Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04411043
Status:
RECRUITING
Last Update Posted:
2022-07-27
First Post:
2020-05-13
Brief Title:
Observatory of Prolymphocytic Leukemia T
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
Prospective and Retrospective Study Evaluating Epidemiological Clinical Molecular and Therapeutic Data of Prolymphocytic Leukemia T
Status:
RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T-PLL
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None