Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959720
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-07-17
Brief Title:
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Instituto do Cancer do Estado de São Paulo
Study Overview
Official Title:
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
Status:
RECRUITING
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:
BRALLA
Brief Summary:
In this project the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers provided that all patients will be treated with the same regimen a pediatric regimen BFM-based incorporating peg-asparaginase All diagnosticfollow-up after induction and consolidation blocks samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival EFS and overall survival OS of newly diagnosed patients in the participating centers
Detailed Description:
Notably pediatric regimens for adult acute lymphoblastic leukemia ALL have resulted in better long-term outcomes especially in the Philadelphia-negative counterpart These regimens are essentially based on higher cumulative doses of asparaginase and the use of less myelotoxic agents applying allogeneic transplantation only for high-risk ALL subsets Recent metanalysis encompassing 27 clinical trials demonstrated an improved prognosis when these regimens are adopted In adults incorporation of these regimens has been hampered by a perception of higher toxicity and a more complex design especially with asparaginase Remarkably this drug might bring side effects not usually seen with other cancer drugs such as thrombosis liver and pancreatic toxicities In addition the incorporation of minimal residual disease MRD monitoring throughout the treatment protocol in a scheduled and standardized manner is considered paramount in the contemporary ALL treatment Treating adult patients with acute leukemia under prospective studies allows accurate data collection and positively impacts the disease prognosis creating a cooperative scientific environment In Brazil few data are available on the clinical- laboratory characteristics of ALL in adults and their outcomes under a standardized treatment protocol Few single-center reports point to a worse overall survival rate when compared to developed countries There is great heterogeneity across the centers regarding the treatment regimens and geneticMRD assessment In this project the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers provided that all patients will be treated with the same regimen a pediatric regimen BFM-based incorporating peg-asparaginase All diagnosticfollow-up after induction and consolidation blocks samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo At the diagnosis a genetic characterization encompassing conventional karyotype fluorescent in-situ hybridization FISH and molecular biology in our central laboratory will be performed to classify the cases Genomic classification will include identifying Philadelphia- like B-cell ALL cases a recent group of cases with worse prognosis whose incidence seems higher in Hispanics In Brazil there is no study addressing this incidence and more importantly evaluating its impact on outcomes under a standardized treatment protocol MRD analysis will also be centralized to standardize and validate our flow cytometry panel in a homogeneous cohort Additionally the investigators plan to assess baseline factors predictive of survival and relapse and those related to major toxicities such as infections liver toxicity and thrombosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None