Observatory of Prolymphocytic Leukemia T
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Molecular caracterization.
- Who it may be relevant to
- Registry conditions: Prolymphocytic Leukemia, T-cell Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.
Overview
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.
Interventions
- Behavioral Molecular caracterization
Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T
Primary outcome measures
- Clinical characteristics of prolymphocytic leukemia T [Time frame: from day 0 through study completion, an average of 3 years]
- Biological characteristics of prolymphocytic leukemia T [Time frame: At day 0 and at relapse, an average of 3 years]
- Flow cytometry data of bone marrow and blood cells [Time frame: At day 0 and at relapse, an average of 3 years]
- karyotype of tumor cells [Time frame: At day 0 and at relapse, an average of 3 years]
Eligibility criteria
Inclusion criteria
- Man or woman aged 18 or over
- Patient with prolymphocytic T leukemia
Exclusion criteria
- Absence of signature of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chd Le Mans — Le Mans
Identifiers
NCT: NCT04411043 · T-PLL