Novel Therapeutic Approach for Human T-cell Malignancies
ConditionT-Cell Leukemia/Lymphoma, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Oncologico Veneto IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Translation analysis
Other interventionNovel strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Secondary outcome
Development of drug combinations that can selectively eliminate T-cell leukemia/lymphoma cells
Time frame
Through study completion, an average of 2 years2
Secondary outcome
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.
Time frame
Through study completion, an average of 2 years3
Secondary outcome
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.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Oncologico Veneto IRCCS
Lead sponsor
Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale
Collaborator
Source ClinicalTrials.gov