An observational study in Mycosis Fungoides, sponsored by National and Kapodistrian University of Athens. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by National and Kapodistrian University of Athens · Observational
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Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, clinical data from the investigators' clinic confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. Based investigators' clinical and biological results , the investigators like to further investigate the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.
RATIONALE Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, the clinical data confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. In a study of 23 patients with stage IA-IIB mycosis fungoides from investigators' center an overall response of 65.22% at 9 months of treatment with topical chlormethine was recorded. Moreover in a recent multicenter greek study that included 58 patients with stage IA-IIB mycosis fungoides an overall response rate of 80.8% at 9 months of treatment was achieved. In the same study better response in patients with patches in comparison to plaques or tumors was also depicted. Unfortunately, the occurrence of skin drug reactions was the leading cause of treatment discontinuation in studies evaluating chlormethine irrespective of drug formulation, negatively affecting the achievement of a therapeutic response. In investigators' study, severe dermatitis was one of the main causes of treatment discontinuation, occuring in 15.5% of patients.
Taper of application frequency (as per SmPC) and topical steroid use represent strategies allowing the management of dermatitis in order to maintain patients on CL gel treatment and prevent treatment discontinuation. The presence or severity of dermatitis in the study population was not associated with ORR, indicating that the development of dermatitis did not affect the likelihood of response. It has previously been suggested that dermatitis may be a prognostic indicator for clinical response. These data highlight the unmet need to explain the significance of dermatitis after topical chlomethine application and the immunological changes behind and how these affect the clinical response. Additionally by standardizing a CyTOF technique in CTCL samples from skin biopsies of CTCL patients, investigators established the methodology for identification and enumeration of different cells populations in situ and their interactions with tumor microenvironment. Investigators' preliminary data demonstrated that the evaluation of MF-CTCL patients' immune profile revealed differences in cell proportion pinpointing the heterogeneity that characterizes different stages of MF.
Based on investigators' clinical and biological results investigators would like to further examine the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.
RESEARCH OBJECTIVES (CLINICAL, BIOLOGICAL AND PATIENT-REPORTED OUTCOMES - QUALITY OF LIFE) 3.1 Clinical objectives
3.1.1 Effectiveness of CL gel treatment in routine medical practice in MF patients by:
3.2.1 Assessments Dermatitis occurrence (before any topical steroids application) Clinical response (at least score >50% improvement from baseline) At months 6 and 12
3.4 Study Population MF patients treated with CL gel as monotherapy. Study design is presented in figure below.
This study will include 40 patients treated with CL gel as monotherapy.
Patients will discontinue study treatment permanently if the following condition is met:
All patients will be assessed every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice.
In case of dermatitis, the patient is encouraged to continue treatment with reduced frequency at every other day or every third day. Steroids will be used only if the reduced schedule is not sufficient. A temporary treatment interruption might occur for a period of 2 weeks and then treatment can be restarted.
3.5 Research objectives (detailed) Clinical, biological and patient quality of life 3.5.1 Clinical objective
For this part of the study the percentage change of malignant and inflammatory cells, profile of inflammatory (new and existing) and malignant cells in all MF patients treated with chlormethine gel (with or without dermatitis), cytokines and signaling pathways at a single cell level will be also measured at:
Baseline
o Dermatitis occurrence (before any topical steroids application)
Skin histology description, immunohistochemistry and PCR are used in clinical routine practice to assess malignant T cells and clonality.
The exploratory study will use both blood samples and skin biopsies taken as per routine management of the patients tests for the study of • CL gel mechanism of action (1)
We will correlate the above with the clinical effectiveness of CL gel treatment (3) as well as dermatitis occurrence and clinical response in MF patients (4).
More specifically
The signaling pathways involved, such as JAK/STAT, NF-κB, AKT, MAP kinases by identifying the phosphorylation status of implicated proteins by Western blot analyses
3.7 Patient-Reported Outcomes - quality of life (SKINDEX-29) Definition: Quality of Life (QoL) change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the SKINDEX-29 at every visit.
The Skindex-29 is a skin disease-specific questionnaire that comprehensively assesses the effects of skin diseases on patient's quality of life. It was specifically developed to detect changes throughout time, as well as differences among patients with different skin diseases. The questionnaire covers areas considered crucial in an instrument designed to evaluate quality of life, such as: degree of symptoms, psychosocial functioning, and emotional status. The 29-item version is a refinement of a previous 61-item version. It was originally written in English and has already been translated and validated in other languages. The Skindex-29 inquiries about how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. Seven items address the Symptoms domain, ten items the Emotional domain, and twelve items the Functioning domain. All responses are transformed to a linear scale of 100 varying from 0 (no effect) to 100 (effect experienced all the time). Skindex scores are reported as three scale scores, corresponding to the three domains; a scale score is the average of a patient's responses to items in a given domain.
Five distinct categories for the Symptoms scale, and four for the Emotions and Functioning scales have been categorized as summarized in the table below:
Emotional Symptoms Functioning Very little \<6 \<4 \<4 Mild 6-24.9 4-10.9 4-10.9 Moderate 25-49.9 11-25.9 11-32.9 Severe ≥50 26-49.9 ≥33 Extreme ≥50
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 51 observational studies indexed under Mycosis Fungoides.
Browse Mycosis Fungoides studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
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MF-CTCL patients, from outpatient PCL clinic from Attikon University Hospital, who will be candidates for topical treatment with chlormethine gel will be informed and invited to participate in this prospective data collection. All clinical and biological investigations (including blood samplings and biopsies) will be prescribed and arranged as part of standard routine clinical practice at PCL center.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical objectives: Number of participants with treatment-related adverse events as assessed by CTCAEv4.0.
Number of participants with treatment-related adverse events as assessed by CTCAEv4.0.
Time frame: 12 months
Clinical objectives: Clinical response mSWAT
Clinical response mSWAT (at least score ≥50% improvement from baseline) every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice
Time frame: 12 months
Clinical objectives: Dermatitis occurrence
Dermatitis occurrence (before any topical steroids application)
Time frame: 12 months
Biological objectives: Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells
Determine and compare immune cells vs malignant cells at single cell level
Time frame: 12 months
Biological objectives:Evaluation of the impact of chlormethine gel treatment exhibits on the profile of cytokines
Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/Th2 cytokines (ELISA)
Time frame: 12 months
Biological objectives:Evaluation of the impact that CL gel treatment exerts on the major signaling pathways
Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB AKT, MAP signaling pathways (Western Blotting)
Time frame: 12 months
Patient-Reported Outcomes
Questionnaires of Quality of Life
Time frame: 12 months
Started Feb 2023 (actual). Primary completion is estimated for Feb 2025, 24 months after the start.
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