Actively Recruiting
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants who undergo routine care are observed. Blood, bone marrow, and saliva samples are collected according to clinical practice for research purposes including molecular and genetic analyses.
Visits and sample collections occur as part of routine clinical care over the study period
Trial Site Locations
Total: 3 locations
1
Irst Irccs
Meldola, FC, Italy, 47014
Actively Recruiting
2
Ospedale S. Maria delle Croci RAVENNA
Ravenna, RA, Italy, 48121
Actively Recruiting
3
Ospedale Infermi
Rimini, RN, Italy, 47923
Actively Recruiting
Research Team
O
Oriana Nanni, Dr
A
Anna Ferrari, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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