Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626893
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-21
Brief Title:
Integrative Omics Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrative Omics Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AL-TOMICA
Brief Summary:
The goal of this clinical trial is to use multiple omics sciences to more thoroughly investigate Acute RecurrentRefractory Leukemias LA RR after conventional therapy in order to identify new targets andor therapeutic approaches in patients with a diagnosis of Acute Myeloid Leukemia AML Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma BALL-B Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma T ALL-T Acute Biphenotypic LeukemiaII 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 relapsedrefractory 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 geneticmolecular andor omics investigations performed with modern sequencing techniques such as Next Generation Sequencing Single Cell RNA Seq scRNAseq RT-qPCRQuantitative 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 ie 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 patients disease as per normal clinical practice will be used Among the investigations that will be performed on the blood sample will be the geneticmolecular andor omics and preclinical investigations described above
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None