Studies adults with triple negative B-cell acute lymphoblastic leukemia
Observes adults with triple negative B-cell acute lymphoblastic leukemia, studying their disease features.
Key facts
- Who runs it
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Where
- Meldola, Ravenna, and Rimini, ItalySee the 3 sites
- Trial code
- Registry title
- "Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 23 Oct 2019
- Planned end
- Jan 2026
- Type of study
- Observational
- Treatments tested
- "Triple negative" adul B-cell ALL
- Record updated
- 9 April 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed or relapsed B-cell acute lymphoblastic leukemia (B-ALL) that is negative for three specific gene rearrangements. It is an observational study; treatment is decided by the doctor.
- Age
- Older than 18 years
- Sex
- Women and men can join
- Disease stage
- New diagnosis and/or relapse of primary or secondary B-ALL
- Biomarker or test result
- Negative for BCR-ABL1 t(9;22), TCF3-PBX1 t(1;19) and MLL-AF4 t(4;11) rearrangements
Main reasons for not taking part
- Younger than 18 years
- B-ALL positive for BCR-ABL1 t(9;22), TCF3-PBX1 t(1;19) or MLL-AF4 t(4;11) rearrangements
- Samples with a low blast percentage (<70%) could be left out of the molecular tests
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Italy
- Irst-IrccsMeldola, ItalyContact: Anna Ferrari, DrTaking people
- Ospedale S. Maria delle Croci RAVENNARavenna, ItalyContact: Oriana Nanni, DrTaking people
- Ospedale "Infermi"Rimini, ItalyContact: Oriana Nanni, DrTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- "Triple negative" adul B-cell ALL
Prospective and retrospective cohorts.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- "Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
- Plain-language title
- Studies adults with triple negative B-cell acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 April 2025