Hodgkin LymphomaPhase 2FIL_Tisle-HLNCT05977673
Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy
A Phase 2 study testing Tislelizumab in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 12 sites in Italy.
Trial summary
This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 12 sitesItaly
- Study dates
- 23 May 2024to Nov 2030
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL). Note: Availability of either block or unstained slides plus stained slides used by the local pathologist to make diagnosis, and of all pathology reports is mandatory for the study to perform central pathology review for confirmation of cHL diagnosis and for biological biomarkers assessments. Central pathology confirmation is not required to start treatment;
- Patients >= 65 years ineligible for frontline standard chemotherapy (mainly due to medical comorbidities);
- Treatment naïve;
- Measurable disease defined as presence of both fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion measurable in two diameters (and at least 1.5 cm in its major diameter); • Indication for systemic treatment, i.e., all stages except IA without a large tumor burden, as radiotherapy is regarded curative in those patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2;
- Adequate organ and marrow function as defined below:
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- Absolute neutrophil count (ANC) > 109/L (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvement by lymphoma
- Platelet > 50 x 109/L (without growth factor support or transfusion within 7 days of platelets measurement) , unless due to bone marrow involvement by lymphoma
- Hemoglobin > 8 g/dL (prior transfusion is acceptable)
- Creatinine clearance ≥ 30 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24-hour urine collection)
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤ 3.0 × upper limit of normal (ULN)
- Serum total bilirubin < 1.5 × ULN (or < 3 x ULN in case of documented Gilbert's syndrome)
- Life expectancy ≥ 6 months;
- Men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 4 months after last tislelizumab dose. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control method, e.g. vasectomy, use of condoms or complete sexual abstinence, when this is in line with the preferred and usual lifestyle of the subject.The use of condoms by male patients is required unless the female partner is permanently sterile. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception.
- Subject voluntarily signs and dates an informed consent form approved by an National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures, indicating that they understand the purpose of and procedures required for the study and are willing to participate in it;
- Subject must be able to adhere to the study visit schedule and other protocol requirements, and to return to enrolling institution for follow-up (during the active monitoring phase of the study).
Who cannot join
- Nodular lymphocyte predominant HL;
- Any previous treatment (including radiation therapy) for HL;
- Any active autoimmune disease requiring systemic treatment (including disease-modifying agents, corticosteroids, immunosuppressants) in the past 2 years; Note: Patients with the following diseases are not excluded and may proceed to further screening: Type I diabetes under control; Hypothyroidism (provided it is managed with hormone replacement therapy only); Controlled celiac disease;
- Has known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of dyspnea at rest or pulse oximetry of < 92% while breathing room air;
- A history of previous exposure to anti-PD1, anti-PDL1 or anti-PDL2 or anti-CTLA-4 agents for any disease other than HL;
- Use of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days from registration; Note: Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
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- Known infection with HIV, human T-cell lymphotropic virus-1, -2; • Serologic status reflecting active hepatitis B defined as presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (mandatory testing). Patients with occult or prior HBV infection (respectively defined as patient with HBsAg-/HBcAb+ and patients HBsAg+ with HBV DNA undetectable) are eligible, provided that they are willing to undergo prophylactic antiviral medication according to local standard of care. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination are eligible;
- Presence of hepatitis C virus (HCV) antibody (mandatory HCV antibody serology testing). Patients with presence of HCV antibody are eligible only if PCR is negative for HCV RNA;
- Hypersensitivity to tislelizumab or any of its excipients;
- Active central nervous system (CNS) involvement or leptomeningeal metastases involvement;
- Evidence of other clinically significant uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens;
- Major surgery within 4 weeks of the first dose of study drug;
- Vaccination with a live vaccine within 4 weeks prior to the first dose of study drug;
- Clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening;
- Unstable angina within 3 months before screening;
- New York Heart Association Classification III or IV congestive heart failure;
- History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes);
- QTcF > 480 msecs based on Fridericia's formula;
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
- Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mm Hg and diastolic blood pressure > 105 mm Hg at screening;
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;
- Any history of other active malignancies within 3 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent;
- History of severe hypersensitivity reactions to other monoclonal antibodies;
- Concurrent participation in another therapeutic clinical trial.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Alessandria, IT
Manuela Zanni, MD, manuela.zanni@ospedale.al.it
Manuela Zanni, MD
- Recruiting
Divisione di Oncologia e dei Tumori immuto-correlati, Centro Di Riferimento Oncologico Di Aviano
Aviano
Michele Spina, MD, mspina@cro.it
Michele Spina, MD
- Recruiting
Istituto di Ematologia L. e A. Seràgnoli, AOU Policlinico S. Orsola-Malpighi
Bologna
Pier Luigi Zinzani, MD, pierluigi.zinzani@unibo.it
Pier Luigi Zinzani, MD
- Recruiting
SC Ematologia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia
Alessandra Tucci, MD, alessandra.tucci@asst-spedalicivili.it
Alessandra Tucci, MD
- Recruiting
Ematologia, Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan
Chiara Rusconi, MD, chiara.rusconi@istitutotumori.mi.it
Chiara Rusconi, MD
- Recruiting
Unità di Ematologia e TMO - Unità Linfomi, Ospedale San Raffaele
Milan
Andrés J.M. Ferreri, MD, andres.ferreri@hsr.it
Andrés J.M. Ferreri, MD
- Recruiting
Oncologia, IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples
Antonio Pinto, MD, a.pinto@istitutotumori.na.it
Antonio Pinto, MD
- Not yet recruiting
SCDU Ematologia - AOU Maggiore della Caritа di Novara
Novara
Gloria Margiotta, gloria.margiotta@med.uniupo.it
Gloria Margiotta, MD
- Recruiting
Oncoematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo
Caterina Patti, MD, k.patti@villasofia.it
Caterina Patti, MD
- Not yet recruiting
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia
Angela Ferrari, ferrari.angela@ausl.re.it
Angela Ferrari, MD
- Recruiting
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Azienda Ospealiero Universitaria Policlinico Umberto I
Roma
Ilaria Del Giudice, MD, ilaria.delgiudice@uniroma1.it
Ilaria Del Giudice, MD
- Recruiting
U.O di Oncologia Medica ed Ematologia, Humanitas Research Hospital
Rozzano
Francesca Ricci, MD, francesca.ricci@humanitas.it
Francesca Ricci, MD
About this study
Official title: Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy: a Phase II, Open-label Study
This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy.
Read the detailed description
Approximately two-thirds of patients with Hodgkin lymphoma (HL) can be cured with standard frontline chemotherapy with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). The majority of new patients present in the second and third decade of life, but at least 25% of de novo cases are in patients older than 65. Elderly patients with HL display dismal outcomes for several reasons: the disease is implicitly more aggressive than in younger adults, with an advanced stage in at least two-thirds of cases and the presence of multiple risk factors for poor outcome (according to the International Prognostic Score). Moreover, patients may show impaired organ function that require chemotherapy dose reductions, treatment delays or drug withdrawal.
Given the difficulty of delivering of full treatment doses to elderly patients and to those with relevant medical comorbidities, there is a need for new and better tolerated agents in this context.
Given the difficulty of delivering of full treatment doses to elderly patients and to those with relevant medical comorbidities, there is a need for new and better tolerated agents in this context. Importantly, no single agent has received approval for this kind of patients, and drugs like gemcitabine and bendamustine - both active in relapsed patients with limited toxicity - have limitations in their prescription. The anti-CD30 immunoconjugate agent brentuximab vedotin (BV) applied in patients older than 60 years and considered unsuitable for frontline chemotherapy, yielded an overall response of 92%, with 73% of patients achieving a complete remission and a median duration of response of 9.1 months.
Immune checkpoint inhibitors, namely nivolumab and pembrolizumab, have been largely tested in patients with relapsed and refractory HL failing both autologous stem cell transplant and BV. Both agents display efficacy in this context, with significant rates of objective responses, which appear to be durable. Along with an acceptable safety profile, both agents have been approved in relapsed and refractory HL, providing a good treatment option for heavily pretreated patients. Tislelizumab (T, BGB-A317) is a humanized IgG4 mAb with high affinity and specificity for programmed cell death protein 1 (PD1), showing a superior antitumor activity compared to nivolumab in mice transplanted with human cancer cells and peripheral blood mononuclear cells. High response rates have been reported in Chinese HL patients who have failed or were ineligible to autologous transplantation, including a complete response rate of 61% and a partial response rate of 24%.
Investigators postulate that an induction based on single-agent tislelizumab can be a feasible chemo-free treatment strategy to be offered to patients with de novo HL who are unsuitable for a chemotherapy-based frontline approach.
The study also addresses biological evaluation of biomarkers in the tumor clone and in the microenvironment at baseline and their possible correlation with patients' outcome and responses.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Tislelizumab
- Keywords
- Lymphoma, Hodgkin, Tislelizumab, PD1, Checkpoint, Inhibitor, De novo, Unsuitable, Chemotherapy, Immune
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200mg IV day1
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab | Experimental | Tislelizumab single dose every 3 weeks up to 35 total administration Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (CR + PR)
The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).
Measured: From treatment start up to about 24 months
Secondary outcomes (5)
Duration of response (DoR)
Time from first documented complete response according to Lugano and LYRIC criteria to disease relapse.
Measured: Between +33 days after treatment start up to 66 months
Progression-free survival (PFS)
Time from registration to the earliest date of documentation of disease progression, relapse or death from any cause.
Measured: From registration up to 66 months
Overall survival (OS)
Time from registration to death from any cause.
Measured: From registration up to 66 months
Disease free survival (DFS)
Time from first documented complete response according to Lugano and LYRIC criteria to disease relapse or death as a result of lymphoma or acute toxicity of treatment.
Measured: Between +33 days after treatment start up to 66 months
Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse events occurred from the IC signed to the end of the study (LPLV)
To evaluate the safety and tolerability of tislelizumab
Measured: From treatment start up to 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start23 May 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, Istituto di Ematologia "L. e A. Seràgnoli", AOU Policlinico S.Orsola-Malpighi, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977673
- Sponsor's protocol ID
- FIL_Tisle-HL
- Acronym
- FIL_Tisle-HL
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy: a Phase II, Open-label Study
- ClinicalTrials.gov ID
- NCT05977673
- Acronym / sponsor ID
- FIL_Tisle-HL / FIL_Tisle-HL
- Conditions
- Hodgkin Lymphoma
- Keywords
- Lymphoma, Hodgkin, Tislelizumab, PD1, Checkpoint, Inhibitor, De novo, Unsuitable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 4 Aug 2023 (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 is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy.
Detailed description
Approximately two-thirds of patients with Hodgkin lymphoma (HL) can be cured with standard frontline chemotherapy with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). The majority of new patients present in the second and third decade of life, but at least 25% of de novo cases are in patients older than 65. Elderly patients with HL display dismal outcomes for several reasons: the disease is implicitly more aggressive than in younger adults, with an advanced stage in at least two-thirds of cases and the presence of multiple risk factors for poor outcome (according to the International Prognostic Score). Moreover, patients may show impaired organ function that require chemotherapy dose reductions, treatment delays or drug withdrawal.
Given the difficulty of delivering of full treatment doses to elderly patients and to those with relevant medical comorbidities, there is a need for new and better tolerated agents in this context.
Given the difficulty of delivering of full treatment doses to elderly patients and to those with relevant medical comorbidities, there is a need for new and better tolerated agents in this context. Importantly, no single agent has received approval for this kind of patients, and drugs like gemcitabine and bendamustine - both active in relapsed patients with limited toxicity - have limitations in their prescription. The anti-CD30 immunoconjugate agent brentuximab vedotin (BV) applied in patients older than 60 years and considered unsuitable for frontline chemotherapy, yielded an overall response of 92%, with 73% of patients achieving a complete remission and a median duration of response of 9.1 months.
Immune checkpoint inhibitors, namely nivolumab and pembrolizumab, have been largely tested in patients with relapsed and refractory HL failing both autologous stem cell transplant and BV. Both agents display efficacy in this context, with significant rates of objective responses, which appear to be durable. Along with an acceptable safety profile, both agents have been approved in relapsed and refractory HL, providing a good treatment option for heavily pretreated patients. Tislelizumab (T, BGB-A317) is a humanized IgG4 mAb with high affinity and specificity for programmed cell death protein 1 (PD1), showing a superior antitumor activity compared to nivolumab in mice transplanted with human cancer cells and peripheral blood mononuclear cells. High response rates have been reported in Chinese HL patients who have failed or were ineligible to autologous transplantation, including a complete response rate of 61% and a partial response rate of 24%.
Investigators postulate that an induction based on single-agent tislelizumab can be a feasible chemo-free treatment strategy to be offered to patients with de novo HL who are unsuitable for a chemotherapy-based frontline approach.
The study also addresses biological evaluation of biomarkers in the tumor clone and in the microenvironment at baseline and their possible correlation with patients' outcome and responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab | Experimental | Drug: TislelizumabTislelizumab single dose every 3 weeks up to 35 total administration |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL). Note: Availability of either block or unstained slides plus stained slides used by the local pathologist to make diagnosis, and of all pathology reports is mandatory for the study to perform central pathology review for confirmation of cHL diagnosis and for biological biomarkers assessments. Central pathology confirmation is not required to start treatment;
- Patients >= 65 years ineligible for frontline standard chemotherapy (mainly due to medical comorbidities);
- Treatment naïve;
- Measurable disease defined as presence of both fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion measurable in two diameters (and at least 1.5 cm in its major diameter); • Indication for systemic treatment, i.e., all stages except IA without a large tumor burden, as radiotherapy is regarded curative in those patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2;
Key exclusion criteria (26 listed)
- Nodular lymphocyte predominant HL;
- Any previous treatment (including radiation therapy) for HL;
- Any active autoimmune disease requiring systemic treatment (including disease-modifying agents, corticosteroids, immunosuppressants) in the past 2 years; Note: Patients with the following diseases are not excluded and may proceed to further screening: Type I diabetes under control; Hypothyroidism (provided it is managed with hormone replacement therapy only); Controlled celiac disease;
- Has known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of dyspnea at rest or pulse oximetry of < 92% while breathing room air;
- A history of previous exposure to anti-PD1, anti-PDL1 or anti-PDL2 or anti-CTLA-4 agents for any disease other than HL;
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 |
|---|---|---|
| TislelizumabTislelizumab 200mg IV day1 | Drug | Tislelizumab |
Primary outcome
Overall Response Rate (CR + PR)
Time frame: From treatment start up to about 24 months
The primary endpoint of the study is the ORR (the sum of complete response (CR) and partial response (PR) rate).
5 secondary outcomes
Duration of response (DoR)
Time frame: Between +33 days after treatment start up to 66 months
Progression-free survival (PFS)
Time frame: From registration up to 66 months
Overall survival (OS)
Time frame: From registration up to 66 months
Disease free survival (DFS)
Time frame: Between +33 days after treatment start up to 66 months
Incidence and severity of adverse events occurred during therapy and up to 90 days after treatment and incidence and severity of serious adverse events occurred from the IC signed to the end of the study (LPLV)
Time frame: From treatment start up to 66 months
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 19 Aug 2026.
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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.
Pier Luigi Zinzani, MD principal investigator
Istituto di Ematologia "L. e A. Seràgnoli", AOU Policlinico S.Orsola-Malpighi, Bologna
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 12 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 16 inclusion and 26 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 19 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 12 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (CR + PR) (time frame: From treatment start up to about 24 months). 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 19 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.