Trial Title:
Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
NCT ID:
NCT06626893
Condition:
Myeloid Leukemia, Acute
Leukemia, Acute Lymphoblastic
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Acute Disease
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Functional tests
Description:
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.
Arm group label:
Relapsed Refractory Acute Leukemias
Intervention type:
Genetic
Intervention name:
Next Generation Sequencing analysis
Description:
For each patient, sequencing analyses will be performed on blast cells (for somatic
mutations) and on epithelial cells from buccal swab (for germline mutations)
Arm group label:
Relapsed Refractory Acute Leukemias
Intervention type:
Biological
Intervention name:
Microvesicles analysis
Description:
Analyses on microvesicles isolated from both Bone Marrow samples and Peripheral Blood
Samples will be performed to investigate the microenvironment of the disease.
Arm group label:
Relapsed Refractory Acute Leukemias
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients to be enrolled in the study must have a diagnosis of AML, B ALL/LBL, T
ALL/LBL, MPAL/AUL as described by WHO 2016 classification and must complained
relapsed or refractory disease after at least one line of therapy
- Ages Eligible for Study: over 18years
- Patients must have greater than 5% blasts in the bone marrow with or without
extramedullary disease
- Patients with must have recurrent disease, documented by clinical or radiographic
criteria, as well as histologic verification of the malignancy at original diagnosis
- Patients may be enrolled on study regardless of the timing of prior I therapy
- Patients must be capable of understanding the investigational nature and the
objectives of the study. All patients must sign a written informed consent.
Exclusion Criteria:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRST-IRCCS Meldola
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Martinelli, MD
Phone:
0543 1931094
Facility:
Name:
A.O.U. Bologna
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Curti, MD
Phone:
051 2143680
Facility:
Name:
A.O.U. Ferrara
Address:
City:
Ferrara
Zip:
44124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Antonio Cuneo, MD
Phone:
0532 236978
Facility:
Name:
AOU Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Benedetta Cambò, PHD
Phone:
0521 704446
Email:
bcambo@ao.pr.it
Facility:
Name:
Piacenza Hospital - AUSL Piacenza
Address:
City:
Piacenza
Zip:
29121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniele Vallisa, MD
Phone:
0523 302242
Facility:
Name:
Ravenna Hospital - AUSL Romagna
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Lanza, MD
Phone:
0833 773899
Facility:
Name:
A.O. Reggio Emilia
Address:
City:
Reggio Emilia
Zip:
42100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessia Tieghi, MD
Phone:
0522 296673
Facility:
Name:
Rimini Hospital-AUSL Romagna
Address:
City:
Rimini
Zip:
47923
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizia Tosi, MD
Phone:
0541 705111
Start date:
March 1, 2022
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Azienda Ospedaliero-Universitaria di Parma
Agency class:
Other
Source:
Azienda Ospedaliero-Universitaria di Parma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06626893
