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NCT Number: NCT04411043

Observatory of Prolymphocytic Leukemia T

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.

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Key information

Conditions

Prolymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Prolymphocytic Leukemia, T-Cell Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type T-cell Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman aged 18 or over
  • Patient with prolymphocytic T leukemia

Exclusion criteria

  • Absence of signature of informed consent

Treatment and study plan

Molecular caracterization

Behavioral

Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T

Primary outcomes

  1. Clinical characteristics of prolymphocytic leukemia T

    Time frame: from day 0 through study completion, an average of 3 years

    pathology description at diagnosis and its evolution over time

  2. Biological characteristics of prolymphocytic leukemia T

    Time frame: At day 0 and at relapse, an average of 3 years

    Blood count : Hemoglobin, Leukocytes, Lymphocytes, Platelets, Eosinophils (giga / liters)

  3. Flow cytometry data of bone marrow and blood cells

    Time frame: At day 0 and at relapse, an average of 3 years

    Positive or negative immunophenotyping

  4. karyotype of tumor cells

    Time frame: At day 0 and at relapse, an average of 3 years

    karyotipic formula

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra FAYAULT

CONTACT

[email protected]

Charles HERBAUX, Dr

CONTACT

[email protected]

3 20 44 57 13 ext. +33

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

  • University Hospital, Lille

Registry information

Official study title

Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.

Acronym: T-PLL

Important dates

Study start
2020
Primary completion
2026
Study completion
2028
First posted
Jun 2, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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