"Triple Negative" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL

NCT06919393 | Recruiting

• 1 other identifier: IRSTB098
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Leukemia, Lymphoblastic

Keywords

lymphoblastic acute leukemia (LAL); triple negative; B cell

Outcome Measures

Primary Outcomes (1)

• Biological characterization for B-ALL Ph-/-/- subgroup identification

  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.

  3 years

Secondary Outcomes (3)

• Correlation, in terms of survival, between identified Ph-/-/- molecular subgroups and eventual novel associated molecular features.

  3 years

• Cytofluorimetric evaluation of Ph-/-/- ALL markers as CRLF2, CTGF and CD200.

  3 years

• Discover new biomarkers identified Ph-/-/- molecular subgroups

  3 years

Study Arms (1)

"Triple negative" adul B-cell ALL

Prospective and retrospective cohorts.

Other: "Triple negative" adul B-cell ALL

Interventions

"Triple negative" adul B-cell ALL OTHER

Samples will be studied with conventional techniques to classify and define properly the disease: morphology, immunophenotype, immunohistochemistry (IHC), conventional Cytogenetic Fluorescence in Situ Hybridization (FISH) will be used when appropriate. ● Isolation of Mononuclear cells The following research methodologies will be applied: * Next Generation Sequencing * Flow cytometry analysis of 3C-up B-ALL top three markers * Gene expression profile analysis * Copy number Alterations analysis * In vitro studies

"Triple negative" adul B-cell ALL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Ph-/-/- B cell Acute Lymphoblastic Leukemia (see inclusion criteria) will be considered for enrolment. Therefore, patients can be enrolled at diagnosis or relapse/s. About 60 patients affected by primary or secondary B-ALL, at diagnosis and/or relapse/s will be enrolled in this study. All suitable prospective fresh PB and/or BM samples will be evaluated with cytofluorimetric panel.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (3)

Irst Irccs

Meldola, FC, 47014, Italy

RECRUITING

Ospedale S. Maria delle Croci RAVENNA

Ravenna, RA, 48121, Italy

RECRUITING

Ospedale Infermi

Rimini, RN, 47923, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh peripheral blood and bone marrow samples will be collected before treatment and/or at relapse. Saliva sample will be collected for each enrolled patient. Whenever possible, saliva sample should be collected during treatment, in order to reduce tumor contamination; if not feasible, saliva sample can be collected at patient enrollment.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Giovanni Martinelli, Prof

  IRST IRCCS

  STUDY DIRECTOR

Central Study Contacts

Oriana Nanni, Dr

CONTACT

+39 0543739100; oriana.nanni@irst.emr.it

Anna Ferrari, Dr

CONTACT

0543739909; anna.ferrari@irst.emr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: April 9, 2025
• Study Start: October 23, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)