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Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

Study acronym: MOGAT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Study sites: 11 to 13v11
  2. Minor Study sites: 10 to 11v10
  3. Minor Study sites: 8 to 10v9
  4. Minor Study sites: 7 to 8v8
  5. Minor Study sites: 3 to 7
    • Start date changed from estimate of Mar 2023 to Mar 7, 2023
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Study sites: 2 to 3v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2022 to Mar 2023
    • Study sites: 0 to 2
    v5
  3. Notable Start date: Apr 2021 to Sep 2022v4
  4. Minor Secondary endpoints revised (7)v3
  5. Notable Primary completion date: Oct 2025 to Oct 2026v2 Show 5 more changesShow less
    • Start date: May 2020 to Apr 2021
    • Primary endpoint revised
    • Study completion date: Jan 2026 to Jan 2027
    • Secondary endpoints: 1 to 7
    • Eligibility criteria shortened, about 5 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cutaneous T-Cell Lymphoma (CTCL) has a chronic, relapsing course with patients undergoing multiple, consecutive therapies. Treatment aims at the clearance of skin disease, minimization of recurrence, prevention of disease progression and preservation of quality of life. The treatment of CTCL is primarily determined by the disease extent. Prolonged complete remissions have been obtained with skin-directed therapies in early stage Mycosis fungoides (MF) (IA-IIA), whereas advanced stages CTCL (IIB-IVB) are often refractory to treatment and, thus, have an unfavorable prognosis. Currently, there is no standard treatment option for CTCL, especially for advanced stages, and the optimal treatment sequence is still debated with a large variability in the therapeutic approach across countries. Patients with advanced-stage disease or refractory cutaneous CTCL should be treated with systemic therapies and, whenever possible, should be offered to participate in clinical trials. Currently, there is a urgent call for new treatments in CTCL with higher response rate and prolonged time to progression; In this study, we propose a very innovative treatment schedule in which mogamulizumab is used before Total Skin Electron Beam therapy (TSEB) for systemic disease control and as a maintenance treatment after skin-directed therapy. We hypothesize that our regimen will show a more manageable toxicity profile than a combination treatment and allow for a long-term mogamulizumab administration.
Trial Details
NCT Number NCT04128072
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)
Stage IB-IIB Cutaneous T-Cell Lymphoma
Related terms Lymphoma, T-Cell, Cutaneous
Enrollment 43 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov