Clinical trial NCT06626893: Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Official title: Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myeloid Leukemia, Acute
Leukemia, Acute Lymphoblastic
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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:

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Primary outcomes:
measure: Frequencies of alternative therapies identified for AL patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Functional and chemogenomic profiling
timeFrame: 24 months
Locations:
city: Meldola
country: Italy
facility: IRST-IRCCS Meldola
state: Forlì-Cesena
city: Bologna
country: Italy
facility: A.O.U. Bologna
city: Ferrara
country: Italy
facility: A.O.U. Ferrara
city: Parma
country: Italy
facility: AOU Parma
city: Piacenza
country: Italy
facility: Piacenza Hospital - AUSL Piacenza
city: Ravenna
country: Italy
facility: Ravenna Hospital - AUSL Romagna
city: Reggio Emilia
country: Italy
facility: A.O. Reggio Emilia
city: Rimini
country: Italy
facility: Rimini Hospital-AUSL Romagna
Study officials:
References: