Observatory of Prolymphocytic Leukemia T

Study acronym: T-PLL
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Minor Enrollment closed, study ongoing
    • Study completion moved earlier from Jul 30, 2028 to Dec 31, 2027
    • Site details revised
    • Eligibility criteria expanded, about 3 words
  2. Notable Primary completion date: Dec 30, 2025 to Jul 30, 2026
    • Study completion date: Jun 30, 2026 to Jul 30, 2028
    v7
  3. Notable Primary completion date: Jun 30, 2025 to Dec 30, 2025
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v6
  4. Notable Primary completion date: Jun 30, 2023 to Jun 30, 2025
    • Study completion date: Jun 1, 2025 to Jun 30, 2025
    v5
  5. Notable Primary completion date: Jun 1, 2025 to Jun 30, 2023v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2020 to Jul 1, 2020
    v3
  2. Minor Start date: Jun 1, 2020 to Jun 30, 2020v2
  1. Minor Study First Submitted
  • 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.
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-. The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1. On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis. Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 . Main objective: Better manage prolymphocytic T leukemias. Secondary objectives: * Molecular characterization of prolymphocytic leukemia T. * Study of the response to treatment, disease-free survival, overall survival. * Impact of prognostic factors on response to treatment, and survival.
Trial Details
NCT Number NCT04411043
Lead Sponsor French Innovative Leukemia Organisation
Collaborators: University Hospital, Lille
Conditions
(from sponsor)
Prolymphocytic Leukemia, T-cell Leukemia
Related terms Leukemia, Prolymphocytic, Leukemia, T-Cell
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov