Blood and Lymph Conditions

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Lymphatic Diseases

Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.

Placebo will be administered as a single dose via perinodal injection in a volume of 2 mL.

Lymfactin® (1x10E11 vp)

Placebo

Anne Saarikko, MD, PhD

Maria Mani, MD, PhD

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.

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.

Double-blind, placebo-controlled, randomized

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

Changes in anatomy and functionality of lymphatic vessels by newly developed MRI lymphangiography and comparison of the correlation of the method to the already established lymphoscintigraphy in the assessment of lymphedema.

Changes in PWC measurement of water content and edema in affected arm and comparison to the unaffected arm.

Changes in the volume of the affected arm and comparison to the unaffected arm.

Assessment of the changes in the lymphatic flow.

Assessment of changes in the quality of life using Lymphedema Quality of Life Inventory (LQOLI) in which the patients assess how their lymphedema is affecting the activities of daily living. LQOLI consists of three dimensions: Physical, psychosocial and practical, which are reported separately as the mean score of that part. Each part of the LQOLI is scored from 0 to 3, where score 0 means "no impact", 1 means "a little bit impact", 2 means "somewhat impact" and score 3 means "significant impact" on the quality of life of the patient, the smaller score thus being the better.

Adverse Events as assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin.

Changes in CT scans of chest and abdomen in order to detect malignancies.

Changes in Lymfactin genome copy number in blood.

Changes in Lymfactin genome copy number in wound secretion.

Changes in anti-Lymfactin antibody titer in blood.

Changes in the VEGF-C concentration in blood.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)	NCT03658967	Secondary Lymph...	Lymfactin® (1x1... Placebo	18 Years - 70 Years	Herantis Pharma Plc.
Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE)	NCT03658967	Secondary Lymph...	Lymfactin® (1x1... Placebo	18 Years - 70 Years	Herantis Pharma Plc.

Spots Global Cancer Trial Database for lymfactin® (1x10e11 vp)