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NCT Number: NCT06600568

Novel Therapeutic Approach for Human T-cell Malignancies

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Nazionale Tumori Fondazione G.Pascale, Naples, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Translation analysis

Other

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

Primary outcomes

  1. Primary outcome

    Time frame: 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 outcomes

  1. Secondary outcome

    Time frame: Through study completion, an average of 2 years

    Development of drug combinations that can selectively eliminate T-cell leukemia/lymphoma cells

  2. Secondary outcome

    Time frame: Through study completion, an average of 2 years

    Analysis of DNA, RNA, protein, and circulating markers of alterations present at baseline in patient samples; profiles obtained will be correlated with response to drug treatments in order to identify biomarkers predictive of response to treatment.

  3. Secondary outcome

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

GianLuca De Salvo, MD

CONTACT

[email protected]

+390498215704

Michele Gottardi, MD

CONTACT

[email protected]

+39 0423732336

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Collaborators

  • Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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