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New treatment option for Solid Tumors
Official title Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients
ClinicalTrials.gov ID: NCT07043894
What this study is testing
What is Romiplostim N01?
Romiplostim N01 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 24
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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).
- 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 how well it works/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.
- 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.
- 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/how well it works evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.