Using Bleomycin for treating lymphatic malformations in children
Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
This study is testing whether different strengths of Bleomycin can safely treat lymphatic malformations in children under 14 that can't be removed with surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06437158 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Bleomycin in the sclerotherapy of lymphatic malformations (LMs) in pediatric patients. The study aims to compare the efficacy and safety of different concentrations of Bleomycin, which is an anticancer drug, in treating LMs that cannot be surgically removed. LMs are vascular anomalies that can cause significant symptoms and complications, and sclerotherapy offers a less invasive alternative to surgery. The trial will enroll participants under 14 years of age with rapidly progressing LMs that have been confirmed through imaging.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 14 years old with symptomatic lymphatic malformations that cannot be surgically resected.
Not a fit: Patients with slowly growing lymphatic malformations that do not present obvious symptoms or dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing lymphatic malformations in children.
How similar studies have performed: Other studies have shown promising results using Bleomycin for sclerotherapy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants less than 14 years of age at the time of informed consent/assent form was signed. * Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them. * Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy. Exclusion Criteria: * Penicillin allergy. * Vascular tumors or combined vascular malformations. * Participants who may have had surgical or sclerotherapy treatment by other hardeners. * LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely.
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Yi Ji, Ph.D.
- Email: jijiyuanyuan@163.com
- Phone: +8618980606865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.