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Study of Photopheresis in the Treatment of Erythrodermic MF and SS

NCT03563040 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-09-08

No results posted yet for this study

Summary

PROMPT: a study of photopheresis for the treatment of erythrodermic mycosis fungoides and Sézary syndrome

For this study, the investigators invite patients suffering from erythrodermic mycosis fungoides (MF) and Sézary syndrome (SS) whose skin symptoms have not responded to other types of treatment prescribed by their doctors (symptoms came back or got worse) as well as patients that never received any treatment.

Patients will be treated with photopheresis every two weeks for the first three months, thereafter once monthly. One treatment cycle consists of 2 day treatment in a row. After 6 months of treatment, treatment can be given every 5 to 8 weeks.

During the photopheresis procedure, the patient's blood is collected into a specialized machine (THERAKOS CELLEX) that separates the white blood cells from the other blood components. The other blood components are returned to the patient and white blood cells are then treated with the drug methoxsalen, which makes them sensitive to ultraviolet light. The treated white blood cells are exposed to ultraviolet A (UVA) irradiation inside the machine, and then returned to the patient.

As photopheresis has been used worldwide for more than 30 years, each hospital has developed their own guidelines (e.g. which patients, frequency, etc). Recently, experts in the field have developed a guidance which will now be tested in this study.

Conditions

  • Lymphoma, T-Cell, Cutaneous
  • Mycosis Fungoides/Sezary Syndrome

Interventions

DRUG

Methoxsalen

Methoxsalen is used in conjunction with the THERAKOS CELLEX Photopheresis System. During each photopheresis treatment with methoxsalen, the dosage of methoxsalen is calculated according to the treatment volume (which is displayed on the display panel of the instrument) using the formula: Treatment volume x 0.017 ml of methoxsalen (20 µg/mL) for each treatment For example: Treatment volume = 240 mL x 0.017 = 4.1 mL of methoxsalen (20 µg/mL)

DEVICE

THERAKOS CELLEX Photopheresis System

Methoxsalen is used in conjunction with the THERAKOS CELLEX Photopheresis System.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Robert Knobler · Medical University Vienna - General Hospital AKH, Vienna, Austria

  • Franz Trautinger · Karl Landsteiner University of Health Sciences, University Hospital of St. Poelten, St. Poelten, Austria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-09-01
Completion
2026-06-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563040 on ClinicalTrials.gov