Observational study on triple negative adult B-cell acute lymphoblastic leukemia
Official title: "Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
Run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT06919393 · Data updated 2026-11-12
This study looks at adults with triple negative B-cell acute lymphoblastic leukemia to see how genetic changes might affect their treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Locations | 3 sites (Meldola, FC and 2 other locations) |
| Status | Recruiting |
| Started | October 23, 2019 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | April 9, 2025 |
| Trial ID | NCT06919393 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a new diagnosis or relapse of primary or secondary B-ALL who are negative for specific genetic rearrangements.
✕Probably not a fit
Patients under 18 years old or those with B-ALL positive for the specified genetic rearrangements will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, non-interventional study focuses on adult patients diagnosed with triple negative B-cell acute lymphoblastic leukemia (B-ALL). It aims to improve the understanding of this leukemia subtype by analyzing genetic alterations that may predict treatment outcomes. Physicians will make treatment decisions based on their clinical judgment, independent of the study participation. The study seeks to gather clinical data to enhance the molecular characterization of triple negative B-ALL and identify potential targeted therapies.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with triple negative B-ALL.
How similar studies have gone: While there has been significant progress in treating other subtypes of B-ALL, the specific approach for triple negative B-ALL is less explored, making this study a novel endeavor.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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-ALL; * Negative for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements; * Participant is willing and able to give informed consent for participation in the study; * Male or Female, aged \>18 years; * Availability of clinical data. Exclusion Criteria: * Age \< 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 (\<70%) samples could be excluded for molecular evaluations, not for cytofluorimetric analyses;
Where it's running
-
Irst Irccs
Meldola, Fc, Italy Recruiting -
Ospedale S. Maria delle Croci RAVENNA
Ravenna, Ra, Italy Recruiting -
Ospedale Infermi
Rimini, Rn, Italy Recruiting
Study contacts
- Study coordinator: Oriana Nanni, Dr
- Email: oriana.nanni@irst.emr.it
- Phone: +39 0543739100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.