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Chronic Lymphocytic LeukemiaPhase 3BRUIN CLL-322NCT04965493

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

A Phase 3 study testing Pirtobrutinib, Venetoclax and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 176 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirtobrutinib, Venetoclax and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
176 sitesin 23 countries
Study dates
20 Sep 2021to Oct 2027
Phase
Phase 3
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

Who may be able to join

  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
  • Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
  • Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Who cannot join

  • Known or suspected Richter's transformation at any time preceding enrollment
  • Prior therapy with a non-covalent (reversible) BTK inhibitor
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
  • Prior therapy with venetoclax
  • Central nervous system (CNS) involvement
Show all 18Show fewer
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
  • Active hepatitis B or hepatitis C
  • Known active cytomegalovirus (CMV) infection
  • Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
  • Significant cardiovascular disease
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Patients with the following hypersensitivity:
  • Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
  • Prior significant hypersensitivity to rituximab
  • Known allergy to allopurinol and inability to take uric acid lowering agent

Trial locations and contacts

176 sites in 23 countries.

176 sites in 23 countries

United States41 sites

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ironwood Physicians, Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Novant Cancer Institute Charlotte

    Charlotte, North Carolina, 28204

  • University of Virginia Health System

    Charlottesville, Virginia, 22908-0816

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The James Cancer Hospital

    Columbus, Ohio, 43210

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Mission Cancer and Blood

    Des Moines, Iowa, 50309

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Oncology Associates of Bridgeport P.C.

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC - Lee Highway

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916-2233

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Pikeville Medical Center, Inc.

    Pikeville, Kentucky, 41501

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0070

  • Mayo Clinic

    Rochester, Minnesota, 55905-0002

  • Cancer Specialists of North Florida -St Augustine

    Saint Augustine, Florida, 32086

  • USO - Texas Oncology - San Antonio

    San Antonio, Texas, 78240

  • Scripps Mercy Hospital

    San Diego, California, 92111

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104-2092

  • Swedish Cancer Institute; STE 1020

    Seattle, Washington, 98104

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Northwest Cancer Specialists PC

    Vancouver, Washington, 98684

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893

Other trials in United States

China27 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • The Second Xiangya Hospital of Central South University

    Changsha, 410008

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Fujian Provincial Cancer Hospial

    Fuzhou, 350014

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510000

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, 310003

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • The First Affiliated Hospital Of University Of South China

    Hengyang, 421001

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 010050

  • The First People's Hospital of Yunnan Province

    Kunming, 650034

  • Jiangxi Provincial Cancer Hospital

    Nanchang, 330029

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530021

  • Nantong Tumor Hospital

    Nantong, 226000

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266555

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, 200025

  • Shanghai Tongren Hospital

    Shanghai, 200336

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Wuhan Union Hospital

    Wuhan, 430022

  • Wu Han Tongji Hospital

    Wuhan, 430030

  • Wuxi People's Hospital

    Wuxi, 214023

  • Yichang Central People's Hospital

    Yichang, 443003

  • Henan Provincial People's Hospital

    Zhengzhou, 450003

  • Henan Cancer Hospital

    Zhengzhou, 450008

  • Zhongshan City People's Hospital

    Zhongshan, 528403

Other trials in China

Spain14 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Puerta De Hierro

    Majadahonda, 28222

  • Hospital Costa Del Sol

    Marbella, 29600

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitario de Toledo

    Toledo, 45007

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Italy13 sites

  • IRCCS - AOU di Bologna

    Bologna, 40138

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, 88100

  • AOU Arcispedale Sant'Anna

    Cona, 44124

  • Ospedale Santa Croce e Carle

    Cuneo, 12100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

    Milan, 20162

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • A.O.U. di Modena

    Modena, 41224

  • Azienda Ospedale Maggiore Della Carita

    Novara, 28100

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168

  • Policlinico Umberto I - Haematology

    Rome, 00161

  • A.O.U. Citta' della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

France12 sites

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • Hopital Saint Eloi

    Montpellier, 34295

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Morvan, 54511

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75010

  • Hopital de la Pitie Salpetriere

    Paris, 75651

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Pole Regionalde Cancérologie(CHU de Poitiers)

    Politiers, 86021

  • Hôpital de Pontchaillou

    Rennes, 35033

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

    Rouen, 76038

  • ICANS_Institut de Cancerologie Strasbourg Europe

    Strasbourg, 67033

  • CHRU De Tours

    Tours, 37044

Other trials in France

Japan10 sites

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113-8519

  • National Cancer Center Hospital East

    Chiba-Ken, 277 8577

  • University of Yamanashi Hospital

    Chūō, 409-3821

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • University of Fukui Hospital

    Fukui, 9101193

  • Japanese Foundation for Cancer Research

    Kōtō City, 135-8550

  • Kyoto Furitsu Medical University Hospital

    Kyoto, 602-8566

  • Kochi Medical School Hospital

    Nankoku, 783-8505

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka City General Hospital

    Osaka, 534-0021

Other trials in Japan

Germany7 sites

  • Klinikum Chemnitz GmbH

    Chemnitz, 09131

  • Universtitätsklinikum Essen AöR

    Essen, 45147

  • Uniklinik Köln

    Kerpener, 50937

  • München Klinik Schwabing

    Koelner Platz 1, 80804

  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Hämatologie

    Leipzig, 04103

  • Unimedizin RostockZIM III -Haemtologie

    Rostock, 18057

  • Gemeinschaftspraxis Dres. Schöttker & Pretscher, z.Hd. Sophie Enz

    Würzburg, 97080

Other trials in Germany

Poland7 sites

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519

  • Pratia Onkologia Katowice

    Katowice, 40519

  • Pratia MCM Krakow

    Krakow, 30-510

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz, 93510

  • Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • Instytut Hermatologii I Transfuzjologii

    Warsaw

Other trials in Poland

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Peninsula Private Hospital

    Frankston, 3199

  • Royal Hobart Hospital

    Hobart, 7000

  • The Alfred Hospital

    Melbourne, 3004

  • St Vincent's Hospital

    Melbourne, 3065

  • Sir Charles Gairdner Hospital

    Perth, 6009

Other trials in Australia

Canada6 sites

  • Foothills Medical Centre

    Calgary, T2N 2T9

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • Jewish General Hospital

    Montreal, H3T 1E2

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

  • BC Cancer Vancouver

    Vancouver, V5Z 4E6

  • Cancer Care Manitoba

    Winnipeg, R3A 1M3

Other trials in Canada

United Kingdom6 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • St James's University Hospital

    Leeds, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Israel5 sites

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Galilee Medical Center

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Belgium3 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Groupe Jolimont

    La Louvière, 7100

  • CHU UCL Namur site Godinne

    Yvoir, 5530

Other trials in Belgium

Hungary2 sites

  • National Institute of Oncology

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

Other trials in Hungary

Ireland2 sites

  • Mater Misericordiae Hospital

    Dublin

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Norway2 sites

  • Akershus Universitetssykehus

    Nordbyhagen, 1474

  • St-Olavs Hospital

    Trondheim, 7006

Other trials in Norway

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Sweden2 sites

  • Skanes Universitetssjukhus, Hematoloaimottagningen

    Lund, 22185

  • Karolinska Universitetssjukhuset i Solna

    Stockholm, 17176

Other trials in Sweden

Switzerland2 sites

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Luzerner Kantonsspital

    Lucerne, 6000

Other trials in Switzerland

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2200

Other trials in Denmark

Singapore1 site

  • Singapore General Hospital

    Singapore, 169078

Other trials in Singapore

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Being tested
Pirtobrutinib, Venetoclax, Rituximab
Keywords
BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirtobrutinibDrug

    Also called LOXO-305, LY3527727

    Oral

  • VenetoclaxDrug

    Also called Venclexta, Venclyxto

    Oral

  • RituximabDrug

    Also called Rituxan, MabThera, Truxima, Riabni

    Intravenous (IV)

Study groups in NCT04965493
Study groupRoleWhat they receive
Arm A (PVR)ExperimentalFixed duration pirtobrutinib in combination with venetoclax and rituximab
Receives: Drug: Pirtobrutinib; Drug: Venetoclax; Drug: Rituximab
Arm B (VR)Active comparatorVenetoclax with rituximab
Receives: Drug: Venetoclax; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B)

    Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018

    Measured: Up to approximately 5 years

Secondary outcomes (7)

  1. To evaluate the efficacy of Arm A compared to Arm B: Progression-free survival (PFS)

    Assessments of efficacy include PFS, assessed by investigator

    Measured: Up to approximately 5 years

  2. To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS)

    Assessments of efficacy include OS

    Measured: Up to approximately 5 years

  3. To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT)

    Assessments of efficacy include TTNT

    Measured: Up to approximately 5 years

  4. To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS)

    Assessments of efficacy include EFS

    Measured: Up to approximately 5 years

  5. To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR)

    Assessments of efficacy include ORR

    Measured: Up to approximately 5 years

  6. To evaluate the efficacy of Arm A compared to Arm B in patient-reported disease-related symptoms

    Based on time to worsening of CLL/SLL-related symptoms

    Measured: Up to approximately 5 years

  7. To evaluate the efficacy of Arm A compared to Arm B in patient-reported physical functioning

    Based on time to worsening of physical functioning

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start20 Sep 2021
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients will be randomized 1:1 into Arm A and Arm B.
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965493
Sponsor's protocol ID
18087
Other IDs
J2N-OX-JZNO, LOXO-BTK-20022
Acronym
BRUIN CLL-322
Status last verified
Jan 2026
First submitted
15 Jul 2021
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Davids MS, Eyre TA, Woyach JA, Roeker LE, Ferrajoli A, Wang Y, Tam CS, Jurczak W, Zinzani PL, Simkovic M, Li JY, Bosch F, Roos-Weil D, Cramer P, Osterborg A, Islam P, Jacobs R, Skarbnik A, Bhat SA, Kang S, Chen M, Nguyen B, McNeely SC, Chung KL, Oliveira JM, Ito R, Ghia P, Wierda WG. Fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (BRUIN CLL-322): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet. 2026 Aug 1;408(10553):453-470. doi: 10.1016/S0140-6736(26)01204-3. Epub 2026 Jul 9.

    PubMed 42425121

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pirtobrutinib, Venetoclax and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Loxo Oncology, Inc. at 176 sites in 23 countries.

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 6 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, China, Spain, Italy, France and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965493, which also lists 1 linked publication.

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 29 Jan 2026.

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