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

Secondary Lymphedema Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03658967
Study type Interventional
Source Herantis Pharma Plc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 7, 2018
Completion date December 31, 2024
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