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

NCT03658967 | Completed Phase 2 DMC

• 2 other identifiers: HP-LY-CL-20632017-004443-20
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Secondary Lymphedema

Keywords

Lymphedema; Breast cancer; Adenoviral vector; VEGF-C

Outcome Measures

Primary Outcomes (3)

• Measurement of the volume of the arms

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

  24 Months

• Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index).

  Assessment of the changes in the lymphatic flow.

  24 Months

• Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI)

  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.

  24 Months

Secondary Outcomes (6)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  24 Months

• CT scan of chest and abdomen

  60 Months

• Lymfactin genome copy number in blood

  30 Days

• Lymfactin genome copy number in wound secretion

  7 Days

• Formation of anti-Lymfactin antibodies

  12 Months

Other Outcomes (2)

• Optional evaluation of the anatomy and functionality of lymphatic vessels by MRI lymphangiography

  24 Months

• Percentage Water Content (PWC) measurement of water content and edema

  24 months

Study Arms (2)

Lymfactin® (1x10E11 vp)

ACTIVE COMPARATOR

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

Drug: Lymfactin® (1x10E11 vp)

Placebo (0.9% physiological saline)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lymfactin® (1x10E11 vp) DRUG

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

Also known as: LX-1101, AdAptVEGF-C adenoviral vector

Lymfactin® (1x10E11 vp)

Placebo DRUG

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

Also known as: 0.9% Physiological saline

Placebo (0.9% physiological saline)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients with secondary lymphedema associated with the treatment of breast cancer and
• Has undergone sentinel lymph node biopsies and/or lymph node resection in the axilla on the affected side of their breast cancer with initial N1-N2a staging and lymph node metastasis in ≤ 9 axillary lymph nodes.
• Requires garment use as a compression treatment for the lymphedema in the affected arm.
• Has the volume of the affected arm at least 10% greater than the unaffected arm following 7 days without compression garment.
• Has the presence of pitting edema in the affected arm without compression garment.
• Has had lymphedema for less than 5 years.
• No evidence of recurrent or active breast cancer for at least 2 years after the breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine treatment).
• Patient understands and voluntarily signs the written informed consent prior to any screening procedure.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Body Mass Index (BMI) between 18 and 32 inclusive.
• Positron Emission Tomography-Computed Tomography (PET CT) scan of the chest and the abdomen within 45 days before the study treatment without signs of active breast cancer or any other malignancy.
• Adequate hematologic and end-organ function.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limit of normal (ULN)
• Bilirubin ≤ 1.5 x ULN (except in patients with previously documented Gilbert's syndrome, in which case total bilirubin ≤ 3 x ULN)
• International Normalized ratio (INR) and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN (for patients requiring therapeutic anticoagulation therapy, a stable INR ≤ 2,5)

You may not qualify if:

• Diagnosed for T4 and/or N2b/N3 stage breast cancer at the time of the original diagnosis.
• Evidence (clinical, laboratory or imaging) or history of a neoplasm other than breast cancer (except basal cell carcinoma or cervical in situ carcinoma).
• Diagnosed for metastatic breast cancer.
• Pregnancy, lactation or a positive or indeterminate pregnancy test.
• Current treatment with Cyclooxygenase-2 (COX-2) inhibitors should be interrupted from 2 weeks prior until 4 weeks post-treatment.
• Previous treatment with, or participation in a trial of a gene therapy product.
• Participation in a clinical trial, which has included interventions in the preceding 6 months or will involve future interventions. Participation in a non-interventional clinical trial, or in a non-interventional follow-up of any clinical trial, does not make the patient inappropriate for the entry into this study.
• Current treatment with immunosuppressive drugs.
• Current history of drug abuse, including nicotine-containing products, or alcohol abuse.
• Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
• History of hepatic dysfunction, cirrhosis, or hepatitis.
• Allergy to any ingredients of the Lymfactin® solution for injection.
• Other concurrent severe acute and/or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or study drug administration, that would, in the Investigator's judgement, affect the patient's ability to follow study-related procedures, or that may interfere with the interpretation of study results and would make the patient inappropriate for the entry into this study.
• Doubtful availability, in the opinion of the Investigator, to complete the study.

Sponsors & Collaborators

• Herantis Pharma Plc.: lead

Study Sites (5)

Töölö Hospital, Department of Plastic Surgery

Helsinki, Finland

Location

Tampere University Hospital, Department of Plastic Surgery

Tampere, Finland

Location

Turku University Hospital, Department of Plastic Surgery

Turku, Finland

Location

Karolinska University Hospital, Department of Reconstructive Plastic Surgery

Stockholm, Sweden

Location

Uppsala University Hospital, Department of Plastic Surgery

Uppsala, Sweden

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anne Saarikko, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Maria Mani, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, randomized

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: September 6, 2018
• Study Start: June 7, 2018
• Primary Completion: December 16, 2019
• Study Completion: October 23, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

FI (3); SE (2)