T-Cell Leukemia/Lymphoma, AdultNCT06600568
Novel Therapeutic Approach for Human T-cell Malignancies
An observational study of T-Cell Leukemia/Lymphoma, Adult, run by Istituto Oncologico Veneto IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-Cell Leukemia/Lymphoma, Adult
- What is being tested?
- Translation analysis
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 18 Mar 2025to 1 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -Serious illness or medical condition that does not allow the patient to be managed according to standard treatment protocols, including uncontrolled active infection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Nazionale Tumori Fondazione G.Pascale
Naples, 80100
Antonio Pinto, MD, 081/1777-0368, a.pinto@istitutotumori.na.it
- Recruiting
Istituto Oncologico Veneto
Padova, 35128
Michele Gottardi, MD, +39 0423-732336, michele.gottardi@iov.veneto.it
About this study
Official title: Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a 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.
- Conditions
- T-Cell Leukemia/Lymphoma, Adult
- Being tested
- Translation analysis
- Keywords
- T-cell lymphoblastic leukemias (T-ALL), T-cell non-Hodgkin's lymphomas (T-NHL), NK cell neoplasia, ROS, apoptosis
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translation analysisOther
Novel strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Secondary outcome
Development of drug combinations that can selectively eliminate T-cell leukemia/lymphoma cells
Measured: Through study completion, an average of 2 years
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.
Measured: Through study completion, an average of 2 years
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Leukemia/Lymphoma, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600568
- Sponsor's protocol ID
- ROSinTALL
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a Novel Therapeutic Approach for Human T-cell Malignancies
- ClinicalTrials.gov ID
- NCT06600568
- Acronym / sponsor ID
- ROSinTALL
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Serious illness or medical condition that does not allow the patient to be managed according to standard treatment protocols, including uncontrolled active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translation analysisNovel strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels. | Other | – |
Primary outcome
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
3 secondary outcomes
Secondary outcome
Time frame: Through study completion, an average of 2 years
Secondary outcome
Time frame: Through study completion, an average of 2 years
Secondary outcome
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T-Cell Leukemia/Lymphoma, Adult, run by Istituto Oncologico Veneto IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Gottardi, MD (+39 0423732336, michele.gottardi@iov.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.