Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04582487|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|T Acute Lymphoblastic Leukemia Early T Acute Lymphoblastic Leukemia T-lymphoblastic Lymphoma Etp All||Other: bone marrow and/or peripheral blood samples withdrawal||Not Applicable|
This is a biological study for R/R T-ALL/LBL or ETP-ALL patients. Bone marrow and/or peripheral blood samples will be subjected to genomic, DSRP profiling and phosphoproteomic screening to identify novel potential therapeutic approach and thus, eligibility for treatment based on molecular and DSRP data.
Genomic studies include karyotyping, CI-FISH and sequencing of 72 selected genes recurrently involved in T-ALL (by NGS).
A panel of 80 compounds has been choosen for DSRP profile.
As soon as genomic and DSRP profiling are made available, local Investigator can submit to local ethic committee a request for clinical use of compound hits. Meanwhile, in case of leukocytosis and uncontrolled disease, patients will be treated with cytoreductive therapies and best supportive care according to guidelines and scientific consensus.
Every patient will receive a molecularly and functionally informed therapy following the therapeutic schedule already defined by in other tumors. Treatment will be selected on the basis of integration of genomic and small response data.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
A combined approach of Drug Sensitivity and Resistance Profiling (DSRP) and molecular-cytogenetic findings is used in order to prioritize compounds for tailored therapies.
Other: bone marrow and/or peripheral blood samples withdrawal
bone marrow and/or peripheral blood samples evaluation
- Drug sensitivity profile [ Time Frame: baseline ]Frequencies of alternative therapies identified for T-ALL patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582487
|Contact: Paola Fazifirstname.lastname@example.org|
|Contact: Enrico Creaemail@example.com|
|Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia||Recruiting|
|Contact: Renato Bassan Renato.Bassan@aulss3.veneto.it|
|Ematologia ed Immunologia Clinica||Recruiting|
|Contact: Cristina Mecucci firstname.lastname@example.org|
|Contact: Roberta La Starza|