Actively Recruiting
Molecular Study of Adult Triple Negative B-cell Acute Lymphoblastic Leukemia Characterizing Subtypes and Identifying New Treatment Targets
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-04-09
60
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate adult patients with triple negative B-cell Acute Lymphoblastic Leukemia B-ALL who do not have the most common genetic rearrangements linked to the disease. These patients often have a poor prognosis and lack targeted therapies. The study focuses on understanding the molecular characteristics of this subgroup, especially regarding CRLF2 gene alterations, which are important in both adult and pediatric cases and may influence treatment outcomes. The study is non-interventional and observational, meaning treatment decisions are made by doctors as usual and are not influenced by participation. Patients diagnosed with primary or secondary B-ALL will be enrolled and their blood, bone marrow, and saliva samples collected for detailed biological analysis using various laboratory techniques, including gene sequencing and flow cytometry. Both prospective and retrospective patient groups will be studied over a planned period of 36 months. Participants will provide biological samples and clinical data, which will be recorded in a dedicated database. Researchers will evaluate molecular markers to identify patient subgroups, assess potential biomarkers, and correlate findings with survival outcomes. The study aims to develop a rapid and cost-effective method for identifying these leukemia subtypes, with ongoing monitoring and data collection continuing throughout the three-year study duration.
CONDITIONS
Brief Title
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent for participation in the study
- Patients with new diagnosis and/or relapse/s of primary or secondary B-cell Acute Lymphoblastic Leukemia (B-ALL)
- Negative for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements
- Male or Female, aged over 18 years
- Availability of clinical data
You will not qualify if you...
- Age under 18 years
- B-ALL positive for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements
- Low blast percentage (less than 70%) samples may be excluded for molecular evaluations, but not for cytofluorimetric analyses
Research Team
O
Oriana Nanni, Dr
A
Anna Ferrari, Dr
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