Actively Recruiting
Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2024-10-04
100
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML, B ALL/LBL, T ALL/LBL, or MPAL/AUL per WHO 2016 classification with relapsed or refractory disease after at least one line of therapy
- Age 18 years or older
- More than 5% blast cells in the bone marrow with or without disease outside the bone marrow
- Recurrent disease confirmed by clinical or radiographic criteria and histologic verification at original diagnosis
- Enrollment allowed regardless of timing of prior therapy
- Ability to understand study objectives and provide written informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
IRST-IRCCS Meldola
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
2
A.O.U. Bologna
Bologna, Italy, 40138
Actively Recruiting
3
A.O.U. Ferrara
Ferrara, Italy, 44124
Actively Recruiting
4
AOU Parma
Parma, Italy, 43126
Actively Recruiting
5
Piacenza Hospital - AUSL Piacenza
Piacenza, Italy, 29121
Actively Recruiting
6
Ravenna Hospital - AUSL Romagna
Ravenna, Italy, 48121
Actively Recruiting
7
A.O. Reggio Emilia
Reggio Emilia, Italy, 42100
Actively Recruiting
8
Rimini Hospital-AUSL Romagna
Rimini, Italy, 47923
Actively Recruiting
Research Team
B
Benedetta Cambò, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here