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Secondary LymphedemaPhase 2AdeLENCT03658967

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

A Phase 2 study testing Lymfactin® (1x10E11 vp) in people with Secondary Lymphedema, run by Herantis Pharma Plc. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Secondary Lymphedema
What is being tested?
Lymfactin® (1x10E11 vp)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
5 sitesin 2 countries
Study dates
7 Jun 2018to 23 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)
  • Serum creatinine ≤ 1,5 x ULN or creatinine clearance ≥ 50 ml/min
  • Absolute neutrophil count (ANC) ≥ 1,5 E9/l
  • Platelet count ≥ 100 E9/l
  • Hemoglobin ≥ 100 g/l
  • Willingness to comply with scheduled visits, laboratory assessments, and other study-related procedures due to the regulatory requirements related to gene based therapies.
  • Non-smoker or willing to stop smoking or use of nicotine-containing products for at least 4 weeks prior to the study entry.
  • Negative urine pregnancy test (only patients with childbearing potential) at screening and use of adequate contraceptive measures from screening until six months after the study treatment administration:
  • A patient with childbearing potential should be using a reliable contraception method: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone releasing system (IUS), bilateral tubal occlusion, vasectomised partner or sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.
  • A male patient is not allowed to donate sperm.
  • A patient with no current heterosexual relationship may be included according to the judgement of the Investigator.
  • For patient in postmenopausal state neither contraception nor a pregnancy test is required. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy.
  • For permanently sterile patient neither contraception nor a pregnancy test is required. A permanently sterile is defined by history of hysterectomy, bilateral salpingectomy or bilateral oophorectomy.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Finland3 sites

  • Töölö Hospital, Department of Plastic Surgery

    Helsinki

  • Tampere University Hospital, Department of Plastic Surgery

    Tampere

  • Turku University Hospital, Department of Plastic Surgery

    Turku

Other trials in Finland

Sweden2 sites

  • Karolinska University Hospital, Department of Reconstructive Plastic Surgery

    Stockholm

  • Uppsala University Hospital, Department of Plastic Surgery

    Uppsala

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Lymfactin® (1x10E11 vp), Placebo
Keywords
Lymphedema, Breast cancer, Adenoviral vector, VEGF-C
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lymfactin® (1x10E11 vp)Drug

    Also called LX-1101, AdAptVEGF-C adenoviral vector

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

  • PlaceboDrug

    Also called 0.9% Physiological saline

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

Study groups in NCT03658967
Study groupRoleWhat they receive
Lymfactin® (1x10E11 vp)Active comparatorLymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.
Receives: Drug: Lymfactin® (1x10E11 vp)
Placebo (0.9% physiological saline)Placebo comparatorPlacebo will be administered as a single dose via perinodal injection in a volume of 2 mL.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of the volume of the arms

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

    Measured: 24 Months

  2. 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.

    Measured: 24 Months

  3. 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.

    Measured: 24 Months

Secondary outcomes (6)

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

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

    Measured: 24 Months

  2. CT scan of chest and abdomen

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

    Measured: 60 Months

  3. Lymfactin genome copy number in blood

    Changes in Lymfactin genome copy number in blood.

    Measured: 30 Days

  4. Lymfactin genome copy number in wound secretion

    Changes in Lymfactin genome copy number in wound secretion.

    Measured: 7 Days

  5. Formation of anti-Lymfactin antibodies

    Changes in anti-Lymfactin antibody titer in blood.

    Measured: 12 Months

  6. Systemic concentration of vascular endothelial growth factor C (VEGF-C)

    Changes in the VEGF-C concentration in blood.

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start7 Jun 2018
  3. Primary completion16 Dec 2019
  4. Study completion23 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, placebo-controlled, randomized
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658967
Sponsor's protocol ID
HP-LY-CL-2063
Other IDs
2017-004443-20, 2017
Acronym
AdeLE
Status last verified
Jun 2025
First submitted
6 Jul 2018
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lymfactin® (1x10E11 vp) in people with Secondary Lymphedema, run by Herantis Pharma Plc. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the volume of the arms (time frame: 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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