AzTrials
AzTrials

Lymphoma, T-Cell, CutaneousPhase 2PROMPTNCT03563040

Study of Photopheresis in the Treatment of Erythrodermic MF and SS

A Phase 2 study testing Methoxsalen and THERAKOS CELLEX Photopheresis System in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides/Sezary Syndrome, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Switzerland.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Methoxsalen and THERAKOS CELLEX Photopheresis System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2020to 1 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Erythrodermic mycosis fungoides or Sézary Syndrome (T4, N0-3, M0, B0-2) (for staging see table 1)
  • World Health Organization (WHO) performance status (PS) 0-2
  • Any prior treatment
  • With the exception of topical corticosteroids, skin care, itch and pain relieves all prior therapies for MF/SS have to be stopped/completed before registration.
  • No specific wash out period prior to registration is defined
  • Age ≥ 18, no upper limit
Show all 25Show fewer
  • Measurable disease
  • Adequate bone marrow function at time of registration :
  • Hemoglobin > 9.0 g/dL (> 5.6 mmol/L);
  • White blood cell count > 1 x 109/L (> 1000/mm3) and < 25 x 109/L (< 25,000/mm3);
  • Platelet count > 20 x 109/L (> 20,000/mm3);
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) according to Modification of Diet in Renal Disease (MDRD) ≥ 50 mL/min
  • Serum albumin ≥ 2.8 g/dL.
  • Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the initiation of the first study treatment.
  • WOCBP should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 1 month after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomised partner
  • Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
  • Male patients with pregnant or non-pregnant WOCBP partner should use condom during the study treatment period and for at least 1 month after the last study treatment.
  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.
  • Before patient registration, written informed consent must be obtained according to international conference on harmonisation/Good clinical practice (ICH/GCP) and national/local regulations.

Who cannot join

  • History of congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe)
  • History of any of the following cardiovascular conditions within 6 months prior to registration:
  • Unstable angina.
  • Clinically significant cardiac arrhythmias.
  • Myocardial infarction.
  • Poorly controlled hypertension defined at baseline as blood pressure (BP) >150/100 mmHg despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
Show all 17Show fewer
  • Active cancer other than MF/SS. Exceptions:
  • Patients with actinic keratoses should not be excluded, treatment should be decided by the treating physician according to local standards of care and be documented in the case report forms (CRFs)
  • Patients with non-skin in situ tumors (e.g. mucosal of any site, breast,,…) should be adequately treated prior to study entry.
  • Need for any systemic cancer therapy other than ECP at the time of registration according to the treating physician's decision
  • History of idiosyncratic or hypersensitivity reaction to methoxsalen, psoralen compounds or any of the excipients
  • Aphakia
  • History of photosensitive disease like but not limited to porphyria, systemic lupus erythematosus, or albinism.
  • Any medical conditions that do not allow extracorporeal volume loss like but not limited to severe cardiac disease, severe anaemia, severe renal disorder
  • Previous splenectomy
  • Coagulation disorders
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • UniversitaetsSpital Zurich - Division of Dermatology

    Zurich

Other trials in Switzerland

About this study

Official title: A Prospective, Multicenter, Single-Arm Cohort Study of Photopheresis in the Treatment of Erythrodermic MF and SS

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.

Read more

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.

Being tested
Methoxsalen, THERAKOS CELLEX Photopheresis System
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethoxsalenDrug

    Also called Uvadex

    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)

  • THERAKOS CELLEX Photopheresis SystemDevice

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

Study groups in NCT03563040
Study groupRoleWhat they receive
Methoxsalen with the THERAKOS CELLEX Photopheresis SystemExperimentalTreatment 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.
Receives: Drug: Methoxsalen; Device: THERAKOS CELLEX Photopheresis System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From treatment start up to 9 months for each patient

Secondary outcomes (10)

  1. Progression Free Survival, according to EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria

    From treatment start to progression

    Measured: From the first patient treatment start till 9 months as of LPI

  2. 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

    Measured: From the first patient treatment start till 9 months as of LPI

  3. Number of treatment cycles required to obtain remission

    Number of treatment cycles (including the add-on therapies) received by patients to obtain remission

    Measured: From the first patient treatment start till 9 months as of LPI

  4. Time to response (CR/PR)

    From treatment start to progression

    Measured: From the first patient treatment start till 9 months as of LPI

  5. Duration of response

    From response to progression

    Measured: From the first patient treatment start till 9 months as of LPI

  6. 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.

    Measured: From the first patient treatment start till 9 months as of LPI

  7. 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)

    Measured: From the first patient treatment start till 9 months as of LPI

  8. Occurrence of adverse events

    The study uses the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.

    Measured: From the first patient treatment start till 9 months as of LPI

  9. Overall survival (OS)

    Registration till the date of death from any cause

    Measured: From the first patient treatment start till 3 years as of LPI

  10. 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

    Measured: From the first patient treatment start till 9 months as of LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start1 Dec 2020 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Why it stopped: Lack of feasibility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563040
Sponsor's protocol ID
EORTC-1636-CLTF
Other IDs
2018-001685-42, 2018
Acronym
PROMPT
Status last verified
Aug 2021
First submitted
25 May 2018
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methoxsalen and THERAKOS CELLEX Photopheresis System in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides/Sezary Syndrome, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of treatment (photopheresis) (time frame: From treatment start up to 9 months for each patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in