Alpelisib for Lymphatic Malformations with PIK3CA Mutation

We are studying whether alpelisib can improve symptoms and imaging results in adults and children with lymphatic malformations caused by a PIK3CA mutation. Participants will be compared to those receiving a placebo to assess the treatment's effectiveness.

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Alpelisib
Alpelisib is a substance that targets a cancer growth pathway to treat certain breast cancers with specific gene mutations.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Byl719

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Cliniques Universitaires Saint-Luc
#3001: Centre de malformations vasculaires congenitales
Sint-Stevens-Woluwe, Belgium
Pellegrin Hospital
3102: Unité de Dermatologie Pédiatrique
Bordeaux, France
Hospices Civils De Lyon
3101: Hôpital Femme Mère Enfant Département Médical
Bron, France

Sponsor: Novartis Pharma AG
Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.