Observational study on triple negative adult B-cell acute lymphoblastic leukemia
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| 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) |
| Trial ID | NCT06919393 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Meldola, FC and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.