Novel Therapeutic Approach for Human T-cell Malignancies

NCT06600568 | Recruiting

• 1 other identifier: ROSinTALL
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Secondary outcome

  Through study completion, an average of 2 years

• Secondary outcome

  Through study completion, an average of 2 years

• Secondary outcome

  Through study completion, an average of 2 years

Interventions

Translation analysis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to a maximum of 120 patients (both retrospective and prospective) are expected to be enrolled during the study period. Specifically, a maximum of 40 patients will be enrolled for each of the following diseases: T-cell lymphoblastic leukemias (T-ALL); T-cell non-Hodgkin lymphomas (T-NHL); NK-cell neoplasms. For retrospective peripheral blood samples, bone marrow aspirates, and lymph node biopsies, which are available at the centers involved in the study, patients will be contacted again to ask for consent regarding this project. No additional clinical procedures are specifically required by participation in the present study. In fact, samples will be obtained from the material left over from samples taken for clinical procedures.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale: collaborator
• Istituto Oncologico Veneto IRCCS: lead

Study Sites (2)

Istituto Nazionale Tumori Fondazione G.Pascale

Naples, 80100, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Michele Gottardi, MD

CONTACT

+39 0423732336; michele.gottardi@iov.veneto.it

GianLuca De Salvo, MD

CONTACT

+390498215704; gianluca.desalvo@iov.veneto.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)