Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06626893

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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