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Trial record 1 of 1 for:    NCT 04411043
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Observatory of Prolymphocytic Leukemia T (T-PLL)

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ClinicalTrials.gov Identifier: NCT04411043
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : July 27, 2022
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Study Description
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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.

Condition or disease Intervention/treatment
Prolymphocytic Leukemia T-cell Leukemia Behavioral: Molecular caracterization

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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

Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
bone marrow and peripheral blood cells

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with prolymphocytic T leukemia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Absence of signature of informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411043


Contacts
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Contact: Charles HERBAUX, Dr 3 20 44 57 13 ext +33 Charles.herbaux@chru-lille.fr
Contact: Alexandra FAYAULT a.fayault@filo-leucemie.org

Locations
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France
Chd Le Mans Recruiting
Le Mans, France, 72000
Contact: Kamel LARIBI, MD    +33243434361    klaribi@ch-lemans.fr   
Sponsors and Collaborators
French Innovative Leukemia Organisation
University Hospital, Lille
Investigators
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Principal Investigator: Kamel LARIBI, Dr French Innovative Leukemia Organisation
More Information
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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT04411043    
Other Study ID Numbers: T-PLL
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, T-Cell
Leukemia, Prolymphocytic
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
 Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases