Mycosis FungoidesNCT05303480

Deep Phenotyping of Cutaneous T Cell Lymphoma, Type Mycosis Fungoides

A study testing Chlormethine in people with Mycosis Fungoides, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Mycosis Fungoides
What is being tested?: Chlormethine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteNetherlands
Study dates: 7 Dec 2021to 8 Dec 2022
Phase: Interventional
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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Healthy volunteers must meet all of the following inclusion criteria:

Signed informed consent prior to any study-mandated procedure;
Male or female subjects, 18 to 75 years of age, inclusive at screening; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigators;
Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2; during COVID-19 pandemic only ≥ 18.0 and ≤ 33.0 kg/m2;
No clinically significant skin disease as judged by the investigator;
No history of hypertrophic scarring or keloid;
Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 4 hours before every study visit;
Subject is willing and able to washout and withhold any topical treatment (prescription and over the counter products) in the treatment area (if possible matched location to most common location of target lesions of the MF group, and otherwise 100cm2 on the lower back) for 2 weeks prior to Day 1;
Subject is willing to refrain from application of any topical product (e.g. ointments, crème or washing lotions) on the skin 24 hours prior to every study visit day;
Subject is willing and able to washout (topical and oral) antibiotic therapy for 14 days prior to Day 1;
Subject is willing to use effective contraception from screening until EOS if subject is male or women of childbearing potential;
Subject has the ability to communicate well with the investigator in the Dutch language and is willing to comply with the study requirements.

Eligible MF patients must meet all of the following inclusion criteria at screening:

Signed informed consent prior to any study-mandated procedure;
Male or female subjects, 18 to 75 years of age, inclusive at screening; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigators
Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2; during COVID-19 pandemic only ≥ 18.0 and ≤ 33.0 kg/m2;
At least one patch and/or plaque lesion present, with at least one dimension with a diameter of ≥ 6cm;
Confirmed MF-diagnosis (stage 1a/1b) by histology (or clinico-histopathological correlation) within the last 10 years;
Willing and able to washout any topical treatment for MF (at least 2 weeks) and any systemic treatment for MF (at least 4 weeks) prior to Day 1, resulting in a washout of 8 weeks for topical treatment and 10 weeks for disease-related systemic treatment prior to the first dosing day (day 43);
No previous use of CL gel (Ledaga) in the past two years;
Subject is willing and able to washout (topical and oral) antibiotic therapy for 14 days prior to Day 1;
Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 6 hours before every study visit day and up to 2 hours after application of the treatment gel;
Subject is willing to use effective contraception during the study if subject is male or women of child bearing potential, for up to 90 days after the last dose of study treatment;
Male subjects must be willing to withhold from any sperm donation during the study and up to 90 days after the last dose of study treatment.

Eligible healthy volunteers must meet none of the following exclusion criteria at screening:

History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator;
The use of systemic antibiotic therapy for >2 months the past 12 months;
The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives.
Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening;
Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year;
Loss or donation of blood over 500mL within three months prior to screening;
History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 24 hours preceding each study visit;
Positive urine test for drugs or history of abuse at screening or pre-dose. Urine drug test may be repeated at the discretion of the investigator;
Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
Any other known factor, condition, or disease that might interfere with study conduct or interpretation. Eligible MF-patients must meet none of the abovementioned and following exclusion criteria at screening:
Have any current relevant skin infections/disease in the treatment area other than the observational disease (mycosis fungoides), inclusively, but not limited to atopic dermatitis, psoriasis vulgaris, dermatomycosis and other skin malignancies.
Having received treatments for MF or any other disease within the following intervals prior to the start of the study (The use of topical emollients is allowed during the study. For target lesions it is allowed up to 24h before every study visit day):
< 2 weeks for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs
<4 weeks for phototherapy, e.g. UVB, PUVA, PDT
<4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate
<6 weeks for peginterferon alfa-2a
<8 weeks for radiotherapy or surgery in the treatment area
<3 months for any systemic chemotherapeutical treatment
Known hypersensitivity to chlormethine gel or its excipients.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Centre for Human Drug Research
Leiden, 2333 CL

Other trials in Netherlands

About this study

Official title: An Exploratory, Single-centre, Two-part Study to Describe Mycosis Fungoides Characteristics and Explore Novel Biomarkers With a Multi- Modal Patient Profiling Approach by Comparing MF Patients to Healthy Volunteers

Mycosis fungoides (MF) is an ultra-orphan disease of which the etiology remains unknown. MF is diagnosed by correlating clinical appearance with histopathological analysis of often multiple invasive skin punch biopsies. To move patient care and the development of novel treatments for MF forward, objective, sensitive and reliable tools that are preferably non-invasive are desired. Therefore, the objective of the current study is to phenotype the early stages of mycosis fungoides in detail and to assess the response of chlormethine (CL) gel monotherapy. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.

Read the detailed description

In recent years, knowledge about the wide spectrum of cutaneous T-cell lymphomas (CTCL) has broadened. Mycosis fungoides (MF) comprises about 50-70% of all primary cutaneous T-cell lymphomas (Willemze et al, 2019). Many CTCL are misdiagnosed due to clinical and histopathological similarity to other skin conditions (such as psoriasis vulgaris, atopic dermatitis and tinea corpora), low prevalence of disease and a lack of reliable tools for detection of these diseases, resulting in delayed diagnosis with years of discomfort and possibly a worse prognosis. Furthermore, standard treatment has never been proven curative, has many side effects and exacerbations are frequent. To date, the etiology of mycosis fungoides remains unknown and little research has been conducted into the mechanisms underlying its development and its response to treatment.

Mycosis fungoides lesions change over time and differ between patients, consisting of three morphologically different stages: patches (erythematosquamous maculae), plaques (erythematosquamous, elevated and occasionally infiltrated lesions) and tumors (with or without ulceration). Only a relatively small group of patients advances to tumor stage MF during their lifetime. Mycosis fungoides is diagnosed by correlating clinical appearance with histopathological analysis of an invasive skin punch biopsy. Additionally, often multiple biopsies are required after diagnosis, e.g. when a lesion is clinically advancing to a different stage or if lesion origin is ambiguous. Currently no other biomarkers besides skin punch biopsies markers are available for the diagnosis of MF, the evaluation of a MF lesion over time, and the monitoring of a potential treatment effect. To advance MF patient care and the development of novel treatments for MF objective, sensitive and reliable (preferably non-invasive) tools are desired.

Therefore, the objective of the current study is to evaluate disease-related characteristics and biomarkers, the intra- and inter-patient variability of biomarkers, to evaluate biomarkers for disease-monitoring following CL gel treatment and to investigate and monitor skin-related adverse events that might develop after CL gel application in MF patients. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.

For this purpose, a multi-modal patient profiling approach with in-depth characterization of cutaneous T-cell lymphomas will be performed. A clinical study will be conducted investigating the biology of the disease compared to healthy volunteers (part A) and patients' response to intervention (part B). The former to characterize objectively measured disease characteristics and mechanisms underlying its development, the latter to monitor the biomarker response associated to a MF-CTCL treatment, in this case CL gel. The study focusses on cellular, molecular, biophysical, imaging and microbiome analyses in comparison to healthy controls and between lesional and non-lesional skin of MF patients.

Conditions: Mycosis Fungoides
Being tested: Chlormethine
Keywords: Mycosis Fungoides, Cutaneous T Cell Lymphoma, Biomarker, Chlormethine, Ledaga
Medical subject headings: Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous

What participants receive

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

ChlormethineDrug
Also called Ledaga, Valchlor
Chlormethine gel 0.016%

Study groups in NCT05303480
Study group	Role	What they receive
Chlormethine gel	Active comparator	Chlormethine gel 0.016% in 60mg tube, topical home administration from day 0 to day 155. Receives: Drug: Chlormethine
Healthy volunteers	No intervention	Healthy volunteer cohort (observational)

What is being measured

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

Composite Assessment of Index Lesions Disease Severity Score (CAILS)
CAILS is a composite score to quantify lesion severity and consists of scoring erythema, hypo-/hyperpigmentation, plaque elevation, desquamation and lesion size. The CAILS score of a single lesion ranges from 0 (unaffected) to 50 (severely affected).
Measured: from day -42 to day 155
Modified Severity Weighted Assessment Tool (mSWAT)
mSWAT combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 (unaffected) to 400 (severely affected).
Measured: from day -42 to day 155
Objective Response Rate (ORR)
The Objective Response Rate (ORR) measures the lesional response as the change from baseline for the CAILS and mSWAT score. The ORR is the number of patients with complete response (100% clearance) + the number of patients with partial response (50%-99%) divided by the total number of patients.
Measured: from day 43 to day 155
SKINDEX-29: Quality of life (QoL)
The Skindex-29 is a valid 29-item self-report measure that evaluates health-related QoL for patients with dermatological diseases. The score is subdivided in a domain for symptoms, emotions and fuctioning; domain scores range from 0 (no impact) to 100 (severely impacted). Total Skindex-29 score is calculated as a mean of the three domains, ranging from 0 (no impact on QoL) to 100 (QoL severely impacted).
Measured: from day 0 to day 155
Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM consists of 14 questions and explores the subject satisfaction regarding the effectiveness, the side effects, convenience and global satisfaction of the investigational drug. The TSQM score ranges from 0 (lowest satisfaction) to 100 (highest satisfaction).
Measured: from day 43 to day 155
Patient reported outcomes
Patients will be asked to report on their condition through a Numerical Rating Scale (0 (better)- 100 (worse)) for itch, pain and sleeplessness.
Measured: from day 0 to day 155
Erythema measurement of the skin
Redness of the skin will be determined using a colorimeter
Measured: from day 0 to day 155
3D Multispectral imaging
The redness and superficial morphology of (non-)lesional skin sites will be determined using a 3D multispectral imaging system.
Measured: from day 0 to day 155
Laser Speckle Contrast Imaging (LSCI)
The cutaneous microcirculation of (non-)lesional skin sites will be monitored over a 40 second timespan with a laser speckle contrast imager.
Measured: from day 0 to day 155
Thermography
Body surface temperature of (non-)lesional skin will be determined using a thermal imaging infrared camera.
Measured: from day 0 to day 155
Optical Coherence Tomography (OCT)
OCT is a non-invasive assessment which visualizes skin morphology in vivo to a depth of 2 mm with the use of infrared light.
Measured: from day 0 to day 155
Skin barrier function by Trans-Epidermal Water Loss (TEWL)
The barrier status by trans epidermal water loss of (non-)lesional skin will be determined using TEWL. (g/m2/h)
Measured: from day 0 to day 155
Cutaneous microbiome
The cutaneous microbiome of (non-)lesional skin is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.
Measured: from day 0 to day 155
Faecal microbiome
The bacterial composition of stool samples pre- and post-treatment will be determined using next-generation sequencing.
Measured: from day 43 to day 155
Skin surface biomarkers
Superficial protein biomarkers of (non-)lesional skin will be assessed by a non-invasive transdermal patch by FibroTx. The presence of protein biomarkers will be determined using ELISA.
The following biomarkers will be assessed (ng/ul): IL-8, CXCL-2, IL-1A, IL-1RA, CCL-17 and CCL-27 and VEGF.
Measured: from day 0 to day 155
Lipidomics of the stratum corneum by liquid chromatography mass spectroscopy
Tape stripping will be performed on (non-)lesional skin and lipids are subsequently extracted from the tape and analyzed using Liquid Chromatography-Mass Spectrometry (ng/cm2).
Measured: from day 0 to day 155
Patient genotyping
A whole blood sample will be used to scan for common mutations in genes implicated in mycosis fungoides using next-generation sequencing.
Measured: day 43
Blister immune cell subsets
Blisters will be induced on the (non-)lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Measured: day 43
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Blisters will be induced on the (non-)lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).
Measured: day 43
Immunohistochemistry and Imaging Mass Cytometry/VECTRA of biopsies
Biopsies will be sectioned and stained for the determination of the cutaneous homeostasis and tumor micro-environment by visualising infiltration of cellular immune subsets (e.g. presence of CD4 and CD8).
Measured: from day 43 to day 155
Circulating protein biomarkers by PCR amplification
Blood will be drawn using a venipuncture during visits and analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8).
Measured: from day 0 to day 155
Cells/ml; Circulating immune cell subsets
Blood will be drawn using a venipuncture during visits and analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Measured: from day 0 to day 155
Itch Tracking by Derma Track
Subjects are requested to wear a smartwatch during the night to register total duration of scratch movements.
Measured: from day 0 to day 155
User experience and subjective burden questionnaire
Measures the user experience and subjective burden of the different imaging modalities used in this study. Scores ranging from 0 (no burden) to 100 (severe burden).
Measured: from day 43 to day 155
Blister immune cell subsets during dermatitis reactions
Blisters will be induced on the lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Measured: from day 43 to day 155
Change from baseline in blister immune cell subsets after 16 weeks of treatment
Blisters will be induced on the lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Measured: day 43 and day 155
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Blisters will be induced on the lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).
Measured: from day 43 to day 155
Change from baseline in blister protein biomarkers, by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Blisters will be induced on the lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).
Measured: day 43 and day 155

Timeline

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

7 Dec 20218 Dec 2022

First posted31 Mar 2022
Study start7 Dec 2021
Primary completion8 Dec 2022
Study completion8 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: This is an observational and interventional study in 20 Mycosis Fungoides patients and 10 healthy volunteers (observational only).
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05303480
Sponsor's protocol ID: CHDR1947
Other IDs: 2021-001576-41, NL77292.056.21
Status last verified: Mar 2022
First submitted: 7 Dec 2021
Last updated: 25 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8

All Mycosis Fungoides trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, Single-centre, Two-part Study to Describe Mycosis Fungoides Characteristics and Explore Novel Biomarkers With a Multi- Modal Patient Profiling Approach by Comparing MF Patients to Healthy Volunteers
ClinicalTrials.gov ID: NCT05303480
Acronym / sponsor ID: CHDR1947
Conditions: Mycosis Fungoides
Keywords: Mycosis Fungoides, Cutaneous T Cell Lymphoma, Biomarker, Chlormethine, Ledaga
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Centre for Human Drug Research, NetherlandsUniversity, hospital or other
Collaborators: RECORDATI GROUP
Study start: 7 Dec 2021 (actual)
Primary completion: 8 Dec 2022 (actual)
Study completion: 8 Dec 2022 (actual)
First posted: 31 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: This is an observational and interventional study in 20 Mycosis Fungoides patients and 10 healthy volunteers (observational only).

Arm	Type	Receives
Chlormethine gel	Active comparator	Drug: ChlormethineChlormethine gel 0.016% in 60mg tube, topical home administration from day 0 to day 155.
Healthy volunteers	No intervention	–Healthy volunteer cohort (observational)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChlormethineAlso: Ledaga, ValchlorChlormethine gel 0.016%	Drug	Chlormethine gel

Primary outcome

Composite Assessment of Index Lesions Disease Severity Score (CAILS)
Time frame: from day -42 to day 155
CAILS is a composite score to quantify lesion severity and consists of scoring erythema, hypo-/hyperpigmentation, plaque elevation, desquamation and lesion size. The CAILS score of a single lesion ranges from 0 (unaffected) to 50 (severely affected).
Modified Severity Weighted Assessment Tool (mSWAT)
Time frame: from day -42 to day 155
mSWAT combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 (unaffected) to 400 (severely affected).
Objective Response Rate (ORR)
Time frame: from day 43 to day 155
The Objective Response Rate (ORR) measures the lesional response as the change from baseline for the CAILS and mSWAT score. The ORR is the number of patients with complete response (100% clearance) + the number of patients with partial response (50%-99%) divided by the total number of patients.
SKINDEX-29: Quality of life (QoL)
Time frame: from day 0 to day 155
The Skindex-29 is a valid 29-item self-report measure that evaluates health-related QoL for patients with dermatological diseases. The score is subdivided in a domain for symptoms, emotions and fuctioning; domain scores range from 0 (no impact) to 100 (severely impacted). Total Skindex-29 score is calculated as a mean of the three domains, ranging from 0 (no impact on QoL) to 100 (QoL severely impacted).
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: from day 43 to day 155
TSQM consists of 14 questions and explores the subject satisfaction regarding the effectiveness, the side effects, convenience and global satisfaction of the investigational drug. The TSQM score ranges from 0 (lowest satisfaction) to 100 (highest satisfaction).
Patient reported outcomes
Time frame: from day 0 to day 155
Patients will be asked to report on their condition through a Numerical Rating Scale (0 (better)- 100 (worse)) for itch, pain and sleeplessness.
Erythema measurement of the skin
Time frame: from day 0 to day 155
Redness of the skin will be determined using a colorimeter
3D Multispectral imaging
Time frame: from day 0 to day 155
The redness and superficial morphology of (non-)lesional skin sites will be determined using a 3D multispectral imaging system.
Laser Speckle Contrast Imaging (LSCI)
Time frame: from day 0 to day 155
The cutaneous microcirculation of (non-)lesional skin sites will be monitored over a 40 second timespan with a laser speckle contrast imager.
Thermography
Time frame: from day 0 to day 155
Body surface temperature of (non-)lesional skin will be determined using a thermal imaging infrared camera.
Optical Coherence Tomography (OCT)
Time frame: from day 0 to day 155
OCT is a non-invasive assessment which visualizes skin morphology in vivo to a depth of 2 mm with the use of infrared light.
Skin barrier function by Trans-Epidermal Water Loss (TEWL)
Time frame: from day 0 to day 155
The barrier status by trans epidermal water loss of (non-)lesional skin will be determined using TEWL. (g/m2/h)
Cutaneous microbiome
Time frame: from day 0 to day 155
The cutaneous microbiome of (non-)lesional skin is collected by swabbing. The abundance of bacteria is thereafter determined using next-generation sequencing.
Faecal microbiome
Time frame: from day 43 to day 155
The bacterial composition of stool samples pre- and post-treatment will be determined using next-generation sequencing.
Skin surface biomarkers
Time frame: from day 0 to day 155
Superficial protein biomarkers of (non-)lesional skin will be assessed by a non-invasive transdermal patch by FibroTx. The presence of protein biomarkers will be determined using ELISA. The following biomarkers will be assessed (ng/ul): IL-8, CXCL-2, IL-1A, IL-1RA, CCL-17 and CCL-27 and VEGF.
Lipidomics of the stratum corneum by liquid chromatography mass spectroscopy
Time frame: from day 0 to day 155
Tape stripping will be performed on (non-)lesional skin and lipids are subsequently extracted from the tape and analyzed using Liquid Chromatography-Mass Spectrometry (ng/cm2).
Patient genotyping
Time frame: day 43
A whole blood sample will be used to scan for common mutations in genes implicated in mycosis fungoides using next-generation sequencing.
Blister immune cell subsets
Time frame: day 43
Blisters will be induced on the (non-)lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Time frame: day 43
Blisters will be induced on the (non-)lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).
Immunohistochemistry and Imaging Mass Cytometry/VECTRA of biopsies
Time frame: from day 43 to day 155
Biopsies will be sectioned and stained for the determination of the cutaneous homeostasis and tumor micro-environment by visualising infiltration of cellular immune subsets (e.g. presence of CD4 and CD8).
Circulating protein biomarkers by PCR amplification
Time frame: from day 0 to day 155
Blood will be drawn using a venipuncture during visits and analyzed for the presence of various chemokines and cytokines (e.g. CCL20, CCL17, CXCL8).
Cells/ml; Circulating immune cell subsets
Time frame: from day 0 to day 155
Blood will be drawn using a venipuncture during visits and analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Itch Tracking by Derma Track
Time frame: from day 0 to day 155
Subjects are requested to wear a smartwatch during the night to register total duration of scratch movements.
User experience and subjective burden questionnaire
Time frame: from day 43 to day 155
Measures the user experience and subjective burden of the different imaging modalities used in this study. Scores ranging from 0 (no burden) to 100 (severe burden).
Blister immune cell subsets during dermatitis reactions
Time frame: from day 43 to day 155
Blisters will be induced on the lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Change from baseline in blister immune cell subsets after 16 weeks of treatment
Time frame: day 43 and day 155
Blisters will be induced on the lesional skin and the blister exudate aspirated. Blister exudate will be analyzed for the presence of immune cells (e.g. CD4+ and CD8+ T-Cells) using flow cytometry.
Blister protein biomarkers by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Time frame: from day 43 to day 155
Blisters will be induced on the lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).
Change from baseline in blister protein biomarkers, by high-throughput, multiplex immunoassays of proteins by Proximity Estension Assay (PEA) technology
Time frame: day 43 and day 155
Blisters will be induced on the lesional skin and blister fluid aspirated. Blister fluid will be analyzed for the presence of various chemokines and cytokines using the Olink inflammation and immuno-oncology panel (96 proteins per panel, e.g. PD-L1, IL-4, IL-12, IL-13, ng/ml).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
Individual participant dataSharing planned: No

Related trials for Mycosis Fungoides

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Rissmann, Prof. Dr. principal investigator

Centre for Human Drug Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chlormethine in people with Mycosis Fungoides, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 25 Jan 2023. 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 Netherlands. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite Assessment of Index Lesions Disease Severity Score (CAILS) (time frame: from day -42 to day 155). The study lists 28 primary outcomes in all. 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 NCT05303480.

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 25 Jan 2023.