CTIT-Chemotherapy Induced ThrombocytopeniaPhase 3NCT06440824
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
A Phase 3 study testing Romiplostim N01 and Recombinant Human Thrombopoietin in people with CTIT-Chemotherapy Induced Thrombocytopenia, run by Shandong University.
Trial summary
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTIT-Chemotherapy Induced Thrombocytopenia
- What is being tested?
- Romiplostim N01 and Recombinant Human Thrombopoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Nov 2025
- 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
- Sign a written informed consent form before enrollment;
- Age range from 18 to 75 years old;
- Solid tumors or hematological tumors confirmed by tissue or pathology;
- CTIT patients caused by anti-tumor therapy;
- At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)
- Have not received treatment with Roptistine/Roptistine N01;
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- ECOG PS score: 0-2;
- Platelet value<30 × 109/L;
- Estimated survival time during screening is ≥ 12 weeks;
- Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation;
- Voluntarily participate in this study, sign an informed consent form, and have good compliance.
Who cannot join
- -
- Patients with any of the following conditions are not eligible for inclusion in this study:
- Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
- Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;
- Bone marrow invasion or metastasis;
- Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
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- Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;
- Any history of arterial or venous thrombosis occurring within the first 6 months of screening;
- Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;
- Brain tumors or brain metastases;
- Urgent treatment is required, such as vena cava syndrome and spinal cord compression syndrome;
- Neutrophil absolute value < 1.0 × 109/L, hemoglobin < 80g/L, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy;
- Significant abnormalities in liver function: patients without liver metastasis, ALT/AST>3ULN (upper limit of normal value), TBIL>3ULN； Patients with liver metastasis are present, ALT/AST≥5ULN，TBIL≥5ULN；
- Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula);
- Within the first month prior to screening, patients who have received treatment with loperstine/loperstine N01 or recombinant human thrombopoietin (rhTPO);
- Received platelet transfusion within the first 3 days of randomization;
- Patients who are known or expected to be allergic or intolerant to Roxetine N01 or rhTPO excipients
- HIV infected individuals;
- Pregnant or lactating women;
- Participated in any clinical study of any other investigational drug or device three months prior to screening;
- The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation.
About this study
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
- Being tested
- Romiplostim N01, Recombinant Human Thrombopoietin
- Keywords
- Romiplostim N01，Recombinant Human Thrombopoietin，CTIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
2.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication
Recombinant Human ThrombopoietinDrug
30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 | Experimental | Not described Receives: Drug: Romiplostim N01 |
| Recombinant Human Thrombopoietin | Active comparator | Not described Receives: Drug: Recombinant Human Thrombopoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment
Measured: Within 4 weeks after receiving treatment
Secondary outcomes (6)
The time required for PLT to recover to 50 × 109/L or above after treatment
Measured: up to 8 weeks
The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment
Measured: 2 weeks after receiving treatment
The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment
Measured: 12 weeks after receiving treatment
The lowest platelet count from receiving treatment to the end of treatment
Measured: up to 8 weeks
The proportion of patients receiving platelet transfusion
Measured: through study completion, an average of 5 months
The proportion of restoring anti-tumor treatment for at least 2 cycles without recurrence of CTIT
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTIT-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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440824
- Sponsor's protocol ID
- QLMA-CIT-IIT-001
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 4 Jun 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
- ClinicalTrials.gov ID
- NCT06440824
- Acronym / sponsor ID
- QLMA-CIT-IIT-001
- Keywords
- Romiplostim N01，Recombinant Human Thrombopoietin，CTIT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 4 Jun 2024 (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.
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim N01 | Experimental | Drug: Romiplostim N01 |
| Recombinant Human Thrombopoietin | Active comparator | Drug: Recombinant Human Thrombopoietin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign a written informed consent form before enrollment;
- Age range from 18 to 75 years old;
- Solid tumors or hematological tumors confirmed by tissue or pathology;
- CTIT patients caused by anti-tumor therapy;
- At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)
Key exclusion criteria (21 listed)
- -
- Patients with any of the following conditions are not eligible for inclusion in this study:
- Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
- Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;
- Bone marrow invasion or metastasis;
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 |
|---|---|---|
| Romiplostim N012.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication | Drug | Romiplostim N01 |
| Recombinant Human Thrombopoietin30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication | Drug | Recombinant Human Thrombopoietin |
Primary outcome
The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment
Time frame: Within 4 weeks after receiving treatment
6 secondary outcomes
The time required for PLT to recover to 50 × 109/L or above after treatment
Time frame: up to 8 weeks
The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment
Time frame: 2 weeks after receiving treatment
The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment
Time frame: 12 weeks after receiving treatment
The lowest platelet count from receiving treatment to the end of treatment
Time frame: up to 8 weeks
The proportion of patients receiving platelet transfusion
Time frame: through study completion, an average of 5 months
The proportion of restoring anti-tumor treatment for at least 2 cycles without recurrence of CTIT
Time frame: through study completion, an average of 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romiplostim N01 and Recombinant Human Thrombopoietin in people with CTIT-Chemotherapy Induced Thrombocytopenia, run by Shandong University.
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 21 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment (time frame: Within 4 weeks after receiving treatment). 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 4 Jun 2024.