NCT03658967

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

Phase 2, Double-Blind, Placebo-Controlled, Randomized Efficacy, Safety and Tolerability Study of Lymfactin in Combination With Surgical Lymph Node Transfer To Patients With Secondary Lymphedema Associated With the Treatment of Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase II, double-blind, placebo-controlled, multi-centre clinical study, in which 40 patients with breast cancer associated secondary lymphedema will be randomized 1:1 either to Lymfactin® (1 x 10E11 viral particles, vp) or placebo (0.9% physiological saline) group. The study product (Lymfactin® or placebo solution) will be administered as a single dose in a volume of two (2) mL, by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the patient's own abdominal wall or the groin area. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with the study product is performed in combination with a surgical lymph node transfer, in conjunction with or without breast reconstruction surgery. Patients will be followed-up for efficacy and safety according to a specified schedule up to 5 years post-treatment.

Conditions

• Secondary Lymphedema

Interventions

Type	Name	Description
DRUG	Lymfactin® (1x10E11 vp)	Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.
DRUG	Placebo	Placebo will be administered as a single dose via perinodal injection in a volume of 2 mL.

Timeline

• Start date: 2018-06-07
• Primary completion: 2019-12-16
• Completion: 2024-10-23
• First posted: 2018-09-06
• Last updated: 2025-07-09

Locations

5 sites across 2 countries: Finland, Sweden