Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations

Launched by SOHAG UNIVERSITY · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called sirolimus to treat certain types of lymphatic and vascular malformations, which are growths made up of blood vessels and lymphatic tissue. These conditions can be challenging to treat, especially when they are small and deeply embedded in tissues. The trial aims to see if sirolimus, which has shown promise in previous treatments, is effective for children aged 6 months to 12 years who have not responded to other treatments, including medications and surgeries.

To be eligible for this trial, children must be diagnosed with either microcystic or mixed lymphatic malformations and have already tried other treatments without success. Participants will receive sirolimus and will be monitored for its effects. It's important to note that this trial is not for children with other types of lymphatic malformations or those with certain health issues, such as active infections or severe allergic reactions to sirolimus. Families interested in this trial can expect close care and regular check-ups to assess how well the treatment is working.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • from age 6 months to 12 years , not before 6 months to complete their vaccination program \& maturation of hepatic enzymes .
• • Patients diagnosed with microcystic \& mixed Lymphatic malformations .
• • After failure of other lines of treatment as regard propranolol , steroid for infantile haemangiomas \& Vascular malformations and lymphovascular malformations .
• • After failure of surgical excision \& injection of bleomycin of Lympho-vascular malformations
• Exclusion Criteria:
• • Macrocystic Lymphatic malformations \& high flow vascular malformations like arterio-venous malformations .
• • An active infection that requires systemic treatment during the attack .
• • Side effects of the drug as ( history of an allergic reaction to sirolimus or patients who develop severe allergic reaction to drug during treatment , hyperlipidemia , leucopenia , etc... )
• • Chronic liver or kidney disease or on chronic drug treatment as (steroids, interferon or chemotherapeutic agents) .
• • An immunodeficiency condition such as a human immunodeficiency viral infection or primary immunodeficiency disease.
• • Patients who received drug less than 6 months duration .