Solid TumorsPhase 2NCT07043894
Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients
A Phase 2 study testing Romiplostim N01 in people with Solid Tumors and Hematological Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Solid Tumors, Hematological Tumor, Children
- What is being tested?
- Romiplostim N01
- 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
- 25 Dec 2025to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary participation with signed informed consent.
- Aged 6-24 years, any gender.
- ECOG performance status 0-2.
- Histologically/cytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.
- Patients with potential curative opportunity eligible for standard therapy.
- Chemotherapy-induced thrombocytopenia (platelets <75×10⁹/L).
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- Anticipated survival ≥8 months.
- Planned ≥2 additional chemotherapy cycles (21-/28-day cycles).
- Laboratory parameters meeting:
- Renal function: Cr ≤1.5×ULN; Ccr ≥55 mL/min.
- Hepatic function:
- Total bilirubin ≤1.5×ULN; ALT/AST ≤3×ULN;
- For liver metastasis/cholangiocarcinoma: bilirubin ≤3×ULN, transaminases ≤5×ULN.
- No participation in other drug trials within 4 weeks.
- Good compliance with efficacy/safety follow-up per protocol.
- Absence of severe complications (e.g., active GI bleeding/perforation, jaundice, obstruction, non-cancer fever >38°C).
- Ability to comprehend and sign informed consent.
Who cannot join
- Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.
- Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).
- Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).
- Refractory cytopenias:
- Hemoglobin <50 g/L despite RBC/EPO;
- ANC <1.0×10⁹/L despite G-CSF.
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- Pelvic/spinal/large-field radiotherapy within 3 months.
- Arterial/venous thrombosis within 3 months.
- Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG/stent) within 6 months.
- Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag/avatrombopag/hetrombopag) within 2 weeks.
- Investigator-assessed risks compromising safety/efficacy evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Sidan Li, +86-010-87788559, lisidan2006@126.com
About this study
Official title: A Prospective, Multicenter Study on the Efficacy and Safety of Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia (CIT) in Children, Adolescents, and Young Adults (CAYA) With Hematological and Solid Tumors
The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are:
- What proportion of participants achieve platelet count recovery (≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline) within 3 weeks of romiplostim N01 treatment?
- What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag).
Read more
Participants will:
- Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg/kg).
- Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg/kg if platelets <99×10⁹/L, maximum dose 10 µg/kg, stop when target recovery is met).
- Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.
Read the detailed description
This prospective, multicenter, open-label, single-arm Phase II clinical trial investigates the efficacy and safety of romiplostim N01, a thrombopoietin receptor agonist (TPO-RA), for treating chemotherapy-induced thrombocytopenia (CIT) in children, adolescents, and young adults (CAYA) aged 6-24 years with hematologic malignancies or solid tumors. Romiplostim N01 binds to the c-MPL receptor on megakaryocytes and their precursors, activating JAK-STAT and MAPK-ERK signaling pathways to stimulate platelet production. Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Doses are adjusted weekly based on platelet counts: increased by 2 μg/kg if platelets are <50 × 10⁹/L, by 1 μg/kg if 50-99 × 10⁹/L, up to a maximum of 10 μg/kg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹/L or increase by ≥30 × 10⁹/L from baseline.
The study involves 10 site visits over 36 days, including screening (≤14 days), baseline (Day 0), treatment (Days 1, 3, 5, 8, 15), and follow-up (Days 22, 29, 36). Serial assessments include platelet counts (primary efficacy endpoint), hemoglobin, neutrophil levels, vital signs, physical examinations, ECOG performance status, and laboratory evaluations (renal/hepatic function, coagulation). Safety is rigorously monitored using NCI CTCAE v5.0 for adverse events (AEs), WHO bleeding scale for hemorrhage, and active surveillance for thrombosis. Rescue therapies (e.g., platelet transfusions, rhTPO, rhIL-11) are permitted per protocol-specified thresholds. Data are captured electronically (EDC system) with source verification per GCP standards.
Statistical analysis targets 50 participants (factoring in 10% attrition) to achieve 80% power (α=0.05, two-sided) for detecting superiority over historical controls (60.7% response rate for hetrombopag). The Full Analysis Set (FAS) includes all dosed participants, while the Per Protocol Set (PPS) excludes those with major deviations. The primary efficacy endpoint-proportion achieving platelet recovery (≥100 × 10⁹/L or Δ≥30 × 10⁹/L) by Week 3-is analyzed using Clopper-Pearson method for 95% CI, with missing data handled via non-responder imputation. Secondary analyses include time-to-recovery, nadir platelet values, transfusion requirements, and chemotherapy delays (descriptive statistics, Kaplan-Meier for time-to-event). Safety analyses focus on AE incidence, severity, and causality.
Conducted across 12 sites in China (e.g., Chinese Academy of Medical Sciences Cancer Hospital, Beijing Children's Hospital), the trial adheres to ICH-GCP, Declaration of Helsinki, and local regulations, with ethics committee approval and written informed consent. The operational timeline spans from first participant enrollment (July 2025) to study completion (September 2026). This study addresses a critical gap in CIT management for CAYA patients by prospectively evaluating romiplostim's dosing, efficacy, and safety profile in this population, with rigorous risk mitigation for thrombosis and bleeding events.
- Conditions
- Solid Tumors, Hematological Tumor, Children, Adolescent, Chemotherapy Induced Thrombocytopenia
- Being tested
- Romiplostim N01
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Doses are adjusted weekly based on platelet counts: increased by 2 μg/kg if platelets are <50 × 10⁹/L, by 1 μg/kg if 50-99 × 10⁹/L, up to a maximum of 10 μg/kg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹/L or increase by ≥30 × 10⁹/L from baseline.
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 | Experimental | Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Receives: Drug: Romiplostim N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving platelet count recovery to ≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline
Measured: 3 weeks
Secondary outcomes (11)
Median time to platelets ≥100×10⁹/L or ≥30×10⁹/L increase from baseline
Measured: 3 weeks
Nadir platelet count
Measured: 3 weeks
Mean time to platelets ≥100×10⁹/L or ≥30×10⁹/L increase
Measured: 3 weeks
Platelet increase from baseline
Measured: 3 weeks
Median time to peak platelets
Measured: 3 weeks
Median time to nadir platelets
Measured: 3 weeks
Maximum platelet count
Measured: 3 weeks
Frequency of platelet transfusions
Measured: 3 weeks
Volume of platelet transfusions
Measured: 3 weeks
Proportion of patients with Cycle 2 delay ≥4 days due to thrombocytopenia
Measured: 6 weeks
Proportion of patients unable to start Cycle 2 due to thrombocytopenia
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start25 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a multicenter, open-label, single-arm trial. It plans to enroll 50 pediatric and adolescent patients with hematologic or solid tumors who are receiving high-intensity chemotherapy regimens. The study aims to evaluate the efficacy and safety of lusutrombopag N01 in treating chemotherapy-induced thrombocytopenia in this patient population. Patient data from all participating centers will be collected through an Electronic Data Capture (EDC) system. After signing the informed consent form, each subject will be assigned a unique screening number for identification throughout the study period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SIDAN LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Sidan Li, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043894
- Sponsor's protocol ID
- NCCH0011
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study on the Efficacy and Safety of Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia (CIT) in Children, Adolescents, and Young Adults (CAYA) With Hematological and Solid Tumors
- ClinicalTrials.gov ID
- NCT07043894
- Acronym / sponsor ID
- NCCH0011
- Conditions
- Solid Tumors, Hematological Tumor, Children, Adolescent, Chemotherapy Induced Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Jun 2025 (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.
The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are:
- What proportion of participants achieve platelet count recovery (≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline) within 3 weeks of romiplostim N01 treatment?
- What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag).
Participants will:
- Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg/kg).
- Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg/kg if platelets <99×10⁹/L, maximum dose 10 µg/kg, stop when target recovery is met).
- Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.
Detailed description
This prospective, multicenter, open-label, single-arm Phase II clinical trial investigates the efficacy and safety of romiplostim N01, a thrombopoietin receptor agonist (TPO-RA), for treating chemotherapy-induced thrombocytopenia (CIT) in children, adolescents, and young adults (CAYA) aged 6-24 years with hematologic malignancies or solid tumors. Romiplostim N01 binds to the c-MPL receptor on megakaryocytes and their precursors, activating JAK-STAT and MAPK-ERK signaling pathways to stimulate platelet production. Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Doses are adjusted weekly based on platelet counts: increased by 2 μg/kg if platelets are <50 × 10⁹/L, by 1 μg/kg if 50-99 × 10⁹/L, up to a maximum of 10 μg/kg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹/L or increase by ≥30 × 10⁹/L from baseline.
The study involves 10 site visits over 36 days, including screening (≤14 days), baseline (Day 0), treatment (Days 1, 3, 5, 8, 15), and follow-up (Days 22, 29, 36). Serial assessments include platelet counts (primary efficacy endpoint), hemoglobin, neutrophil levels, vital signs, physical examinations, ECOG performance status, and laboratory evaluations (renal/hepatic function, coagulation). Safety is rigorously monitored using NCI CTCAE v5.0 for adverse events (AEs), WHO bleeding scale for hemorrhage, and active surveillance for thrombosis. Rescue therapies (e.g., platelet transfusions, rhTPO, rhIL-11) are permitted per protocol-specified thresholds. Data are captured electronically (EDC system) with source verification per GCP standards.
Statistical analysis targets 50 participants (factoring in 10% attrition) to achieve 80% power (α=0.05, two-sided) for detecting superiority over historical controls (60.7% response rate for hetrombopag). The Full Analysis Set (FAS) includes all dosed participants, while the Per Protocol Set (PPS) excludes those with major deviations. The primary efficacy endpoint-proportion achieving platelet recovery (≥100 × 10⁹/L or Δ≥30 × 10⁹/L) by Week 3-is analyzed using Clopper-Pearson method for 95% CI, with missing data handled via non-responder imputation. Secondary analyses include time-to-recovery, nadir platelet values, transfusion requirements, and chemotherapy delays (descriptive statistics, Kaplan-Meier for time-to-event). Safety analyses focus on AE incidence, severity, and causality.
Conducted across 12 sites in China (e.g., Chinese Academy of Medical Sciences Cancer Hospital, Beijing Children's Hospital), the trial adheres to ICH-GCP, Declaration of Helsinki, and local regulations, with ethics committee approval and written informed consent. The operational timeline spans from first participant enrollment (July 2025) to study completion (September 2026). This study addresses a critical gap in CIT management for CAYA patients by prospectively evaluating romiplostim's dosing, efficacy, and safety profile in this population, with rigorous risk mitigation for thrombosis and bleeding events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a multicenter, open-label, single-arm trial. It plans to enroll 50 pediatric and adolescent patients with hematologic or solid tumors who are receiving high-intensity chemotherapy regimens. The study aims to evaluate the efficacy and safety of lusutrombopag N01 in treating chemotherapy-induced thrombocytopenia in this patient population. Patient data from all participating centers will be collected through an Electronic Data Capture (EDC) system. After signing the informed consent form, each subject will be assigned a unique screening number for identification throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Romiplostim N01 | Experimental | Drug: Romiplostim N01Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Voluntary participation with signed informed consent.
- Aged 6-24 years, any gender.
- ECOG performance status 0-2.
- Histologically/cytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent.
- Patients with potential curative opportunity eligible for standard therapy.
Key exclusion criteria (11 listed)
- Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc.
- Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage).
- Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating).
- Refractory cytopenias:
- Pelvic/spinal/large-field radiotherapy within 3 months.
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 N01Participants receive weekly subcutaneous injections of romiplostim N01 (250 μg/vial; Qilu Pharmaceutical) starting at 2 μg/kg. Doses are adjusted weekly based on platelet counts: increased by 2 μg/kg if platelets are <50 × 10⁹/L, by 1 μg/kg if 50-99 × 10⁹/L, up to a maximum of 10 μg/kg. Treatment continues for up to 2 weeks but stops early if platelets reach ≥100 × 10⁹/L or increase by ≥30 × 10⁹/L from baseline. | Drug | Romiplostim N01 |
Primary outcome
Proportion of patients achieving platelet count recovery to ≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline
Time frame: 3 weeks
11 secondary outcomes
Median time to platelets ≥100×10⁹/L or ≥30×10⁹/L increase from baseline
Time frame: 3 weeks
Nadir platelet count
Time frame: 3 weeks
Mean time to platelets ≥100×10⁹/L or ≥30×10⁹/L increase
Time frame: 3 weeks
Platelet increase from baseline
Time frame: 3 weeks
Median time to peak platelets
Time frame: 3 weeks
Median time to nadir platelets
Time frame: 3 weeks
Maximum platelet count
Time frame: 3 weeks
Frequency of platelet transfusions
Time frame: 3 weeks
Volume of platelet transfusions
Time frame: 3 weeks
Proportion of patients with Cycle 2 delay ≥4 days due to thrombocytopenia
Time frame: 6 weeks
Proportion of patients unable to start Cycle 2 due to thrombocytopenia
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Sidan Li principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim N01 in people with Solid Tumors and Hematological Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 17 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidan Li (+86-0316-5917421, lisidan2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving platelet count recovery to ≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline (time frame: 3 weeks). 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 7 May 2026.