Clinical trial · Interventional

Topical JAK-Inhibition of Early-Stage CTCL

An Investigator-Initiated, Descriptive, Proof-of-Concept, Open-Label Pilot Study Focusing on Topical JAK Inhibition as a Novel Treatment of Cutaneous T-Cell Lymphoma

NCT07781449CI-TRIAL-00123798not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study tests whether a cream named delgocitinib (Anzupgo), applied twice daily to the skin, is safe and well tolerated in people with early-stage cutaneous T-cell lymphoma (a rare type of skin cancer called mycosis fungoides). The cream works by blocking proteins called JAK enzymes, which are involved in inflammation and cancer cell growth in the skin. Delgocitinib cream is already approved for treating chronic hand eczema, but it has not yet been studied in people with cutaneous T-cell lymphoma. In this study, up to 15 participants with stable, early-stage disease will apply the cream to their affected skin for 16 weeks. Researchers will closely monitor for side effects and also look at whether the cream improves skin symptoms, such as itching and the appearance of the skin. Participants will be followed for 4 additional weeks after treatment ends. This is an early, exploratory study (a "proof-of-concept" trial) designed mainly to check safety, not to prove that the treatment works. The findings will help researchers decide whether to test this cream in larger studies in the future.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cutaneous T-cell Lymphoma	Primary Cutaneous T-Cell Non-Hodgkin Lymphoma	ALIAS	0.90
Mycosis Fungoides	Mycosis Fungoides	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
delgocitinib	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Delgocitinib
description
Participants apply delgocitinib 20 mg/g cream (Anzupgo) topically to affected skin areas twice daily for 16 weeks.
interventionNames
1. Drug: delgocitinib

Primary outcomes (1)

measure
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Safety and Tolerability of Topical Delgocitinib]
timeFrame
From baseline (day 0) to end of treatment week 16 (day 112)
description
Severity and causal relationship to study treatment will be assessed for all TEAEs and SAEs. Local tolerability will be evaluated based on application-site reactions. Vital signs, physical examination findings, and laboratory parameters will be assessed for clinically relevant abnormalities

Secondary outcomes (7)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Men or women aged 18 or older at the time of consent
* Histologically confirmed diagnosis of mycosis fungoides (stage IA, IB, or IIA)
* Stable disease requiring palliative treatment
* No change in medication for 2 months prior to study entry
* Willing and able to give informed consent, obtained prior to any study-related procedures

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients (Benzyl alcohol, Butylhydroxyanisole, Cetostearyl alcohol)
* Sézary syndrome (cancerous T-cells found in the blood)
* Concomitant treatment with other topical/skin-directed therapies (phototherapy, radiotherapy, chlormethine gel, topical corticosteroids)
* Psychiatric illness, disability, or social situation that would compromise subject safety or ability to provide consent
* History of non-melanoma skin cancer (NMSC)
* Atopic dermatitis or other clinically relevant dermatological diseases
* Other clinically significant medical conditions, including:
* Ongoing skin infections requiring antibiotics
* Physical, laboratory, or vital sign abnormalities that would, in the investigator's opinion, put the subject at undue risk or interfere with interpretation of study results
* Pregnancy or breastfeeding
* Women of childbearing potential must use a highly effective contraceptive method

References

Publications (32)

BACKGROUNDOken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. PMID 7165009
BACKGROUNDOlsen E, Vonderheid E, Pimpinelli N, Willemze R, Kim Y, Knobler R, Zackheim H, Duvic M, Estrach T, Lamberg S, Wood G, Dummer R, Ranki A, Burg G, Heald P, Pittelkow M, Bernengo MG, Sterry W, Laroche L, Trautinger F, Whittaker S; ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007 Sep 15;110(6):1713-22. doi: 10.1182/blood-2007-03-055749. Epub 2007 May 31. PMID 17540844
BACKGROUNDSoerensen SBT, Nagy D, Odum N, Iversen L, Lindahl LM. Chronic Obstructive Pulmonary Disease and Risk of Cutaneous T-cell Lymphoma: A Danish Population-based Cohort Study. Acta Derm Venereol. 2023 Aug 22;103:adv5238. doi: 10.2340/actadv.v103.5238. No abstract available. PMID 37606154
BACKGROUNDFredholm S, Willerslev-Olsen A, Met O, Kubat L, Gluud M, Mathiasen SL, Friese C, Blumel E, Petersen DL, Hu T, Nastasi C, Lindahl LM, Buus TB, Krejsgaard T, Wasik MA, Kopp KL, Koralov SB, Persson JL, Bonefeld CM, Geisler C, Woetmann A, Iversen L, Becker JC, Odum N. SATB1 in Malignant T Cells. J Invest Dermatol. 2018 Aug;138(8):1805-1815. doi: 10.1016/j.jid.2018.03.1526. Epub 2018 May 8. PMID 29751003
BACKGROUNDMunir S, Andersen GH, Woetmann A, Odum N, Becker JC, Andersen MH. Cutaneous T cell lymphoma cells are targets for immune checkpoint ligand PD-L1-specific, cytotoxic T cells. Leukemia. 2013 Nov;27(11):2251-3. doi: 10.1038/leu.2013.118. Epub 2013 Apr 18. No abstract available. PMID 23660624
BACKGROUNDKrejsgaard T, Vetter-Kauczok CS, Woetmann A, Kneitz H, Eriksen KW, Lovato P, Zhang Q, Wasik MA, Geisler C, Ralfkiaer E, Becker JC, Odum N. Ectopic expression of B-lymphoid kinase in cutaneous T-cell lymphoma. Blood. 2009 Jun 4;113(23):5896-904. doi: 10.1182/blood-2008-09-181024. Epub 2009 Apr 7.