Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

NCT06437158 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-12-19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

Conditions

Lymphatic Malformation

Keywords

Lymphatic Malformation; Bleomycin; Sclerotherapy; Intracystic injection; High-dose concentrations; Low-dose concentrations

Outcome Measures

Primary Outcomes (1)

• Changes of Volume

  Changes of Volume is defined as follows: a complete (90%-100% reduction in LMs volume), substantial (60%-89% reduction in LMs volume), intermediate (20%-59% reduction in LMs volume), or no (\< 20% reduction in LMs volume) response 3 to 6 months post-therapy as assessed by imaging.

  3 to 6 months post-therapy

Secondary Outcomes (5)

• Score of Pain

  3 to 6 months post-therapy

• Global Efficacy

  3 to 6 months post-therapy

• Score of Quality of Life

  3 to 6 months post-therapy

• Number of Participants with Efficacy

  3 to 6 months post-therapy

• Number of Participants with Safety

  3 to 6 months post-therapy

Study Arms (2)

Low-dose Concentrations (1mg/ml) of Bleomycin

EXPERIMENTAL

In this arm, patients with lymphatic malformations were treated by intracapsular injection with low-dose concentrations (1mg/ml) of Bleomycin.

Drug: Bleomycin

High-dose Concentrations (2mg/ml) of Bleomycin

EXPERIMENTAL

In this arm, patients with lymphatic malformations were treated by intracapsular injection with high-dose concentrations (2mg/ml) of Bleomycin.

Drug: Bleomycin

Interventions

Bleomycin DRUG

To validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients

Also known as: Zeocin

High-dose Concentrations (2mg/ml) of Bleomycin; Low-dose Concentrations (1mg/ml) of Bleomycin

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (3)

• Sun J, Wang C, Li J, Song D, Guo L. The efficacy of bleomycin sclerotherapy in the treatment of lymphatic malformations: a review and meta-analysis. Braz J Otorhinolaryngol. 2023 Jul-Aug;89(4):101285. doi: 10.1016/j.bjorl.2023.101285. Epub 2023 Jun 29.

  PMID: 37423005 RESULT

• De Maria L, De Sanctis P, Balakrishnan K, Tollefson M, Brinjikji W. Sclerotherapy for lymphatic malformations of head and neck: Systematic review and meta-analysis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):154-164. doi: 10.1016/j.jvsv.2019.09.007. Epub 2019 Nov 14.

  PMID: 31734224 RESULT

• Wu Z, Zou Y, Fu R, Jin P, Yuan H. A nomogram for predicting sclerotherapy response for treatment of lymphatic malformations in children. Eur J Med Res. 2022 Oct 21;27(1):209. doi: 10.1186/s40001-022-00844-3.

  PMID: 36271467 RESULT

MeSH Terms

Conditions

Lymphatic Abnormalities

Interventions

Bleomycin; Zeocin

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yi Ji, Ph.D.

CONTACT

+8618980606865; jijiyuanyuan@163.com

Min Yang, M.D.

CONTACT

+8615928411140; hx2014bsym@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: May 31, 2024
• Study Start: March 8, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

CN (1)