Clinical Trials Logo
  1. Home
  2. Mycosis Fungoides
  3. NCT05205902

TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides — TOTEM-01  

Mycosis Fungoides Clinical Trial

Official title:
TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides: a Prospective Randomized Controlled Study

Clinical Trial Summary

Primary cutaneous T-cell lymphomas are a group of peripheral T-cell lymphomas that primarily involve the skin. Mycosis fungoides (MF) is the most frequent subtype. Most patients with early-stage MF (i.e., patches and plaques of the skin without extracutaneous involvement) have a good prognosis but a subset of patients progress to incurable advanced-stage disease with an overall survival (OS) less than 5 years and an impaired quality of life. We have recently identified the tumor clone frequency in lesional skin (measured by high-throughput sequencing of the TCRB locus) as the most important prognostic factor of progression-free survival (PFS) and OS in a retrospective analysis on 210 patients with early-stage MF (p<0.001). Phototherapy is a standard therapeutic option in early-stage MF but fails to eradicate the tumor clone from the skin. Low-dose total-skin electron-beam therapy (LDTSEBT, 12 Gy over a 3-week period) has been shown to be safe and highly effective in MF with an 88% overall response rate and a better safety profile compared to standard-dose total-skin electron-beam therapy, in a pooled analysis from 3 phase II trials on 33 patients and a retrospective analysis of 12 patients treated with LDTSEBT. We hypothesize that the use of LDTSEBT is associated with a significantly higher 1-year PFS compared to conventional treatment with phototherapy. Our secondary hypotheses are that LDTSEBT is associated with a higher tumor T-cell clone eradication compared to phototherapy, and improves OS and quality of life in patients with skin-limited MF. The main objective of this study is therefore to prospectively determine if LDTSEBT is associated with a higher 1-year progression-free survival in patients with early-stage mycosis fungoides, compared to conventional treatment with phototherapy. The primary endpoint is PFS at 12 months after study inclusion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05205902
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Adèle DEMASSON
Phone +33171 20 75 01
Email adele.demasson@aphp.fr
Status Not yet recruiting
Phase Phase 3
Start date February 2022
Completion date February 2031
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Not yet recruiting NCT02881749 - Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides Phase 2
Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Recruiting NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
Completed NCT01590732 - Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma Phase 1
Recruiting NCT02848274 - ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
Recruiting NCT00177268 - Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Recruiting NCT05357794 - Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides Phase 2
Completed NCT04955340 - A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Phase 1
Recruiting NCT04960618 - Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome Phase 2
Completed NCT02883517 - Cell-free Circulating DNA in Primary Cutaneous Lymphomas
Active, not recruiting NCT02953301 - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Phase 2
Completed NCT00254332 - Effect of Denileukin Diftitox on Immune System in CTCL Patients N/A
Completed NCT02296164 - Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
Recruiting NCT05680558 - Photopheresis in Early-stage Mycosis Fungoides Phase 2
Completed NCT00038376 - Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies Phase 2
Completed NCT00168064 - Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides Phase 2
Recruiting NCT05879458 - Ritlecitinib in CTCL Phase 2
Recruiting NCT05904522 - Histopathological Changes in Mycosis Fungoides N/A
Recruiting NCT05414500 - Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides Phase 1