Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention

Not Applicable

Recruiting

• Conditions: Myeloid Leukemia, Acute; Leukemia, Acute Lymphoblastic
• Interventions: Biological: Functional tests; Genetic: Next Generation Sequencing analysis; Biological: Microvesicles analysis

• Registration Number: NCT06626893
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief Summary

The goal of this clinical trial is to use multiple "omics" sciences to more thoroughly investigate Acute Recurrent/Refractory Leukemias (LA R/R) after conventional therapy in order to identify new targets and/or therapeutic approaches, in patients with a diagnosis of Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma B(ALL-B), Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma T (ALL-T), Acute Biphenotypic Leukemia/II as defined by WHO( World Health Organization) 2016, relapsed or refractory after at least one line of therapy. The main question that the trial aims to answer is: "Can molecules with known biological activity be active and represent possible new therapeutic strategies in relapsed/refractory Acute Leukemias on the basis of response profiles identified through the integration of next-generation chemogenomic and functional analyses? " It is expected that a minimum of 100 patients, male and female, aged 18 years and older, will be included. To participate in the study, the patient must consent to the performance on biological specimen (peripheral blood and bone marrow) of genetic/molecular and/or "omics" investigations performed with modern sequencing techniques, such as Next Generation Sequencing, Single Cell RNA Seq (scRNAseq), RT-qPCR(Quantitative reverse transcription polymerase chain reaction). These investigations will aim to improve the understanding of the genetic and molecular alterations of her disease. In addition, your cells will be used in the laboratory to perform in vitro sensitivity studies (drug response profiling - DRP) that aim to simultaneously test a set of hundreds of drugs to assess sensitivity or resistance profiles of your disease cells with the aim of identifying specific new therapies that target specific cellular mechanisms. In addition, part of the biological sample will be used for investigations of the bone marrow microenvironment and the "secretome", i.e., cell signaling molecules and methods. In order to accomplish this study, samples from peripheral or bone marrow blood taken during routine investigations performed during follow-up and re-evaluation visits for the patient's disease as per normal clinical practice will be used. Among the investigations that will be performed on the blood sample will be the genetic/molecular and/or omics and preclinical investigations described above.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2024-03-21
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients to be enrolled in the study must have a diagnosis of AML, B ALL/LBL, T ALL/LBL, MPAL/AUL as described by WHO 2016 classification and must complained relapsed or refractory disease after at least one line of therapy
• Ages Eligible for Study: over 18years
• Patients must have greater than 5% blasts in the bone marrow with or without extramedullary disease
• Patients with must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis
• Patients may be enrolled on study regardless of the timing of prior I therapy
• Patients must be capable of understanding the investigational nature and the objectives of the study. All patients must sign a written informed consent.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relapsed Refractory Acute Leukemias	Functional tests	Functional and genomics analyses will be performed on primary sample from each enrolled patient (biological preclinical study)
Relapsed Refractory Acute Leukemias	Next Generation Sequencing analysis	Functional and genomics analyses will be performed on primary sample from each enrolled patient (biological preclinical study)
Relapsed Refractory Acute Leukemias	Microvesicles analysis	Functional and genomics analyses will be performed on primary sample from each enrolled patient (biological preclinical study)

Primary Outcome Measures

Name	Time	Method
Frequencies of alternative therapies identified for AL patients	12 months	Number of patients treated with alternative therapies

Trial Locations

Locations (8)

IRST-IRCCS Meldola; 🇮🇹 Meldola, Forlì-Cesena, Italy

A.O.U. Bologna; 🇮🇹 Bologna, Italy

A.O.U. Ferrara; 🇮🇹 Ferrara, Italy

AOU Parma; 🇮🇹 Parma, Italy

Piacenza Hospital - AUSL Piacenza; 🇮🇹 Piacenza, Italy

Ravenna Hospital - AUSL Romagna; 🇮🇹 Ravenna, Italy

A.O. Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Rimini Hospital-AUSL Romagna; 🇮🇹 Rimini, Italy