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Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02994771
Study type Interventional
Source Herantis Pharma Plc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 2016
Completion date February 2024

See also
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Completed NCT01748604 - Physical Therapies in the Decongestive Treatment of Lymphedema N/A