Actively Recruiting

Phase 2
Age: 0 - 18Years
All Genders
NCT03243019

Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations

Led by University Hospital, Lille · Updated on 2025-12-16

28

Participants Needed

2

Research Sites

396 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period. The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.

CONDITIONS

Official Title

Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient from 0 to 18 years of age with poly-cystic suprahyoid or mediastinal lymphatic malformation
  • Presence of chronic pain or respiratory or swallowing impairment with a CDS score less than 8
  • Curative treatment is not possible or has high risk of morbidity, mortality, functional or cosmetic impairment
  • Karnofsky score over 50% (for patients older than 10 years) or Lansky score over 50% (for patients 10 years or younger)
  • Blood tests showing neutrophils count ≥ 1.0 x 10^9/L, platelets count ≥ 100 x 10^9/L, hemoglobin ≥ 8 g/dL, bilirubin ≤ 1.5 times upper limit of normal, transaminases less than 2.5 times upper limit of normal, serum albumin ≥ 2 g/dL, LDL cholesterol less than 160 mg/dL, triglycerides less than 150 mg/dL
  • Negative pregnancy test if applicable
  • Social security affiliation
  • At least 2 months since any previous procedure on the malformation
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Use of other immunosuppressive therapy or long-term corticosteroid therapy without a 28-day washout period
  • Renal failure
  • Liver failure
  • Digestive diseases causing poor absorption of Rapamycin
  • Uncontrolled or severe infections
  • Need for medications that interfere with CYP3A4 enzyme activity including rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin, diltiazem, verapamil, nicardipine, clotrimazole, fluconazole, troleandomycin, bromocriptine, cimetidine, danazol, protease inhibitors, cisapride, metoclopramide
  • Concurrent treatment with mTOR inhibitors
  • Allergy to peanuts or soy
  • Inability to provide informed consent
  • No social security affiliation
  • Refusal to sign consent or participate
  • Current pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hôpital Jeanne de Flandres, CHU

Lille, France

Actively Recruiting

2

Hu Robert Debre Aphp - Paris

Paris, France

Actively Recruiting

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Research Team

P

Pierre Fayoux, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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