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BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma — BIOSELECT  

Mycosis Fungoides Clinical Trial

Official title:
An Interventional, Single-arm, Open-label Phase I/II Study Investigating the Efficacy and Safety of Anti-PD1 Immunotherapy for the Treatment of Patients With Cutaneous T-cell Lymphoma (Mycosis Fungoides)

Clinical Trial Summary

Background - Advanced cutaneous T-cell lymphoma (mycosis fungoides, MF) is an incurable extranodal mature lymphoma with poor prognosis. Currently available therapies provide only short-term remissions. Rationale - MF is an immunogenic cancer and expresses a high number of neoantigens. therefore it it reasonable to assume that it would respond to immune checkpoint inhibitors. Objectives - The primary objective is to test the clinical efficacy (objective response rate) of the immune checkpoint inhibitor cemiplimab in patients with advanced mycosis fungoides (MF) who failed first-line therapy, defined as the sum of complete and partial responses (where at least 50% reduction of mSWAT is achieved).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05538988
Study type Interventional
Source AHS Cancer Control Alberta
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date December 2024
Completion date March 2026
View Details
See also
  Status Clinical Trial Phase
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Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Terminated NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
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Completed NCT02883517 - Cell-free Circulating DNA in Primary Cutaneous Lymphomas
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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
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Recruiting NCT05414500 - Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides Phase 1