RecruitingNCT06919393

"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL

"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

60 participants

Start Date

Oct 23, 2019

Study Type

OBSERVATIONAL

Conditions

Leukemia, Lymphoblastic

Summary

It is a multicenter, non-interventional, non pharmacological, translational, prospective study. Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data on a rare type of blood cancer called B-cell Acute Lymphoblastic Leukemia (B-ALL) that is "triple negative" — meaning it lacks three specific genetic abnormalities that doctors usually look for. Researchers want to better understand this subtype and how it responds to treatment. **You may be eligible if...** - You are 18 years or older - You have a new or relapsed diagnosis of B-ALL - Your cancer tests negative for three specific chromosomal rearrangements (BCR-ABL1, TCF3-PBX1, MLL-AF4) - Your clinical data is available for review **You may NOT be eligible if...** - You are under 18 years old - Your B-ALL tests positive for any of the three specific chromosomal rearrangements listed above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER"Triple negative" adul B-cell ALL

Samples will be studied with conventional techniques to classify and define properly the disease: morphology, immunophenotype, immunohistochemistry (IHC), conventional Cytogenetic Fluorescence in Situ Hybridization (FISH) will be used when appropriate. ● Isolation of Mononuclear cells The following research methodologies will be applied: * Next Generation Sequencing * Flow cytometry analysis of 3C-up B-ALL top three markers * Gene expression profile analysis * Copy number Alterations analysis * In vitro studies

Locations(3)

Irst Irccs

Meldola, FC, Italy

Ospedale S. Maria delle Croci RAVENNA

Ravenna, RA, Italy

Ospedale Infermi

Rimini, RN, Italy

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NCT06919393

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