Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03603847
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2018-07-18
Brief Title:
Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
The Lymphoma Academic Research Organisation
Study Overview
Official Title:
Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-09
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:
None
Brief Summary:
The study aims to evaluate the prognostic value on the complete metabolic response rate MCR the incidence of relapse progression the Progression Free Survival PFS and the Overall Survival OS
at diagnosis
after the first cycle of CHOEP early evaluation
at the end of treatment
at diagnosis
after the first cycle of CHOEP early evaluation
at the end of treatment
Detailed Description:
ALK-positive anaplastic large cell anaplastic large-cell lymphoma ALCL is a rare adult disease for which almost all published studies are retrospective The overall survival OS at 5 years varies from 70 to 87 A recent international pooled analysis showed that the International Prognostic Index IPI had good predictive value for the PFS and the OS
In children new prognostic factors have been identified the titre of circulating anti-ALK antibodies inverse correlation between the antibody titre and the prognosis the detection of a NPM-ALK transcript in the blood at diagnosis minimal disseminated disease MDD correlation between MDD positivity and pejorative prognosis and its minimal residual disease MRD and the histological subtype common versus small cells lymphohistiocytic
The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study
At diagnosis before starting treatment
Cycle 2 Day 1 before starting cycle 2 treatment
At the end of treatment evaluation
40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively
During a 2-year period relapses progressions and patient deaths will be monitored for the calculation of the incidence of relapse progression progression free survival PFS and overall survival OS
In children new prognostic factors have been identified the titre of circulating anti-ALK antibodies inverse correlation between the antibody titre and the prognosis the detection of a NPM-ALK transcript in the blood at diagnosis minimal disseminated disease MDD correlation between MDD positivity and pejorative prognosis and its minimal residual disease MRD and the histological subtype common versus small cells lymphohistiocytic
The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study
At diagnosis before starting treatment
Cycle 2 Day 1 before starting cycle 2 treatment
At the end of treatment evaluation
40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively
During a 2-year period relapses progressions and patient deaths will be monitored for the calculation of the incidence of relapse progression progression free survival PFS and overall survival OS
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