Observatory of Prolymphocytic Leukemia T

Prolymphocytic Leukemia Clinical Trial

— T-PLL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411043
• Other study ID #: T-PLL
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2022
• Source: French Innovative Leukemia Organisation
• Contact: Charles HERBAUX, Dr
• Phone: 3 20 44 57 13
• Email: Charles.herbaux[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man or woman aged 18 or over

• Patient with prolymphocytic T leukemia

Exclusion Criteria:

• Absence of signature of informed consent

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Prolymphocytic
• Leukemia, T-Cell
• Prolymphocytic Leukemia
• T-cell Leukemia

Intervention

Behavioral:
• Molecular caracterization
Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T

Locations

Country	Name	City	State
France	Chd Le Mans	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Flow cytometry data of bone marrow and blood cells	Positive or negative immunophenotyping	At day 0 and at relapse, an average of 3 years
Primary	karyotype of tumor cells	karyotipic formula	At day 0 and at relapse, an average of 3 years