NCT03658967: AdeLE

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)

Completed Phase 2 Last updated 9 July 2025

What this trial tests

Phase 2 trial testing Lymfactin® (1x10E11 vp) in Secondary Lymphedema in 39 participants. Completed in 23 October 2024.

Timeline

7 June 2018

Primary endpoint
16 December 2019

23 October 2024

Quick facts

Lead sponsor	Herantis Pharma Plc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	7 June 2018
Primary completion	16 December 2019
Estimated completion	23 October 2024
Sites	5 locations across Sweden, Finland

Drugs / interventions tested

• Lymfactin® (1x10E11 vp) — full drug profile →
• Placebo

Conditions studied

• Secondary Lymphedema — all drugs for Secondary Lymphedema →

Sponsor

Herantis Pharma Plc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Secondary Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in the prevention and treatment of breast cancer-related lymphedema.
   Donahue PMC, MacKenzie A, Filipovic A, Koelmeyer L. · · 2023 · cited 85× · PMID 37103598 · DOI 10.1007/s10549-023-06947-7
2. Nucleoside-modified VEGFC mRNA induces organ-specific lymphatic growth and reverses experimental lymphedema.
   Szőke D, Kovács G, Kemecsei É, Bálint L, et al · · 2021 · cited 41× · PMID 34103491 · DOI 10.1038/s41467-021-23546-6
3. Pharmacological Treatment of Secondary Lymphedema.
   Brown S, Dayan JH, Coriddi M, Campbell A, et al · · 2022 · cited 28× · PMID 35145417 · DOI 10.3389/fphar.2022.828513
4. Adenoviral vectors for cardiovascular gene therapy applications: a clinical and industry perspective.
   Jt S, M H, Wam B, Ac B, et al · · 2022 · cited 22× · PMID 35606652 · DOI 10.1007/s00109-022-02208-0
5. The Future of Lymphedema: Potential Therapeutic Targets for Treatment.
   Brown S, Campbell AC, Kuonqui K, Sarker A, et al · · 2023 · cited 15× · PMID 37359311 · DOI 10.1007/s12609-023-00491-5
6. Therapeutic Lymphangiogenesis Is a Promising Strategy for Secondary Lymphedema.
   Shimizu Y, Che Y, Murohara T. · · 2023 · cited 14× · PMID 37175479 · DOI 10.3390/ijms24097774
7. Radiation therapy attenuates lymphatic vessel repair by reducing VEGFR-3 signalling.
   Pillay V, Shukla L, Herle P, Maciburko S, et al · · 2023 · cited 11× · PMID 37188266 · DOI 10.3389/fphar.2023.1152314
8. Lymphatic Vessel Regression and Its Therapeutic Applications: Learning From Principles of Blood Vessel Regression.
   Masood F, Bhattaram R, Rosenblatt MI, Kazlauskas A, et al · · 2022 · cited 11× · PMID 35392370 · DOI 10.3389/fphys.2022.846936