Anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; Taxa, including paclitaxel, docetaxel, etc.
- The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle, including the chemotherapy drugs and the dosages, without adding or subtracting drugs or dosages;
- At least two platelet counts with an interval of more than 24 hours in the chemotherapy cycle before enrollment was grade 2 or higher thrombocytopenia;
- The platelet count was between 75×10^9/L-150×10^9/L (including both ends) 1 day before chemotherapy or the day of Randomization;
- At the time of screening, the expected survival time is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Who cannot join
- Suffering from other hematopoietic system diseases besides lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndromes, etc.
- Have experienced thrombocytopenia caused by non-tumor chemotherapeutics within 6 months before screening,Including, but not limited to, EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding, etc.
- Brain tumors, brain metastases,bone marrow invasion or bone marrow metastasis;
- Receiving radiotherapy or have received abdominal pelvic or sternum radiotherapy within 3 months;
- Any arterial or venous thrombosis occurred within 6 months before screening;
- Severe cardiovascular disease (e.g., NYHA Heart Function Score Class III-IV), arrhythmias such as atrial fibrillation that increase the risk of thrombosis, coronary stenting, angioplasty, and coronary artery bypass grafting within the previous 6 months were screened;
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- Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 4 weeks before the first administration of the experimental drug;
- Received platelet transfusion within 5 days before randomization/enrollment;
- Received thrombopoietin receptor agonist treatment within 4 weeks, human recombinant thrombopoietin (rhTPO) or rhIL-11 within 4 weeks,other Chinese medicines with the effect of raising blood plate within 1 week before the administration of the experimental drug;
- Used heparin, warfarin, aspirin and other anticoagulant drugs within 7 days before the first dose except for the purpose of sealing the tube;
- Received bone marrow transplantation or stem cell infusion within 1 year before screening;
- Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
- The absolute value of neutrophils in the screening period<1.5×10^9/L, hemoglobin <90g/L;
- Total bilirubin greater than 3X ULN; alanine aminotransferase [ALT] and aspartate aminotransferase [AST] greater than 3X ULN for subjects without liver metastases or greater than or equal to 5X ULN for subjects with liver metastases during screening;
- Serum creatinine concentration ≥1.5ULN or eGFR≤45ml/min (cockcroft-gault);
- Severe drug allergic reactions;
- Used any investigational drug within 3 months before the administration of the experimental drug;
- Planning pregnancy, pregnancy, or suckling period;
- The investigator judged that the patients are not suitable for participating in this trial.
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 the Prevention of Chemotherapy- Induced Thrombocytopenia
To evaluate the efficacy and safety of QL0911 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.
Read the detailed description
For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy and safety of QL0911 . Each subject will be randomly assigned to either Arm A (QL0911) or Arm B (placebo) in 2:1 ratio.The primary objective is to compare the effective rates of the two treatment arms. The study will consist of a screening period of up to 4 weeks, a treatment period of 2 planned cycles of chemotherapy, a follow-up visit of 2 weeks.
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Being tested
- QL0911, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0911Drug
This study is designed to study QL0911 for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for cancer
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| QL0911 | Experimental | The study in a 2:1 randomization ratio(40 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. Receives: Drug: QL0911 |
| Placebo | Placebo comparator | The study in a 2:1 randomization ratio(20 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who had an efficacy response during the double-blind period
Measured: 42 days
Secondary outcomes (3)
Lowest and highest platelet count
Measured: 42 days
Bleeding score(Revised WHO grading system)
Measured: 42 days
Proportion of patients with platelet count < 50×10^9/L per cycle
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start8 Nov 2022
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 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
- NCT05554913
- Sponsor's protocol ID
- QL0911-CIT-301(Part B)
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. 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 the Prevention of Chemotherapy- Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05554913
- Acronym / sponsor ID
- QL0911-CIT-301(Part B)
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 26 Sep 2022 (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 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.
Detailed description
For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy and safety of QL0911 . Each subject will be randomly assigned to either Arm A (QL0911) or Arm B (placebo) in 2:1 ratio.The primary objective is to compare the effective rates of the two treatment arms. The study will consist of a screening period of up to 4 weeks, a treatment period of 2 planned cycles of chemotherapy, a follow-up visit of 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL0911 | Experimental | Drug: QL0911The study in a 2:1 randomization ratio(40 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. |
| Placebo | Placebo comparator | Drug: PlaceboThe study in a 2:1 randomization ratio(20 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years old;
- Histopathological or cytological examination confirmed solid tumor or lymphoma (including NSCLC, breast cancer, bladder cancer, pancreatic cancer, etc.), chemotherapy cycle of 21 days, and using of one or more of the following chemotherapy drugs: gemcitabine; Platinum, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; Anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; Taxa, including paclitaxel, docetaxel, etc.
- The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle, including the chemotherapy drugs and the dosages, without adding or subtracting drugs or dosages;
- At least two platelet counts with an interval of more than 24 hours in the chemotherapy cycle before enrollment was grade 2 or higher thrombocytopenia;
- The platelet count was between 75×10^9/L-150×10^9/L (including both ends) 1 day before chemotherapy or the day of Randomization;
Key exclusion criteria (19 listed)
- Suffering from other hematopoietic system diseases besides lymphoma, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndromes, etc.
- Have experienced thrombocytopenia caused by non-tumor chemotherapeutics within 6 months before screening,Including, but not limited to, EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding, etc.
- Brain tumors, brain metastases,bone marrow invasion or bone marrow metastasis;
- Receiving radiotherapy or have received abdominal pelvic or sternum radiotherapy within 3 months;
- Any arterial or venous thrombosis occurred 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 |
|---|---|---|
| QL0911This study is designed to study QL0911 for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for cancer | Drug | QL0911 |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Proportion of patients who had an efficacy response during the double-blind period
Time frame: 42 days
3 secondary outcomes
Lowest and highest platelet count
Time frame: 42 days
Bleeding score(Revised WHO grading system)
Time frame: 42 days
Proportion of patients with platelet count < 50×10^9/L per cycle
Time frame: 42 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 18 Oct 2024.
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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 8 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 18 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients who had an efficacy response during the double-blind period (time frame: 42 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 18 Oct 2024.