New treatment approach for T-cell cancers
Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a Novel Therapeutic Approach for Human T-cell Malignancies
This study is testing a new way to treat T-cell cancers by combining different drugs to see if they can help get rid of cancerous T cells in patients who haven't responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Locations | 2 sites (Naples and 1 other locations) |
| Trial ID | NCT06600568 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to identify innovative strategies to selectively eliminate malignant T cells by modulating intracellular reactive oxygen species (ROS) levels. It will investigate the interactions between drugs that activate apoptosis, such as Venetoclax, and those that alter ROS homeostasis, like glucose-6-phosphate dehydrogenase inhibitors. The most promising compounds will be selected based on in vitro results from cell lines and patient-derived xenografts (PDX), and subsequently tested ex vivo on cells from patients with resistant or refractory T-cell neoplasms.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with pre- and post-thymic T-cell leukemia or lymphoma.
Not a fit: Patients with serious illnesses or uncontrolled infections that prevent standard treatment management may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatments for patients with T-cell malignancies.
How similar studies have performed: While this approach is innovative, similar studies exploring ROS modulation in cancer treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Naples and 1 other locations
- Istituto Nazionale Tumori Fondazione G.Pascale — Naples, Italy (Recruiting)
- Istituto Oncologico Veneto — Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Michele Gottardi, MD
- Email: michele.gottardi@iov.veneto.it
- Phone: +39 0423732336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.