Observatory of Prolymphocytic Leukemia T

NCT ID: NCT04411043

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prolymphocytic Leukemia T-cell Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Molecular caracterization

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Absence of signature of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

University Hospital, Lille

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kamel LARIBI, Dr

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Chd Le Mans

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles HERBAUX, Dr

Role: CONTACT

3 20 44 57 13 ext. +33

Alexandra FAYAULT

Role: CONTACT

Facility Contacts

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Kamel LARIBI, MD

Role: primary

+33243434361

Other Identifiers

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T-PLL

Identifier Type: -

Identifier Source: org_study_id

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