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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT02994771
• Date of registration: 10/11/2016
• Prospective Registration: No
• Primary sponsor: Herantis Pharma Plc.
• Public title: A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 15
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02994771
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Finland

Contacts

• Name: Anne Saarikko, MD, PhD
• Affiliation: HUCH

Key inclusion & exclusion criteria

Inclusion criteria:

1. Female patients with secondary lymphedema associated with the treatment of breast
cancer.

2. Patient who understands and voluntarily signs informed consent prior to any screening
procedure.

3. 18 - 70 years of age.

4. BMI between 18 and 32 inclusive.

5. Female patients with secondary lymphedema in the arm associated with breast cancer
who:

1. 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.

2. Require garment use as a compression treatment for the lymphedema in the affected
arm.

3. Have the volume of the affected arm at least 10% greater than the unaffected arm
following 7 days after removal of the compression garments.

4. Have the presence of pitting edema in the affected arm without compression
garments.

6. 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.

7. Patient with the following laboratory values:

1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times
the institutional upper limit of normal (ULN)

2. Bilirubin = 1.5 mg/dL

3. PT and PTT = 1.5 times the ULN

4. Serum creatinine = 2 mg/dL

5. Absolute neutrophil count (ANC) = 1,500 cells/mm³

6. Platelet count = 100,000/mm³

7. Hemoglobin = 10 g/dL

8. Willingness to comply with scheduled visits, laboratory assessments, and other
study-related procedures due to the regulatory requirements related to gene based
therapies.

9. Non-smoker or willing to stop smoking or using nicotine-containing products for at
least 4 weeks prior to entry to study.

10. 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:

1. 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).

2. A patient with no current heterosexual relationship may be included according to
the judgement of the Investigator.

3. If the patient is surgically sterile or whose menopause occurred 2 years
previously at the minimum, no contraception is required nor pregnancy test.

Exclusion criteria:

1. 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.

2. 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).

3. A patient known to be pregnant, lactating or having a positive or indeterminate
pregnancy test.

4. Treatment with COX-2 inhibitors should be interrupted from one week prior until 2
weeks post surgery and treatment with Lymfactin®.

5. Previous treatment with, or participation in, trial of a gene therapy product.

6. Current participation or participation in the preceding two months, in any clinical
study apart from a noninterventional study.

7. Current treatment with immunosuppressive drugs.

8. Current or history of drug, including nicotinecontaining products, or alcohol abuse.

9. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related
illness.

10. Allergy to any ingredients of the Lymfactin® solution for injection (glycerol,
N-2-hydroxyethylpiperazine-N´-2-ethanesulfonic acid (HEPES), sodium hydroxide).

11. 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.

12. Doubtful availability, in the opinion of the Investigator, to complete the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Secondary Lymphedema

Intervention(s)

Drug: Lymfactin® [1 x 10E11 vp]

Drug: Lymfactin® [1 x 10E10 vp]

Primary Outcome(s)

CT scan of chest and abdomen [Time Frame: baseline, yearly up to 5 years]

Biodistribution of Lymfactin in blood [Time Frame: 90 days]

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]

Formation of anti-Lymfactin antibodies [Time Frame: 6 months]

Secondary Outcome(s)

Measurement of the lymphatic flow of the affected arm by quantitative lymphoscintigraphy (99Tc-nanocolloid clearance rate with calculation of transport index) [Time Frame: baseline, 12, 24 and 36 months]

Measurement of the volume of the arms [Time Frame: baseline, 6, 12, 24 and 36 months]

Questionnaire according to the Lymphedema Quality of Life Inventory (LQOLI) [Time Frame: baseline, 6, 12, 24 and 36 months]

Secondary ID(s)

CL12001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors