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Secondary LymphedemaPhase 1NCT02994771

A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema

A Phase 1 study testing Lymfactin® [1 x 10E10 vp] and Lymfactin® [1 x 10E11 vp] in people with Secondary Lymphedema, run by Herantis Pharma Plc. at 3 sites in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer. Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Secondary Lymphedema
What is being tested?
Lymfactin® [1 x 10E10 vp] and Lymfactin® [1 x 10E11 vp]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesFinland
Study dates
Jun 2016to 5 Apr 2022
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with secondary lymphedema associated with the treatment of breast cancer.
  • Patient who understands and voluntarily signs informed consent prior to any screening procedure.
  • 18 - 70 years of age.
  • BMI between 18 and 32 inclusive.
  • Female patients with secondary lymphedema in the arm associated with breast cancer who:
  • Have undergone sentinel lymph node biopsies and/or lymph node resection in the axilla on the affected side of their breast cancer with initial N1 staging and lymph node metastasis in ≤ three lymph nodes.
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  • Require garment use as a compression treatment for the lymphedema in the affected arm.
  • Have the volume of the affected arm at least 10% greater than the unaffected arm following 7 days after removal of the compression garments.
  • Have the presence of pitting edema in the affected arm without compression garments.
  • No evidence of recurrent or active breast cancer at least 2 years and no more than 5 years after breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine and/or aromatase inhibitor treatment). PET CT scan of the chest and the abdomen within 45 days of treatment with Lymfactin® without signs of active breast cancer or any other malignancy.
  • Patient with the following laboratory values:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the institutional upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 mg/dL
  • PT and PTT ≤ 1.5 times the ULN
  • Serum creatinine ≤ 2 mg/dL
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • 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 using nicotine-containing products for at least 4 weeks prior to entry to study.
  • Negative urine pregnancy test (only patients with childbearing potential) at screening and use of adequate contraceptive measures from screening until 6 months after the study treatment administration:
  • A patient with childbearing potential should be using a reliable contraception method: intrauterine device (hormonal or non-hormonal); oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy).
  • A patient with no current heterosexual relationship may be included according to the judgement of the Investigator.
  • If the patient is surgically sterile or whose menopause occurred 2 years previously at the minimum, no contraception is required nor pregnancy test.

Who cannot join

  • A patient who had an N2/N3 or a T4 stage breast cancer or an inflammatory breast cancer at the time of the original diagnosis.
  • A patient with evidence (clinical, laboratory, or imaging) or history of a neoplasm other than breast cancer (except basal cell carcinoma or cervical in situ carcinoma).
  • A patient known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
  • Treatment with COX-2 inhibitors should be interrupted from one week prior until 2 weeks post surgery and treatment with Lymfactin®.
  • Previous treatment with, or participation in, trial of a gene therapy product.
  • Current participation or participation in the preceding two months, in any clinical study apart from a noninterventional study.
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  • Current treatment with immunosuppressive drugs.
  • Current or history of drug, including nicotinecontaining products, or alcohol abuse.
  • Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
  • Allergy to any ingredients of the Lymfactin® solution for injection (glycerol, N-2-hydroxyethylpiperazine-N´-2-ethanesulfonic acid (HEPES), sodium hydroxide).
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, that would affect the patient's ability to follow study-related procedures, or that may interfere with the interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
  • Doubtful availability, in the opinion of the Investigator, to complete the study.

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

  • Toeoeloe 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

About this study

Official title: A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema

Indicated for the Treatment of Secondary Lymphedema Associated with the Treatment of Breast Cancer.

Primary objective is to evaluate the safety and tolerability of a single dose of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer.

Read the detailed description

This is an open label, multi-center, uncontrolled first in human trial that uses a standard 3 + 3 dose escalation scheme. Lymfactin® will be administered as a single dose by ex vivo perinodal injection into the fat pad of a flap of tissue containing lymph nodes from the abdominal wall. This flap of tissue will then be surgically implanted into the axillary region of the affected arm. This treatment with Lymfactin® may be performed in conjunction with or without breast reconstruction surgery.

Up to two dose cohorts are planned to be included. Each dose of Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL:

  • Cohort 1: Lymfactin® [1 x 10E10 vp]
  • Cohort 2: Lymfactin® [1 x 10E11 vp]

Should the dose escalation go up to Cohort 2 with initiation of a subsequent Extension Cohort a total of 15 - 21 patients may be treated in this study.

Being tested
Lymfactin® [1 x 10E10 vp], Lymfactin® [1 x 10E11 vp]
Keywords
Lymphedema, Breast cancer
Medical subject headings
Breast Cancer Lymphedema

What participants receive

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

  • Lymfactin® [1 x 10E10 vp]Drug

    Also called LX-1101, AdAptVEGF-C Adenoviral Vector

    Lymfactin® [1 x 10E10 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.

  • Lymfactin® [1 x 10E11 vp]Drug

    Also called LX-1101, AdAptVEGF-C Adenoviral Vector

    Lymfactin® [1 x 10E11 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.

Study groups in NCT02994771
Study groupRoleWhat they receive
Lymfactin® [1 x 10E10 vp]Active comparatorLymfactin® [1 x 10E10 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
Receives: Drug: Lymfactin® [1 x 10E10 vp]
Lymfactin® [1 x 10E11 vp]Active comparatorLymfactin® [1 x 10E11 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
Receives: Drug: Lymfactin® [1 x 10E11 vp]

What is being measured

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

  1. Safety as measured by number of patients with treatment related adverse events and serious adverse events as assessed by CTCAE v4.0

    Adverse events and serious adverse events assessed by CTCAE v4.0 to evaluate the safety profile after administration of Lymfactin

    Measured: baseline to 1 year, yearly up to 5 years

  2. CT scan of chest and abdomen

    Changes in the CT scan of chest and abdomen in order to detect malignancies

    Measured: baseline, yearly up to 5 years

  3. Biodistribution of Lymfactin in blood

    Changes in Lymfactin genome copy number in blood

    Measured: 90 days

  4. Formation of anti-Lymfactin antibodies

    Changes in the anti-Lymfactin antibody titer in blood

    Measured: 6 months

Secondary outcomes (3)

  1. Measurement of the volume of the arms

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

    Measured: baseline, 6, 12, 24 and 36 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: baseline, 12, 24 and 36 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 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 each dimension. Each dimension 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 3 means "significant impact" on the quality of life of the patient, the smaller score thus being the better.

    Measured: baseline, 6, 12, 24 and 36 months

Timeline

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

  1. First posted16 Dec 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion3 Feb 2019
  4. Study completion5 Apr 2022

Why it stopped: Lack of efficacy

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994771
Sponsor's protocol ID
CL12001
Status last verified
Apr 2023
First submitted
10 Nov 2016
Last updated
24 Apr 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Pajula S, Saarikko A, Suominen S, Kaartinen I, Kiiski J, Suominen E, Viitanen T, Maki M, Seppanen M, Lahdenpera O, Alitalo K, Hartiala P. Lymfactin(R) gene therapy with vascularized lymph node transfer reduces compression-free swelling and enhances quality of life in breast cancer-related lymphedema: Final Phase I trial results. J Plast Reconstr Aesthet Surg. 2025 Dec;111:312-321. doi: 10.1016/j.bjps.2025.10.013. Epub 2025 Oct 16.

    PubMed 41173769

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lymfactin® [1 x 10E10 vp] and Lymfactin® [1 x 10E11 vp] in people with Secondary Lymphedema, run by Herantis Pharma Plc. at 3 sites in Finland.

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 24 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

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?

Safety as measured by number of patients with treatment related adverse events and serious adverse events as assessed by CTCAE v4.0 (time frame: baseline to 1 year, yearly up to 5 years). The study lists 4 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 NCT02994771, which also lists 1 linked publication.

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 24 Apr 2023.

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