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

Study acronym: RAPAMALYMPH
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Feb 2026 to Feb 2027v9
  2. Primary and study completion dates: Feb 2025 to Feb 2026v8
  3. Primary and study completion dates: Feb 2022 to Feb 2025
    • Eligibility criteria expanded, about 10 words
    v7
  4. Study sites: 1 to 2v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2018 to Jun 25, 2018
    v4
  2. Start date: Mar 2018 to Sep 2018v3
  3. Start date: Sep 2017 to Mar 2018
    • Primary and study completion dates: Aug 2021 to Feb 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03243019
Lead Sponsor University Hospital, Lille
Collaborators: Ministry of Health, France
Conditions
(from sponsor)		 Lymphatic Malformation, Pediatric
Related terms Lymphatic Abnormalities
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov