An interventional study of Functional tests and Next Generation Sequencing analysis in Myeloid Leukemia, Acute and Leukemia, Acute Lymphoblastic, sponsored by Azienda Ospedaliero-Universitaria di Parma. Recruiting at 8 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Not applicable, Interventional, and Basic science
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Azienda Ospedaliero-Universitaria di Parma is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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Functional and genomics analyses will be performed on primary sample from each enrolled patient (biological preclinical study)
Biological: Functional tests · Genetic: Next Generation Sequencing analysis · Biological: Microvesicles analysis
Functional analyses will be performed on primary sample from each enrolled patient. Isolated blast cells are cultered and incubated with a specific library of drugs (175 drugs) at four different concentrations for 72 hours.
For each patient, sequencing analyses will be performed on blast cells (for somatic mutations) and on epithelial cells from buccal swab (for germline mutations)
Analyses on microvesicles isolated from both Bone Marrow samples and Peripheral Blood Samples will be performed to investigate the microenvironment of the disease.
Frequencies of alternative therapies identified for AL patients
Number of patients treated with alternative therapies
Time frame: 12 months
Functional and chemogenomic profiling
Dose-response curves for each drug tested, genetic profile for NGS analyses, description of vesicles contents
Time frame: 24 months
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Azienda Ospedaliero-Universitaria di Parma