Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971305
Status:
RECRUITING
Last Update Posted:
2022-05-09
First Post:
2019-05-30
Brief Title:
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK ALCL
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2022-05
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:
With the development of molecular biology and precise medical treatment new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma NHL in children In recent years the criteria for clinical staging and efficacy evaluation of NHL in children have been updated Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma ALCL in children and adolescents minimal disseminated disease MDD in peripheral blood or bone marrow and minimal residual disease MRD are significantly associated with prognosis suggesting that these factors need to be combined in risk stratification of ALCL patients Recent studies have also suggested that PETCT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy In order to keep pace with the times in the diagnosis clinical staging risk stratification efficacy evaluation and treatment of NHL in children We adjusted the original NHL-BFM-9095 regimen mainly in the aspects of clinical staging efficacy evaluation risk stratification and treatment regimenetc
Detailed Description:
Research purpose
1 To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma
2 To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival
3 To explore the feasibility of risk stratification combined with adverse pathological types dangerous organ invasion and MDD
4 To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment
1 To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma
2 To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival
3 To explore the feasibility of risk stratification combined with adverse pathological types dangerous organ invasion and MDD
4 To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment
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