Valchlor (mechlorethamine gel) / Helsinn, Recordati, Juniper Bio - LARVOL DELTA

Real-world data on the use of Ledaga gel in Germany (ADO 2026) - "Sponsored by Recordati Rare Diseases Germany GmbH."

Clinical • Real-world • Real-world evidence • Rare Diseases

Pediatric Mycosis Fungoides and Hydroa Vacciniforme Lymphoproliferative Disorder. (PubMed, Cancers (Basel)) - "Adaptations include limiting unnecessary ionizing radiation, relying more heavily on ultrasound as an imaging modality, and balancing disease control with the long-term safety of treatments, including topical corticosteroids and mutagenic therapies such as PUVA, mechlorethamine gel, and radiation...Although HV-LPD is a distinct Epstein-Barr virus--associated entity rather than a variant of MF, it is included here because it is one of the few primary cutaneous lymphoproliferative disorders of childhood. It therefore shares the diagnostic challenges of mimicking benign dermatoses and requiring careful clinicopathologic and immunophenotypic correlation, and represents an important consideration in the pediatric differential diagnosis."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Pediatrics • T Cell Non-Hodgkin Lymphoma

StrataCTX® as a Steroid Sparing Device (clinicaltrials.gov) - P=N/A | N=70 | Recruiting | Sponsor: Columbia University | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Lymphoma

Erythrodermic Mycosis Fungoides with Palmoplantar Keratoderma and Nail Dystrophy: A Case Report (EADV-Sp 2026) - "Previous reports suggest variable efficacy of radiotherapy, phototherapy, CO₂ laser, and methotrexate, whereas topical corticosteroids, acitretin, and bexarotene appear less effective for palmoplantar MF. No standardized treatment guidelines exist for MF-related nail disease, therapeutic options are limited to topical corticosteroids, retinoids, or nitrogen mustard, with inconsistent outcomes. Palmoplantar and nail involvement, though rare, should raise suspicion for MF, particularly in erythrodermic patients even in the absence of Sézary syndrome criteria. Optimal management may require a multimodal approach combining systemic therapy with targeted treatments for resistant acral sites, along with long-term maintenance to prevent relapse"

Case report • Clinical • Cutaneous T-cell Lymphoma • Dermatology • Dermatopathology • Hematological Malignancies • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • CD4 • CD7 • CD8

Results from a Pilot Study of HyBryte™ (Topical Synthetic Hypericin) Versus Valchlor® (Mechlorethamine) in the Treatment of CTCL. (PubMed, Oncol Ther) - P2 | "This is a single-center, open-label study. It is a pilot study requiring additional research to confirm its results. This study demonstrated the favorable safety and efficacy profile of HyBryte™ compared to Valchlor® in patients with CTCL. HyBryte™ showed higher treatment success rates and was better tolerated."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Oral Bexarotene as a First-Line Systemic Therapy for Cutaneous T-Cell Lymphoma (AAD 2026) - "Eligible patients had failed initial skin-directed therapies (e.g., phototherapy, topical bexarotene, mechlorethamine gel) and subsequently received oral bexarotene. Our findings suggest that oral bexarotene is efficacious and safe as a first-line systemic option for CTCL refractory to skin-directed therapies. Further prospective studies are warranted to confirm these results and refine treatment strategies."

Clinical • Constipation • Cutaneous T-cell Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma

Topical hypericin: a promising photodynamic therapy for early-stage cutaneous T-cell lymphoma. (PubMed, Expert Opin Investig Drugs) - "Topical photodynamic therapy with synthetic hypericin (research name: SGX301; trade name: HyBryte™) has emerged as a novel agent addressing this gap...Minimal local adverse events and limited systemic absorption offer a key long-term safety advantage over conventional phototherapies. Its effectiveness in both patch and plaque lesions makes it a versatile tool, improving outcomes and quality of life for patients."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Clinical Validation of Imaging Biomarkers in Mycosis Fungoides. (PubMed, Exp Dermatol) - "Sixty-six participants were enrolled in two prospective studies: a cross-sectional discovery cohort to assess baseline characteristics of 35 MF patients (IA-IVB) and 10 healthy controls using CAILS and MSI, and a longitudinal confirmation cohort including 21 early-stage MF patients (IA-IIA) treated with chlormethine gel 0.016% for 16 weeks, in whom lesional and non-lesional skin were assessed using CAILS, MSI, colourimetry and LSCI at multiple time points...These biomarkers reliably discriminated lesional from non-lesional skin (p ≤ 0.001), showed strong test-retest reliability (CV  0.84), detected treatment effects, showed moderate concordance with CAILS, and were associated with low patient burden (mean 3.4/100). These findings show that MSI- and colourimetry-derived biomarkers can objectively monitor disease extent in MF and complement existing clinical assessments."

Biomarker • Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Management of Mycosis Fungoides With Chlormethine Hydrochloride Gel in Combination With Systemic Therapies: A Case Series. (PubMed, Case Rep Dermatol Med) - "All patients were treated with chlormethine hydrochloride gel in combination with other skin-directed and systemic therapies, including bexarotene, methotrexate, topical steroids, extracorporeal photopheresis, donor lymphocyte infusion and interferon-α (IFN-α) 2a...The combination regimens were generally well tolerated, with associated adverse events being inflammation, pruritus and erythema. This case series reports on the efficacy and safety of chlormethine hydrochloride gel in combination with other topical and systemic therapies in reducing the skin lesion severity in patients with Stage I-IV MF in different real-world settings."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • Pruritus • T Cell Non-Hodgkin Lymphoma • IFNA1

Chlormethine gel use in mycosis fungoides: could contact dermatitis predict outcomes? (PubMed, Ital J Dermatol Venerol) - No abstract available

Biomarker • Journal • Contact Dermatitis • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Immunology • Mycosis Fungoides • Oncology

Utilization and cost trends of topical mechlorethamine for cutaneous T-cell lymphoma in the United States: A Medicare part d analysis (ASH 2025) - "Valchlor remains a valuable therapy for CTCL; however, its rising cost and variable prescribing patterns warrant closer scrutiny, suggesting opportunities to improve prescribing practices and reduce overall costs. These data provide a foundation for further evaluation of real-world usage and can inform future value-based care strategies in CTCL management."

Medicare • Reimbursement • US reimbursement • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma

Stratum corneum ceramide profile as biomarker in cutaneous T-cell lymphoma (ISDS 2025) - "Treatment with chlormethine gel resulted in a partial normalization of the ceramide profile. To conclude, MF lesions exhibit a distinct and altered ceramide profile compared to non-lesional and healthy skin, which can partially be restored with topical treatment, qualifying ceramide profiling with tape-stripping as biomarker for disease monitoring."

Biomarker • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • T Cell Non-Hodgkin Lymphoma

Predicting response to topical chlormethine treatment in early-stage Mycosis Fungoides: optical coherence tomography vs. histology (ISDS 2025) - "Patients applied chlormethine gel for 16 weeks...In conclusion, OCT reliably measures epidermal thickness and correlates with clinical and histological findings. Our results suggest that epidermal thickness correlates with clinical response to chlormethine, thereby supporting its role as a non-invasive tool for monitoring therapeutic response."

Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Chlormethine gel effectiveness as second-line treatment in mycosis fungoides: a single-centre retrospective study. (PubMed, Discov Oncol) - "Chlormethine gel appeared to be efficacious and safe as a second-line treatment for MF, including in advanced stages. Despite limitations like small sample size and retrospective design, these findings highlight its potential in combination therapies and the importance of continued treatment for optimal outcomes. Future research should confirm these results in larger, prospective studies."

Journal • Retrospective data • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Hematological Malignancies • Immunology • Lymphoma • Mycosis Fungoides • Oncology

An Unusual Presentation of Mycosis Fungoides with Elevated Serum Tryptase (ACAAI 2025) - "He was initiated on omalizumab for persistent urticaria with partial improvement...He started treatment with mechlorethamine, showing good response...Discussion Although MF has not been associated with elevated tryptase levels, this patient’s persistently elevated tryptase with a negative evaluation for systemic mastocytosis raises questions about a potential association. This case also highlights the importance of thorough evaluations in patients with benign appearing, but persistent and refractory rashes, as conditions like MF may be overlooked."

Cardiovascular • Cutaneous T-cell Lymphoma • Dermatitis • Dermatology • Immunology • Mycosis Fungoides • Oncology • Urticaria • KIT

Chlormethine Gel Response and Dermatitis-Associated Modulation of the Tumor Microenvironment in Early-Stage MF (EORTC-CLTG 2025) - No abstract available

Biomarker • Tumor microenvironment • Oncology

Real-world experience with Chlormethine gel for Mycosis Fungoides treatment: results from a UK centre (EORTC-CLTG 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Oncology

Chlormethine gel experience from Kuwait Cancer Control Center (KCCC) (EORTC-CLTG 2025) - No abstract available

Oncology

Lipidomic profiling in cutaneous T-cell lymphoma: Comparative analysis of ceramide composition and treatment effect (EADV 2025) - "To conclude, MF lesions exhibit a distinct and altered ceramide profile compared to non-lesional and healthy skin, which can partially be restored with topical treatment."

Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Effective Use of Mogamulizumab in CD30+ Large Cell Transformed Mycosis Fungoides: A Case of Early Remission (EADV 2025) - "Materials & Methods/Case presentation: We report a case of a 66-year-old male with a 10-year history of MF (stage T2bN0M0B0 at diagnosis), managed with multiple lines of therapy including PUVA, UVB, bexarotene, topical nitrogen mustard (Mustargen), chlormethine gel (Ledaga), and methotrexate—all with partial or no sustained response. Although Brentuximab vedotin remains a first-line option for CD30+ LCT-MF, this case illustrates the potential of mogamulizumab to induce both hematologic and unexpectedly rapid cutaneous responses, even in transformed disease. To our knowledge, this is the first report demonstrating successful use of mogamulizumab in a patient with CD30+ LCT-MF with rapid response both in blood and skin. Mogamulizumab may represent a safe and effective alternative in select refractory cases."

Clinical • Cutaneous T-cell Lymphoma • Dermatology • Mycosis Fungoides • Oncology • CCR4 • TNFRSF8

Comprehensive characterization of the stratum corneum ceramide profile in cutaneous T-cell lymphoma (ESDR 2025) - "Treatment with chlormethine gel resulted in a partial normalization of the ceramide profile. To conclude, MF lesions exhibit a distinct and altered ceramide profile compared to non-lesional and healthy skin, which can partially be restored with topical treatment."

Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • T Cell Non-Hodgkin Lymphoma

Clinical and cellular effects of chlormethine gel in patients with cutaneous T-cell lymphoma of the mycosis fungoides type as mono- and combination therapy (ADO 2025) - No abstract available

Clinical • Combination therapy • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Update on the mechanism of action and possible uses of chlormethine gel (ADO 2025) - "Sponsored by Recordati Rare Diseases Germany"

Rare Diseases

Topical Chlormethine Gel in the Treatment of Lymphomatoid Papulosis: A Case Report and Literature Review. (PubMed, J Clin Med) - "Six months post-treatment, the patient remained in remission. This case underscores the effectiveness of CG in achieving sustained remission in acral LyP, suggesting its potential as a treatment option for this rare condition."

Journal • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Skin-Directed Therapies in Mycosis Fungoides: An Update. (PubMed, Dermatol Ther (Heidelb)) - "This review provides an updated overview of SDTs in MF treatment, including topical agents such as corticosteroids, retinoids, mechlorethamine, carmustine, imiquimod, as well as photodynamic therapy (PDT); phototherapy modalities including narrowband UVB (nb-UVB) and psoralen-UVA (PUVA); local radiotherapy; total skin electron beam radiotherapy (TSEBT) and total skin helical tomotherapy (TSHT). We review the indications, mechanisms of action, efficacy data, and adverse effect profiles associated with both established and emerging SDTs. Additionally, we present ongoing clinical trials evaluating emerging SDTs in the treatment of MF."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma