Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients
Recruiting
Phase 2
Interventional Study
Solid Tumors
Hematological Tumor
Children
Adolescent
Chemotherapy Induced Thrombocytopenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 24
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 potent…
Contacts