Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06626893

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Functional and Genomic Analysis

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

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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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