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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating Acute Recurrent/Refractory Leukemias, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma B and T types, and Acute Biphenotypic Leukemia as defined by WHO 2016. The study aims to identify new treatment targets and potential therapies for patients whose disease has returned or not responded after at least one prior therapy. The main focus is on understanding disease mechanisms using combined "omics" technologies and functional analyses to find molecules that may offer new treatment options. The study involves molecular and genetic testing of patients' blood and bone marrow samples using advanced sequencing methods like Next Generation Sequencing, Single Cell RNA sequencing, and quantitative PCR. In vitro drug sensitivity tests will be performed on isolated disease cells to assess responses to a wide range of drugs. Additional analyses will examine the bone marrow microenvironment and cell signaling molecules. Samples are collected during routine clinical care visits. Participants will provide biological samples such as peripheral blood and bone marrow, which will undergo various genetic, molecular, and functional tests. Researchers will monitor the frequency of alternative therapies identified over 12 months. The study includes ongoing evaluation of the disease through routine clinical visits and sample collections. Participants must consent to these tests and understand the study's goals. The research will improve knowledge of leukemia biology and may guide future treatment strategies.
CONDITIONS
Brief 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 as defined by WHO 2016 classification
- Relapsed or refractory disease after at least one line of therapy
- Age 18 years or older
- Greater than 5% blasts in bone marrow, with or without extramedullary disease
- Recurrent disease documented by clinical or radiographic criteria and histologic verification at original diagnosis
- Patients may be enrolled regardless of timing of prior therapy
- Ability to understand the investigational nature and objectives of the study
- Signed 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment period
Participants provide primary samples for functional testing and next generation sequencing analyses to identify potential therapeutic targets.
1 visit for sample collection (in-person)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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