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New hope for young cancer patients: drug may fix Chemo-Related low platelets

NCT ID NCT07043894

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called romiplostim N01 in children, adolescents, and young adults (ages 6-24) with cancer who develop low platelet counts from chemotherapy. The drug is given as a weekly shot to help the body produce more platelets. The goal is to see if it can safely and quickly bring platelet levels back up, which could reduce bleeding risks and help patients complete their cancer treatment. The study involves 50 participants and will monitor for side effects like blood clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
romiplostim N01 (a platelet-boosting drug)
What this could lead to
If it works, this could offer a safe and effective way to quickly restore platelet counts in young cancer patients, reducing bleeding risks and allowing chemotherapy to continue on schedule.
What could go wrong
This is a small, early-phase (Phase 2) study with no comparison group, so results may not be definitive. The drug may not work for everyone and could cause side effects like blood clots or increased bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary participation with signed informed consent. 2. Aged 6-24 years, any gender. 3. ECOG performance status 0-2. 4. Histologically/cytologically confirmed non-myeloid malignancy requiring high-intensity chemotherapy with ≥1 myelosuppressive agent. 5. Patients with potential curative opportunity eligible for standard therapy. 6. Chemotherapy-induced thrombocytopenia (platelets \<75×10⁹/L). 7. Anticipated survival ≥8 months. 8. Planned ≥2 additional chemotherapy cycles (21-/28-day cycles). 9. 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. 10. No participation in other drug trials within 4 weeks. 11. Good compliance with efficacy/safety follow-up per protocol. 12. Absence of severe complications (e.g., active GI bleeding/perforation, jaundice, obstruction, non-cancer fever \>38°C). 13. Ability to comprehend and sign informed consent. Exclusion Criteria: 1. Hematologic disorders (non-CIT etiology): AML, ITP, MDS, MPN, multiple myeloma, etc. 2. Non-CIT thrombocytopenia within 6 months (e.g., chronic liver disease, hypersplenism, infection, hemorrhage). 3. Known hypersensitivity to romiplostim N01 or excipients (cellulose-lactose, L-HPC, magnesium stearate, film coating). 4. Refractory cytopenias: * Hemoglobin \<50 g/L despite RBC/EPO; * ANC \<1.0×10⁹/L despite G-CSF. 5. Pelvic/spinal/large-field radiotherapy within 3 months. 6. Arterial/venous thrombosis within 3 months. 7. Severe cardiovascular disease (NYHA Class III-IV, arrhythmia with thromboembolic risk, post-CABG/stent) within 6 months. 8. Use of rhTPO, rhIL-11, or TPO-RAs (eltrombopag/avatrombopag/hetrombopag) within 2 weeks. 9. Investigator-assessed risks compromising safety/efficacy evaluation.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent Chemotherapy-induced thrombocytopenia Children Hematological tumor Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.