Clinical trial Recruiting at 3 sites Observational Ages 18 and up

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.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Academic / other
Locations3 sites (Meldola, FC and 2 other locations)
StatusRecruiting
StartedOctober 23, 2019
Main results expectedJanuary 2026
Study endsJanuary 2026
Registry record updatedApril 9, 2025
Trial IDNCT06919393 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.