Clinical trial · Observational
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL
"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification
NCT06919393CI-TRIAL-00088350TRINEG-ALLrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphoblastic | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Triple negative" adul B-cell ALL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- "Triple negative" adul B-cell ALL
- description
- Prospective and retrospective cohorts.
- interventionNames
- Other: "Triple negative" adul B-cell ALL
Primary outcomes (1)
- measure
- Biological characterization for B-ALL Ph-/-/- subgroup identification
- timeFrame
- 3 years
- description
- Biological characterization of Ph-/-/- ALL, considering CRLF2 overexpression event, to better define clusters preliminarily identified and to identify biomarkers in these subgroups. Each sample at diagnosis and/or relapse time-point will be sequenced with an RNA-seq capture approach. Through bioinformatic analysis we will identify upregulated CRLF2 samples and associated gene signature. Fusion, mutation identification will integrate expression data.
Secondary outcomes (3)
- measure
- Correlation, in terms of survival, between identified Ph-/-/- molecular subgroups and eventual novel associated molecular features.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.