Study of Photopheresis in the Treatment of Erythrodermic MF and SS

Phase 2

Withdrawn

• Conditions: Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides/Sezary Syndrome
• Interventions: Drug: Methoxsalen; Device: THERAKOS CELLEX Photopheresis System

• Registration Number: NCT03563040
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-20
• Study Start: 2020-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08
• Primary Completion: 2022-09-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methoxsalen with the THERAKOS CELLEX Photopheresis System	THERAKOS CELLEX Photopheresis System	Treatment will be performed according to a predefined protocol based on the consensus guidelines in patients with MF/SS. Treatment should be administered for one year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol.
Methoxsalen with the THERAKOS CELLEX Photopheresis System	Methoxsalen	Treatment will be performed according to a predefined protocol based on the consensus guidelines in patients with MF/SS. Treatment should be administered for one year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol.

Primary Outcome Measures

Name	Time	Method
Success rate of treatment (photopheresis)	From treatment start up to 9 months for each patient	The primary endpoint is defined as successful use of photopheresis performed according to the study protocol based on the consensus guidelines.; At 9 months time point after the initiation of photopheresis, evaluation of each patient will be performed. A patient will be declared a success with respect to the primary endpoint if she/he fulfills: 1. Patient has received the full protocol treatment; 2. No progressive disease within the first 3 months after of the initiation of photopheresis.; 3. No need for add-on (combination) treatment within the first 3 months after the initiation of photopheresis according to investigators decision.; 4. Not experiencing any medical event (other than progressive disease) necessitating termination of photopheresis or interruption for more than 3 continuous months within the 6 months period

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival, according to EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria	From the first patient treatment start till 9 months as of LPI	From treatment start to progression
Best overall response rates, according to EORTC-ISCL-USCLC criteria	From the first patient treatment start till 9 months as of LPI	Overall response rate is defined as the proportion of patients with global response score equal to complete response (CR) or partial response (PR) according to EORTC-ISCL-USCLC criteria.; Global Response Score; CR - Complete disappearance of all clinical evidence of disease; Skin: CR, Nodes/Blood/Viscera: All categories have CR/Not Indicated; PR - Regression of measurable disease; Skin: CR, Nodes/Blood/Viscera: All categories do not have a CR/ Not Indicated and no category has a PD or Skin: PR, Nodes/Blood/Viscera: No category has a PD and if any category involved at baseline, at least one has a CR or PR
Quality of life measurements	From the first patient treatment start till 9 months as of LPI	Skin disease-specific Skindex-29 and the Functional Assessment of Cancer Therapy in General (FACT-G); SKINDEX-29: Symptoms scale ranging from: Very little, Mild, Moderate, Severe, Extreme; FACT G: 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much)
Number of treatment cycles required to obtain remission	From the first patient treatment start till 9 months as of LPI	Number of treatment cycles (including the add-on therapies) received by patients to obtain remission
Frequency and type of of add-on therapies	From the first patient treatment start till 9 months as of LPI	Frequency and type of add-on therapies received by patients. The add-on could consist any systemic or skin directed therapies that is considered to be active in or given with the intent to treat MF/SS.
Time to response (CR/PR)	From the first patient treatment start till 9 months as of LPI	From treatment start to progression
Duration of response	From the first patient treatment start till 9 months as of LPI	From response to progression
Time to initiation of add-on therapies	From the first patient treatment start till 9 months as of LPI	Time to initiation of add-on therapies will be measured from the date of treatment start to the date that add-on therapies initiated
Occurrence of adverse events	From the first patient treatment start till 9 months as of LPI	The study uses the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
Overall survival (OS)	From the first patient treatment start till 3 years as of LPI	Registration till the date of death from any cause

Trial Locations

Locations (1)

UniversitaetsSpital Zurich - Division of Dermatology; 🇨🇭 Zürich, Switzerland