Clinical trial NCT06600568: Novel Therapeutic Approach for Human T-cell Malignancies
Official title: Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways As a Novel Therapeutic Approach for Human T-cell Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Secondary outcome
timeFrame: Through study completion, an average of 2 years
measure: Secondary outcome
timeFrame: Through study completion, an average of 2 years
measure: Secondary outcome
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G.Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
References: