Observatory of Prolymphocytic Leukemia T

NCT04411043 | Recruiting

• 1 other identifier: T-PLL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolymphocytic Leukemia; T-cell Leukemia

Outcome Measures

Primary Outcomes (4)

• Clinical characteristics of prolymphocytic leukemia T

  pathology description at diagnosis and its evolution over time

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

• Biological characteristics of prolymphocytic leukemia T

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

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

• Flow cytometry data of bone marrow and blood cells

  Positive or negative immunophenotyping

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

• karyotype of tumor cells

  karyotipic formula

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

Interventions

Molecular caracterization BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with prolymphocytic T leukemia

You may qualify if:

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

You may not qualify if:

• Absence of signature of informed consent

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• University Hospital, Lille: collaborator

Study Sites (1)

Chd Le Mans

Le Mans, 72000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow and peripheral blood cells

MeSH Terms

Conditions

Leukemia, Prolymphocytic; Leukemia, T-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kamel LARIBI, Dr

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles HERBAUX, Dr

CONTACT

3 20 44 57 13; Charles.herbaux@chru-lille.fr

Alexandra FAYAULT

CONTACT

a.fayault@filo-leucemie.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 2, 2020
• Study Start: July 1, 2020
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)