NCT07321652ClinicalTrials.gov

Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL

Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 3466 participants recherchés210 sites1 pays

Catégories

Oncologie82%Hématologie12%Immunologie et rhumatologie6%

Enregistré dans 1 registre

ClinicalTrials.govNCT07321652Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 3 semaines

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-01-07; recorded start 2026-04-30
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 95 other studies in this databaseCounted from the lead sponsor named in the record (Alliance for Clinical Trials in Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: other.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 152 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 466 participants (target), run at 210 sites.

How this score is built

Enrolment26/40
466 participants (target)
Site count24/25
152 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 151 months
Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL/SLL.

PRIMARY OBJECTIVES: I. To compare the progression free survival (PFS) between minimal residual disease (MRD)-guided zanubrutinib sonrotoclax therapy to continuous zanubrutinib as control. II. To determine the PFS comparing fixed duration zanubrutinib sonrotoclax therapy to continuous zanubrutinib as control. SECONDARY OBJECTIVES: I. To compare the PFS between the patients with MRD-detectable disease treated with fixed duration zanubrutinib sonrotoclax to the PFS of the patients with MRD detectable disease who receive one additional year of combination therapy. II. To determine the overall survival of all arms of the study. III. To determine the frequency of patients with MRD-detectable disease who convert to undetectable MRD, and at what depth and for how long, after receiving an extra year of combination therapy on the MRD-guided zanubrutinib sonrotoclax therapy arm. IV. To determine and compare the overall response rate (ORR defined as PR, CR, CCR, CRi) and complete remission rate (CR) after 14 cycles of therapy among the three arms. V. To compare time to the next CLL/SLL therapy among treatment arms. VI. To determine the rates and severity of toxicity in each arm, with a particular focus on adverse events of special interest that include infections, cardiovascular events (arrhythmias, heart failure, hypertension), tumor lysis syndrome, bleeding events, cytopenias, and second malignancies. VII. To compare patient-reported symptomatic adverse events as assessed by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE) between arms 1 and 2. EXPLORATORY OBJECTIVES: I. To compare the best achieved rate of undetectable MRD (uMRD) between the fixed duration zanubrutinib sonrotoclax arm and the MRD guided zanubrutinib sonrotoclax arm. II. To compare rates of undetectable MRD measured by the immunoglobulin heavy chain (IGH) sequencing assay ClonoSeq (sensitivity 1 in 10\^-6) to undetectable MRD measured by standard six-color flow cytometry (uMRD4), and to compare results from bone marrow to peripheral blood. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with at least partial remission continue therapy as described above. Patients with progressive disease proceed to follow up. Patients undergo computed tomography (CT) scan, bone marrow aspiration and blood sample collection throughout the study. ARM 2: Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Starting cycle 4 day 1 patients also receive sonrotoclax PO daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with undetectable MRD and a response of PR, partial response with persistent lymphocytosis (PR-L), CR, CCR or CRi stop therapy at cycle 15 day 28 and proceed to follow up. Patients with detectable MRD and an objective response to therapy are re-randomized to arm 2B or arm 2C. ARM 2B: Patients continue zanubrutinib PO BID sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for an additonal 12 cycles in the absence of disease progression or unacceptable toxicity. ARM 2C: Patients discontinue therapy starting at cycle 15 day 28 and proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection throughout the study. After completion of study treatment, patients are followed up every 3 months for 3 years then every 6 months until 10 years for study registration. Patients with progression or the start of non protocol CLL directed therapy are followed every 6 months for 10 years from registration.

Affections

Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia

Éligibilité

Éligibilité
Sexe	Tous
Âges	65 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility * STEP 0: Patients must be diagnosed with CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following: * ≥ 5 x10\^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL) * On morphologic review, the leukemic cells must be small mature lymphocytes * Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \> 10% of cells must lack t(11;14) translocation by interphase cytogenetics * STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria: * Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \< 10 g/dL, platelet count \< 100,000/mm\^3 * Massive (\> 6 cm below the costal margin), progressive or symptomatic splenomegaly * Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy * Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy * Constitutional symptoms, which include any of the following: * Unintentional weight loss of ≥ 10% within the previous 6 months * Significant fatigue (ie. Eastern Cooperative Oncology Group \[ECOG\] performance status \[PS\] ≥ 2) * Fevers \>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection * Night sweats \> 1 month without evidence of infection * STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids) * STEP 0: Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration * STEP 0: Age ≥ 65 years * STEP 0: ECOG performance status ≤ 2 * STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial * STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment * STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better. Patients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment * STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage * STEP 0: No patients with known active progressive central nervous system (CNS) disease * STEP 0: No known medical condition causing an inability to swallow oral formulations of agents * STEP 1: The adaptive report confirming a measurable and trackable B cell clone * STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician * STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document * STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily * STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics * STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4/5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug * STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mm3 unless due to marrow involvement * STEP 1: Platelet count ≥ 30,000/mm3 * STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease) * STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver * STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL/min * STEP 1: Urine protein to creatinine ratio \< 1 or urine protein ≤ 1+ * STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ * STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	466 participants recherchés

Promoteur et collaborateurs

Alliance for Clinical Trials in Oncology Promoteur
National Cancer Institute (NCI) Collaborateurs

Groupes et interventions

Arm 1 (zanubrutinib)ACTIVE_COMPARATOR
Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with at least partial remission continue therapy as described above. Patients with progressive disease proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection throughout the study.
Arm 2 (zanubrutinib and sonrotoclax)EXPERIMENTAL
Patients receive zanubrutinib PO BID on days 1-28 of each cycle. Starting cycle 4 day 1 patients also receive sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo restaging starting at cycle 15 day 1. Patients with undetectable MRD and a response of PR, PR-L, CR, CCR or CRi stop therapy at cycle 15 day 28 and proceed to follow up. Patients with detectable MRD and an objective response to therapy are re-randomized to arm 2B or arm 2C. ARM 2B: Patients continue zanubrutinib PO BID sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for an additonal 12 cycles in the absence of disease progression or unacceptable toxicity. ARM 2C: Patients discontinue therapy starting at cycle 15 day 28 and proceed to follow up. Patients undergo CT scan, bone marrow aspiration and blood sample collection

Interventions

Intervention Biospecimen Collection
Undergo blood sample collection
Intervention Bone Marrow Aspiration
Undergo bone marrow aspiration
Intervention Computed Tomography
Undergo CT scan
Médicament Sonrotoclax
Given PO
Autre Survey Administration
Ancillary studies
Médicament Zanubrutinib
Given PO

Critères de jugement

Critère de jugement principal
Progression free survival (PFS)
From initial randomization date until the earlier of disease progression or death from any cause. PFS estimates for zanubrutinib plus sonrotoclax therapy to continuous Zanubrutinib.
Délai From initial randomization date until the earlier of disease progression or death from any cause, up to 10 years
Autre critère de jugement
PFS for patients with MRD detectable disease treated with fixed duration zanubrutinib sonrotoclax versus patients with MRD detectable disease who receive one additional year of combination therapy
Undetectable (u) MRD will be defined as \< 10 in 1,000,000 (less than 1 in 10\^-5 \[uMRD5\]) on peripheral blood, and the depth of response below that level, (i.e. down to 10\^-6 \[uMRD6\]), will also be collected. Kaplan-Meier will be used to estimate survival curves, log-rank tests to compare between survival curves, and hazard ration (HRs) and associated 95% CIs will be reported.
Délai up to 10 years
Autre critère de jugement
Overall survival
OS will be summarized using Kaplan-Meier methodology, with hazard ratios from a stratified Cox proportional hazards model and log-rank test results provided.
Délai Up to 10 years
Autre critère de jugement
Percentage of patients with MRD detectable disease who convert to uMRD after receiving an extra year of combination therapy on the MRD-guided Zanubrutinib sonrotoclax therapy arm
Proportions of number of MRD+ to uMRD conversion by total number of evaluable patients will be estimated with their corresponding 95% CIs.
Délai Up to 10 years
Autre critère de jugement
Overall response rate among treatment arms
Overall response rate is defined as the highest response achieved during the first 15 cycles of treatment. A response is defined as a patients achieving PR+.
Délai Up to 10 years
Autre critère de jugement
Time to next CLL/SLL therapy
Kaplan-Meier estimates and 95% CIs of TTNT. Time is measured as the time from the end of initial treatment to the initiation of subsequent treatment.
Délai Up to 10 years
Autre critère de jugement
Adverse Event Rates and Severity
Frequency and severity of adverse events and tolerability for each embedded treatment regimen will be collected and summarized using descriptive statistics.
Délai Up to 10 years
Autre critère de jugement
Patient-reported symptomatic adverse events
As assessed by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than 0 will be compared between arms using Fisher's exact test. Similarly, the frequency and proportion of patients with a maximum baseline-adjusted composite score greater than or equal to 3 will be compared between arms using Fisher's exact test.
Délai Up to 10 years

Dates

Dates
Date de début	30 avril 2026 (réelle)
Achèvement principal	30 septembre 2028 (estimée)
Achèvement	30 septembre 2038 (estimée)
Première publication	7 janvier 2026 (réelle)
Dernière mise à jour	2 septembre 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	septembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

206 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Avera Cancer Institute-Aberdeen	Aberdeen	South Dakota	En recrutement
Hendrick Medical Center	Abilene	Texas	En recrutement
Mary Greeley Medical Center	Ames	Iowa	En recrutement
McFarland Clinic - Ames	Ames	Iowa	En recrutement
Community Hospital of Anaconda	Anaconda	Montana	En recrutement
Kaiser Permanente-Anaheim	Anaheim	California	En recrutement
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	En recrutement
Duluth Clinic Ashland	Ashland	Wisconsin	En recrutement
OhioHealth O'Bleness Hospital	Athens	Ohio	En recrutement
Saint Alphonsus Cancer Care Center-Baker City	Baker City	Oregon	En recrutement
Kaiser Permanente-Baldwin Park	Baldwin Park	California	En recrutement
Kaiser Permanente-Bellflower	Bellflower	California	En recrutement
Sanford Joe Lueken Cancer Center	Bemidji	Minnesota	En recrutement
Billings Clinic Cancer Center	Billings	Montana	En recrutement
University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	En recrutement
Sanford Bismarck Medical Center	Bismarck	North Dakota	En recrutement
Illinois CancerCare-Bloomington	Bloomington	Illinois	En recrutement
Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	En recrutement
Dana-Farber Cancer Institute	Boston	Massachusetts	En recrutement
Bozeman Health Deaconess Hospital	Bozeman	Montana	En recrutement
Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota	En recrutement
Trinity Health IHA Medical Group Hematology Oncology - Brighton	Brighton	Michigan	En recrutement
Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho	En recrutement
Trinity Health IHA Medical Group Hematology Oncology - Canton	Canton	Michigan	En recrutement
Illinois CancerCare-Canton	Canton	Illinois	En recrutement
Saint Francis Medical Center	Cape Girardeau	Missouri	En recrutement
Saint Anthony Regional Hospital	Carroll	Iowa	En recrutement
Illinois CancerCare-Carthage	Carthage	Illinois	En recrutement
Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	En recrutement
Mercy Hospital	Cedar Rapids	Iowa	En recrutement
Cancer Center of Kansas - Chanute	Chanute	Kansas	En recrutement
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	En recrutement
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital	Chelsea	Michigan	En recrutement
Jefferson Cherry Hill Hospital	Cherry Hill	New Jersey	En recrutement
Northwestern University	Chicago	Illinois	En recrutement
University of Illinois	Chicago	Illinois	En recrutement
Siteman Cancer Center at Saint Peters Hospital	City of Saint Peters	Missouri	En recrutement
UI Health Care Mission Cancer and Blood - West Des Moines Clinic	Clive	Iowa	En recrutement
Kootenai Health - Coeur d'Alene	Coeur d'Alene	Idaho	En recrutement
Baptist Memorial Hospital and Cancer Center-Collierville	Collierville	Tennessee	En recrutement
Grant Medical Center	Columbus	Ohio	En recrutement
Riverside Methodist Hospital	Columbus	Ohio	En recrutement
Columbus Oncology and Hematology Associates Inc	Columbus	Ohio	En recrutement
Ohio State University Comprehensive Cancer Center	Columbus	Ohio	En recrutement
Doctors Hospital	Columbus	Ohio	En recrutement
Mercy Hospital	Coon Rapids	Minnesota	En recrutement
UM Sylvester Comprehensive Cancer Center at Coral Gables	Coral Gables	Florida	En recrutement
UM Sylvester Comprehensive Cancer Center at Coral Springs	Coral Springs	Florida	En recrutement
Siteman Cancer Center at West County Hospital	Creve Coeur	Missouri	En recrutement
Carle at The Riverfront	Danville	Illinois	En recrutement

160 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

2 septembre 2026
Site ajouté
28 sites added (210 total)
182210
5 août 2026
Site ajouté
30 sites added (182 total)
152182

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07321652