"Chlormethine" from_date:2012

Chlormethine gel for treating mycosis fungoides-type cutaneous T-cell lymphoma Chlormethine gel for treating mycosis fungoides-type cutaneous T-cell lymphoma Technology appraisal guidance Published: 18 August 2021 www.nice.org.uk/guidance/ta720 © NICE 2021. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Your responsibility Your and reduce the environmental impact of implementing NICE recommendations wherever possible. Chlormethine gel for treating mycosis fungoides-type cutaneous T-cell lymphoma (TA720)© NICE 2021. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of18Contents Contents 1 Recommendations

Ledaga (chlormethine) Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs

Chlormethine hydrochloride (Ledaga) - for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) 1 Published 10 May 2021 1 SMC2318 chlormethine hydrochloride 160 micrograms/g gel (Ledaga®) Recordati Rare Diseases UK Ltd 9 April 2021 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission under the orphan medicine process chlormethine hydrochloride (Ledaga®) is accepted for use within NHSScotland. Indication under review: for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients. In a single

Evaluating Response Trends of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: Analysis of Individual Patient Data From a Randomized Controlled Phase II Study to Facilitate Optimal Treatment Experiences. Chlormethine (CL) gel was approved for treatment of mycosis fungoides based on the pivotal 201 trial (NCT00168064). Data visualization from individual patients

Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data. Chlormethine gel was approved for treatment of mycosis fungoides, the most common cutaneous T-cell lymphoma, on the basis of results from study 201 and study 202. A post-hoc analysis of study 201 found interesting trends regarding improved efficacy of chlormethine gel vs ointment and noted a potential association between dermatitis and clinical response. To expand these results by performing a post-hoc analysis of study 202. Patients received chlormethine gel or ointment during study 201 (12 months) and higher-concentration chlormethine gel during study 202 (7-month extension). Response was assessed using Composite Assessment of Index Lesion Severity

Mechanism of action of chlormethine (CL) gel in mycosis fungoides. Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, is characterized by proliferation of malignant skin-tropic T-cells. Progression from early-stage disease (skin patches and/or plaques) to more advanced stages (cutaneous tumors, erythroderma, or extracutaneous involvement) occurs slowly and can according to patient needs and drug availabilities, following clinical recommendations. International consensus guidelines recommend skin-directed therapies (SDTs) as first-line treatment for early-stage disease, and SDTs combined with systemic therapy for advanced stages. Chlormethine (CL), also known as mechlorethamine, chlorethazine, mustine, HN2, caryolysine, and embichin, is a synthetic

Chlormethine (Ledaga) - mycosis fungoides-type cutaneous T-cell lymphoma 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged . 15 December 2016 EMA/CHMP/13156/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report LEDAGA International non-proprietary name: chlormethine Procedure No. EMEA/H/C/002826/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/653881/2017 Page 2/76 Table of contents 1

Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides. Treatment of early-stage mycosis fungoides (MF) requires safe, skin-directed therapies. Medication side effects can lead to underutilization of effective therapies. The objective of this study was to assess the use of topical triamcinolone 0.1% ointment as a means of reducing contact dermatitis associated with topical mechlorethamine/chlormethine gel for the treatment of MF. This prospective, randomized, open-label study evaluated 28 adults with mycosis fungoides who were eligible for treatment with topical mechlorethamine/chlormethine gel from December 17, 2017 to December 23, 2020. Patients were treated for 4

Chlormethine Gel is Efficient and Safe in Mycosis Fungoides Skin Lesions. Chlormethine is a bifunctional cytotoxic alkylating agent that binds to DNA, resulting in cell death (apoptosis). Chlormethine (also known as mechlorethamine) gel (CL gel) was approved in the European Union in 2017 and was first used in 2019. The aim of the study is to examine evidence regarding the efficacy and safety of chlormethine gel in everyday clinical experience from a cutaneous lymphoma centre. Twenty-three patients with stage IA-IIB mycosis fungoides received chlormethine gel between September 2020 and May 2021. All patients started by applying the gel daily and were monitored every month. At 1, 3, 6 and 9 months, 0%, 43.47%, 56.52% and 65.22% of patients, respectively, achieved an overall response. Five out of 23

Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Mycosis fungoides (MF) is the most common form of cutaneous T-cell lymphoma. Patients can be treated using chlormethine gel, a skin-directed therapy developed and approved for MF. In the randomized, controlled 201 trial , chlormethine gel was found to be noninferior to equal-strength chlormethine ointment. However, there remains a need to gain more insight into outcome measures after treatment. The aim of this study was to further investigate the potential of chlormethine gel treatment through a novel post hoc analysis of the 201 trial data (NCT00168064). Patients were randomized to chlormethine gel or ointment; response

Real-life experience with chlormethine gel for early-stage mycosis fungoides with emphasis on types and management of cutaneous side-effects(). Real-life efficacy data on the recently approved once daily application of chlormethine gel (CG) for mycosis fungoides (MF) is limited, and detailed characterization of the side effects and their management are strikingly sparse. To evaluate the efficacy

Chlormethine gel is effective for the treatment of skin lesions in patients with early- and late-stage mycosis fungoides in clinical practice. Chlormethine gel is a skin-directed therapy used for patients with mycosis fungoides (MF) that showed a favourable risk/benefit profile in a randomized clinical trial. Currently, data on chlormethine gel use in real-world settings are limited. The aim of this study was to assess safety and efficacy of chlormethine gel treatment in patients treated during daily clinical practice and investigate associations between response and disease stage, lesion type, mono- or combination therapy, and occurrence of dermatitis. Clinical data from patients using chlormethine gel from three sites in Greece were analysed. Efficacy was assessed through modified Severity

Evaluating the Treatment Patterns of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: By-time Reanalysis of a Randomized Controlled Phase 2 Study. The pivotal 201 Study investigated chlormethine/mechlorethamine gel treatment for patients with early stage disease mycosis fungoides and demonstrated the treatment was not inferior to chlormethine ointment. However , overall response rates do not provide information about response patterns. The study objective was to assess the value of by-time analysis of clinical response data in visualizing response over time. This post hoc analysis re-evaluated chlormethine efficacy using a by-time approach that investigated the trend to treatment response and permitted assessment of response, both monthly between 1 and 6 months

The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma. Chlormethine/mechlorethamine gel is a skin-directed therapy for patients with mycosis fungoides cutaneous T-cell lymphoma. Currently, real-world data on chlormethine gel are lacking. Our objective was to analyze the effect of chlormethine gel in combination with other therapies on efficacy, safety, and health-related quality of life in a real-world setting. This prospective, observational study enrolled adult patients actively using chlormethine gel. Patients were monitored for up to 2 years during standard-of-care clinic visits. No specific visit schedules or clinical assessments, with the exception of patient

The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients 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

REACH: Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) Adult patients with early stage MF-CTCL (stage IA-IB) will be eligible for this study. A total of 100 early stage MF-CTCL patients diagnosed in the past year will be enrolled.Treatment with CL gel will be applied once daily to all skin areas

or pharmacist. Expand sectionCollapse sectionWhat is Ledaga and what is it used for?Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma. The medicine contains the active substance chlormethine. Because the number of patients with this skin cancer is low, the disease is considered ‘rare’, and Ledaga was designated an ‘orphan medicine’ (a medicine . For further information, see the package leaflet. How does Ledaga work?The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents’. Alkylating agents work by attaching to the DNA of cells while the cells are dividing. As a result, cancer cells cannot divide and they eventually die. What benefits of Ledaga have been shown in studies?The company provided

Systemic Targeted Therapies in Patients with Relapsed/Refractory Advanced Stage Cutaneous T-cell Lymphoma: A Real-world Single-centre Case Series. Cutaneous T-cell lymphomas are a heterogeneous group of non-Hodgkin lymphomas. Early stages are often controlled with skin-directed therapy, such as topical corticosteroids, topical chlormethine gel, or UV therapy, whereas advanced stages often warrant

, fertility, infertility, fecundity, ovarian reserve, ovarian function, menopause, decreased ovarian reserve, premature ovarian insufficiency/failure), and terms related to chemotherapy (cyclophosphamide, lfosfamide, chlormethine, chlorambucil, busulfan, melphalan, procarbazine, cisplatin, doxorubicin, carboplatin, taxane, paclitaxel, docetaxel, 5-fluorouraci, vincristine, methotrexate, dactinomycin

version include the incorporation of chlormethine, brentuximab vedotin, and mogamulizumab, recommendations on the use of pegylated interferon α (after withdrawal of recombinant unpegylated interferons), and the addition of paragraphs on supportive therapy and on the care of older patients. Still, skin-directed therapies are the most appropriate option for early-stage MF and most patients have a normal