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Disease

Mycosis Fungoides

Late-stage therapeutic developmentEmerging research
MeSHMycosis Fungoides
1
Publications
18
Clinical trials
2024
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 5 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
Clinical Milestones9View all 9
Results posted 1
Results expected 5
Recently completed 2
Other updates 1
+1 more in the activity timeline below
Activity timeline9

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Mogamulizumabapproved

Approval — Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or… (2018)

Clinical trials

16 sponsors · 1 new · 1 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
18
All trials
6
Active
6
Late-stage
6
Completed
Late-stage studies

A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Phase 3 · Recruiting · Soligenix

A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB

Phase 3 · Completed · Medical University of Graz

UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A

Phase 4 · Completed · M.D. Anderson Cancer Center

A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma

Phase 3 · Terminated · Elorac, Inc.

Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

Phase 3 · Terminated · Emergent Product Development Seattle LLC

Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.

Phase 4 · Terminated · Madrilenian Group of Cutaneous Lymphomas
Recruiting

A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Phase 3 · Recruiting · Soligenix

THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study

Phase 2 · Recruiting · Columbia University

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

Phase 2 · Recruiting · City of Hope Medical Center

Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Phase 2 · Recruiting · Memorial Sloan Kettering Cancer Center

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Phase 2 · Recruiting · Stanford University
Recently completed

Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light

Phase 2 · Completed · Ellen Kim, MD

A Phase II, Open-Label, Single-Arm Trial Using KEYTRUDA (Pembrolizumab) as Initial Systemic Therapy in the Treatment of Advanced Mycosis Fungoides

Phase 2 · Completed · Mayo Clinic

A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

Phase 2 · Completed · Affimed GmbH

A Phase II Trial of MK-3475 (Pembrolizumab) and Interferon Gamma 1-b Combination Immunotherapy in Patients With Previously Treated Mycosis Fungoides and Sezary Syndrome (Treatment Group 1) and in Patients With Advanced Synovial Sarcoma (Treatment Group 2)

Phase 2 · Completed · National Cancer Institute (NCI)

A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB

Phase 3 · Completed · Medical University of Graz

UVADEX Sterile Solution in Conjunction With the UVAR XTS Photopheresis System as an Interventional Therapy for the Treatment Of CTCL (Mycosis Fungoides) in Patients With TMN Classification Stage 1A, 1B, 2A

Phase 4 · Completed · M.D. Anderson Cancer Center

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2018emaApproval — Mogamulizumab· Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Major themes4
  • Lymphoma, T-Cell, Cutaneous1
  • Mycosis Fungoides1
  • Sezary Syndrome1
  • Skin Neoplasms1
Leading journals1
  • Cells1
Leading researchers6
  • Agostinelli C1
  • Guglielmo A1
  • Motta G1
  • Pileri A1
  • Sabattini E1
  • Zengarini C1
Affiliations (unnormalised)3
  • Institute of Dermatology1
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna1
  • University of Bologna1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A chronic, malignant T-cell lymphoma of the skin. In the late stages, the LYMPH NODES and viscera are affected.

Identifiers
MeSHMycosis Fungoides
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.