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Relapsed or Refractory Follicular LymphomaPhase 3CelestimoNCT04712097

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

A Phase 3 study testing Mosunetuzumab, Lenalidomide and Rituximab in people with Relapsed or Refractory Follicular Lymphoma, run by Hoffmann-La Roche at 111 sites in 15 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

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab, Lenalidomide and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
478 participants
Where
111 sitesin 15 countries
Study dates
27 Oct 2021to 31 Dec 2029
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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Histologically documented CD20+ FL (Grades 1-3a)
  • Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
  • Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
  • Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL. Pretreatment sample of at least 1 core-needle, excisional or incisional tumor biopsy is required. Cytological or fine-needle aspiration samples are not acceptable. Fresh pretreatment biopsy is preferred. Patients who are unable to undergo biopsy procedures may be eligible for study enrollment if an archival tumor tissue sample (preferably from the most recent relapse/persistence) as paraffin blocks or at least 15 unstained slides, or in accordance with local regulatory requirements, can be sent to the Sponsor.
  • Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
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  • Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program.
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception, including at least 1 method with a failure rate of < 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after final dose of rituximab. Women must refrain from donating eggs during this same period.
  • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 28 days after last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab. Men must refrain from donating sperm during this same period.

Who cannot join

  • Grade 3b FL
  • Any history of disease transformation and/or diffuse-large B cell lymphoma (DLBCL)
  • Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
  • Active or history of CNS lymphoma or leptomeningeal infiltration
  • Prior standard or investigational anti-cancer therapy as specified: Lenalidomide exposure within 12 months prior to Day 1 of Cycle 1; Chimeric antigen receptor T cell therapy within 30 days prior to Day 1 of Cycle 1; Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Cycle 1 Day 1; Treatment with any anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
  • Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade </= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0) prior to Day 1 of Cycle 1
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  • Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies
  • Known sensitivity or allergy to murine products
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including mannitol
  • History of erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
  • Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis
  • Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
  • Active Hepatitis B infection
  • Active Hepatitis C infection
  • Known history of HIV positive status
  • History of progressive multifocal leukoencephalopathy (PML)
  • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Other malignancy that could affect compliance with the protocol or interpretation of results
  • Active autoimmune disease requiring treatment
  • History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Prior allogeneic stem cell transplantation
  • Contraindication to treatment for thromboembolism prophylaxis
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
  • Pregnant or lactating or intending to become pregnant during the study
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Trial locations and contacts

111 sites in 15 countries.

111 sites in 15 countries

France18 sites

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64109

  • Ch De Chambery

    Chambéry, 73011

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital Claude Huriez

    Lille, 59037

  • Institut Paoli Calmettes

    Marseille, 13009

  • CHU Saint Eloi

    Montpellier, 34295

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nîmes - Hôpital Carémeau

    Nîmes, 30029

  • Hôpital Saint-Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital De Haut Leveque

    Pessac, 33604

  • Ch Lyon Sud

    Pierre-Bénite, 69495

  • Hopital De La Miletrie

    Poitiers, 86021

  • CHU de Reims

    Reims, 51100

  • CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU de Strasbourg

    Strasbourg, 67098

Other trials in France

United States17 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Johns Hopkins Uni

    Baltimore, Maryland, 21231

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46804

  • Cancer & Hematology Center of West Michigan

    Grand Rapids, Michigan, 49503

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336-7774

  • NYU Long Island Hospital

    Mineola, New York, 11501

  • NYU Langone Ambulatory Care Center

    New York, New York, 10016

  • Investigative Clinical Research of Indiana, LLC

    Noblesville, Indiana, 46062

  • Washington University

    St Louis, Missouri, 63110

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Wake Forest Univ Health Svcs

    Winston-Salem, North Carolina, 27157

Other trials in United States

China15 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • The First Hospital of Jilin University

    Changchun, 130021

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330200

  • Jiangsu Province Hospital

    Nanjing, 210036

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, 301636

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Japan8 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Mie University Hospital

    Mie, 514-8507

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Okayama University Hospital

    Okayama, 700-8558

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Germany7 sites

  • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

    Berlin, 10967

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307

  • Universitätsklinikum Halle

    Halle, 06120

  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

    Heidelberg, 69120

  • Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg

    Regensburg, 93053

  • Universitätsklinik Rostock

    Rostock, 18057

  • Universtitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Samsung Medical Center

    Seoul, (0)6351

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Seoul St Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Italy6 sites

  • Ospedali Riuniti Umberto I

    Ancona, The Marches, 60100

  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

    Padova, Veneto, 35128

  • Ospedale V. Cervello

    Palermo, Sicily, 90146

  • U.O. Ematologia AUSL Ravenna

    Ravenna, Emilia-Romagna, 48121

Other trials in Italy

Poland6 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519

  • Pratia Onkologia Katowice

    Katowice, 41-500

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367

Other trials in Poland

Spain5 sites

  • Hospital de Donostia

    Guipuzcoa, Guipuzcoa, 20014

  • Hospital Universitario la Paz

    Madrid, 28046

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Geelong Hospital

    Geelong, Victoria, 3220

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil4 sites

  • Ictrials Pesquisa e Desenvolvimento

    Curitiba, Paraná, 80510-130

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

Other trials in Brazil

Taiwan4 sites

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaoisung, 833

  • National Taiwan Universtiy Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • Hacettepe Uni Medical Faculty

    Ankara, 06100

  • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,

    Istanbul, 34303

  • Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?

    Istanbul

  • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

    Sariyer, 34450

Other trials in Turkey (Türkiye)

United Kingdom4 sites

  • Royal Cornwall Hospitals NHS Trust

    Cornwall, TR1 3LJ

  • Hammersmith Hospital

    London, W12 0HS

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Torbay Hospital

    Torquay, TQ2 7AA

Other trials in United Kingdom

Russia2 sites

  • City Clinical Botkin's Hospital

    Moscow, 125284

  • Penza Regional Oncology Dispensary

    Penza, 440071

Other trials in Russia

About this study

Official title: Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

Being tested
Mosunetuzumab, Lenalidomide, Rituximab, Tociluzumab
Medical subject headings
Recurrence, Lymphoma, Follicular

What participants receive

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

  • MosunetuzumabDrug

    Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12

  • LenalidomideDrug

    Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)

  • RituximabDrug

    Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11

  • TociluzumabDrug

    Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events

Study groups in NCT04712097
Study groupRoleWhat they receive
M + Len (Arm A)ExperimentalParticipants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Receives: Drug: Mosunetuzumab; Drug: Lenalidomide; Drug: Tociluzumab
R + Len (Arm B)ExperimentalParticipants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)
Receives: Drug: Lenalidomide; Drug: Rituximab; Drug: Tociluzumab
M + Len (US Extension Arm C)ExperimentalParticipants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Receives: Drug: Mosunetuzumab; Drug: Lenalidomide; Drug: Tociluzumab

What is being measured

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

  1. Progression Free Survival (PFS) according to 2014 Lugano Response Criteria

    Measured: From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8.5 years)

Secondary outcomes (13)

  1. PFS as Determined by the Investigator

    Measured: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8.5 years)

  2. Complete Response Rate

    Measured: Up to approximately 8.5 years

  3. Objective Response Rate (ORR)

    Measured: Up to approximately 8.5 years

  4. Overall Survival (OS)

    Measured: From randomization to death from any cause (up to approximately 8.5 years)

  5. Duration of Objective Response (DOR)

    Measured: From the first occurrence of a documented objective response (complete response or partial response) to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 years)

  6. Duration of Complete Reponse (DOCR)

    Measured: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8.5 years)

  7. Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)

    Measured: Up to approximately 8.5 years

  8. Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)

    Measured: Up to approximately 8.5 years

  9. Percentage of Participants with Adverse Events (AEs)

    Measured: Up to approximately 8.5 years

  10. Serum Concentration of M + Len

    Measured: Up to approximately 8.5 years

  11. Area Under the Curve (AUC) of M + Len

    Measured: Up to approximately 8.5 years

  12. Percentage of Participants with Anti-Drug Antibodies (ADAs)

    Measured: Up to approximately 8.5 years

  13. Time to New Anti-Lymphoma Treatment (TTNALT)

    Measured: From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8.5 years)

Timeline

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

  1. First posted15 Jan 2021
  2. Study start27 Oct 2021
  3. Primary completion3 Jun 2026
  4. Study completion31 Dec 2029 (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
Masking
None (open label)
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712097
Sponsor's protocol ID
GO42909
Other IDs
2020-005239-53
Acronym
Celestimo
Status last verified
Oct 2026
First submitted
13 Jan 2021
Last updated
8 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mosunetuzumab, Lenalidomide and Rituximab in people with Relapsed or Refractory Follicular Lymphoma, run by Hoffmann-La Roche at 111 sites in 15 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 9 inclusion and 31 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in France, United States, China, Japan, Germany and 10 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?

Progression Free Survival (PFS) according to 2014 Lugano Response Criteria (time frame: From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8.5 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 NCT04712097.

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 8 Oct 2026.

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