Novel Therapeutic Approach for Human T-cell Malignancies

Recruiting

• Conditions: T-Cell Leukemia/Lymphoma, Adult

• Registration Number: NCT06600568
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

Brief Summary

This multicenter translational study, with prospective and retrospective samples, aims to identify new strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.

Interactions between drugs capable of activating the apoptotic process (e.g., Venetoclax) and drugs capable of altering ROS homeostasis (e.g., inhibitors of the enzyme glucose-6-phosphate dehydrogenase) will be examined.

The most promising compounds will be selected based on results obtained in vitro on cell lines and PDX already available in the laboratory, and then will be assayed ex vivo in cells obtained from patients with resistant/refractory T-cell neoplasms.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with pre- and post-thymic T-cell leukemia/lymphoma
• Patients of both sexes
• Age of patients older than 18 years
• Patient is willing to provide written and signed informed consent for participation in the study

Exclusion Criteria

-Serious illness or medical condition that does not allow the patient to be managed according to standard treatment protocols, including uncontrolled active infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome	Through study completion, an average of 2 years	Response of leukemic cells to treatments that remodulate redox state and apoptosis from a molecular point of view, ex vivo,through the development of a multidimensional approach aimed at reducing the chemoresistance of T neoplasms

Secondary Outcome Measures

Name	Time	Method
Secondary outcome	Through study completion, an average of 2 years	Analysis of the efficacy of new drug combinations in vivo through the generation of PDX-based experimental mouse models derived from patients with T-cell malignancies.

Trial Locations

Locations (2)

Istituto Nazionale Tumori Fondazione G.Pascale; 🇮🇹 Napoli, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy