Study of bleomycin and OK-432 combined scletotherapy for LMs

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs031180265
• Date of registration: 13/03/2019
• Prospective Registration: No
• Primary sponsor: Fujino Akihiro
• Public title: Study of bleomycin and OK-432 combined scletotherapy for LMs
• Scientific title: Clinical study of bleomycin and OK-432 combined local injection sclerotherapy for intractable lymphatic malformations
• Date of first enrolment: 10/08/2016
• Target sample size: 21
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs031180265
• Study type: Interventional
• Study design: single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Akihiro Fujino
• Affiliation: National Center for Child Health and Development

• Name: Akihiro Fujino
• Affiliation: National Center for Child Health and Development

Key inclusion & exclusion criteria

Inclusion criteria: Patients requiring treatment in the National Center for Child Health and Development, diagnosed as lymphangioma (lymphatic malformation, common and cystic lymphatic malformation) or other lymphatic disease with similar pathological tissue.
Among the above-mentioned subject, patients satisfying the following conditions A and B, and having understood and agreed to the research by document, will be included.
Condition A; satisfying the following condition a or b.
a; spongy lesions remaining after the OK-432 therapy in the past
b; spongy lesion untreated with sclerotherapy and expected of no efficacy of OK-432
Condition B; surgical resection is difficult to apply.
Exclusion criteria: Patients with any of the following diseases will be excluded.
Severe lung dysfunction, lung fibrosis lesions and significant lung lesions, history of hypersensitivity to bleomycin hydrochloride and similar compounds to the (peplomycin), severe renal dysfunction, severe heart disease, and history of radiation to the chest and the periphery.

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Both

Health Condition(s) or Problem(s) studied

D18.1

lymphangioma, lymphatic malformation,

Lymphangioma (lymphatic malformation, common or cystic lymphatic malformation), and other lymphatic
lymphangioma, lymphatic malformation,

Intervention(s)

"OK-432 and bleomycin slolution" (0.05 kE / mL and 0.5 mg / mL, respectively) will be injected into the lesion with water-soluble contrast agent Maximum dose of bleomycin is 10 mg /dose and 5 mg/kgBW.Cumulative maximum dose in repeated treatment is 10 mg/kgBW

Bleomycin, OK-432, sclerotherapy

Primary Outcome(s)

The proportion of subjects that the volume of therapeutic target area in the lesion is reduced 30% or more

Secondary Outcome(s)

Appearance, degree of uplift due to lesions, clinical symptoms such as lymph leakage and bleeding, pain, and frequency of fever / redness,the subjects' impression of their improvement and their degree of satisfaction. Changes in the lung shadows on chest X-ray.

Secondary ID(s)

UMIN000023437

Source(s) of Monetary Support

Japan Agency for Medical Research and Development

Ministry of Health, Labour and Welfare

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Certified Review Board of National Center for Child Health and Development

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 31/03/2023
• Date Completed: 21/09/2022