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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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)
Methoxsalen is used in conjunction with the THERAKOS CELLEX Photopheresis System.
UniversitaetsSpital Zurich - Division of Dermatology
Zurich, Switzerland
Success rate of treatment (photopheresis)
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
Time frame: From treatment start up to 9 months for each patient
Progression Free Survival, according to EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria
From treatment start to progression
Time frame: From the first patient treatment start till 9 months as of LPI
Best overall response rates, according to EORTC-ISCL-USCLC criteria
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
Time frame: From the first patient treatment start till 9 months as of LPI
Number of treatment cycles required to obtain remission
Number of treatment cycles (including the add-on therapies) received by patients to obtain remission
Time frame: From the first patient treatment start till 9 months as of LPI
Time to response (CR/PR)
From treatment start to progression
Time frame: From the first patient treatment start till 9 months as of LPI
Duration of response
From response to progression
Time frame: From the first patient treatment start till 9 months as of LPI
Frequency and type of of add-on therapies
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 frame: From the first patient treatment start till 9 months as of LPI
Quality of life measurements
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)
Time frame: From the first patient treatment start till 9 months as of LPI
Occurrence of adverse events
The study uses the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
Time frame: From the first patient treatment start till 9 months as of LPI
Overall survival (OS)
Registration till the date of death from any cause
Time frame: From the first patient treatment start till 3 years as of LPI
Time to initiation of add-on therapies
Time to initiation of add-on therapies will be measured from the date of treatment start to the date that add-on therapies initiated
Time frame: From the first patient treatment start till 9 months as of LPI
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