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Novel Therapeutic Approach for Human T-cell Malignancies

Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a Novel Therapeutic Approach for Human T-cell Malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06600568
Enrollment
120
Registered
2024-09-19
Start date
2025-03-18
Completion date
2027-03-01
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T-Cell Leukemia/Lymphoma, Adult

Keywords

T-cell lymphoblastic leukemias (T-ALL), T-cell non-Hodgkin's lymphomas (T-NHL), NK cell neoplasia, ROS, apoptosis

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.

Interventions

Novel strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.

Sponsors

Istituto Oncologico Veneto IRCCS
Lead SponsorOTHER
Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary outcomeThrough study completion, an average of 2 yearsResponse 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

MeasureTime frameDescription
Secondary outcomeThrough study completion, an average of 2 yearsDevelopment of drug combinations that can selectively eliminate T-cell leukemia/lymphoma cells

Countries

Italy

Contacts

CONTACTMichele Gottardi, MD
michele.gottardi@iov.veneto.it+39 0423732336
CONTACTGianLuca De Salvo, MD
gianluca.desalvo@iov.veneto.it+390498215704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026