Waldenstrom MacroglobulinemiaPhase 2ZEBRANCT06561347
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
A Phase 2 study testing Zanubrutinib, Bendamustine and Rituximab in people with Waldenstrom Macroglobulinemia, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia
- What is being tested?
- Zanubrutinib, Bendamustine and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Dec 2024to 1 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria
- Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type
- Meeting criteria for treatment per IWWM2 criteria. At least one of the following:
- Constitutional Symptoms (at least one of the following)
- Recurrent fever
- Night sweats
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- Fatigue
- Weight loss
- Progressive or symptomatic lymphadenopathy or splenomegaly
- Hemoglobin ≤ 10 g/dL
- Platelet count ≤ 100 k/uL
- Hyperviscosity syndrome
- Symptomatic peripheral neuropathy
- Systemic amyloidosis
- Renal insufficiency
- Symptomatic cryoglobulinemia or cold agglutinemia
- Treatment naive; must have not received any prior systemic therapy for WM
- Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
- Adults age ≥18
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence1 from heterosexual intercourse during treatment and for at least 1 week after the last dose of zanubrutinib or at least 12 months after the last dose of rituximab, whichever is later. FCBP must be referred to a qualified provider of contraceptive methods if needed. Also, FCBP must have a pregnancy check with a negative serum pregnancy test obtained 28 days prior to and confirmed by C1D1.
- Men must agree to use a condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy 1) while participating in the study; and 2) for at least 1 week following the last dose of zanubrutinib.
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥500/mcL believed to be caused by WM bone marrow involvement. Growth factors are not permitted <14 days prior to C1D1.
- Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted <14 days prior to C1D1.
- Hemoglobin ≥ 7 g/dL. RBC transfusions are not permitted <14 days prior to C1D1.
- Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases
- Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula
- Able to adhere to the study visit schedule and other protocol requirements.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
- Participants with known CNS involvement by WM
- Participants with known history of Human Immunodeficiency Virus (HIV)
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
- Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.
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- Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.
- Concurrent systemic immunosuppressant therapy. Systemic steroids at doses <20mg prednisone per day are permitted.
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Concurrent administration of warfarin or warfarin derivatives.
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
- Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.
- Major surgery within 4 weeks of first dose of study drug.
- History of severe bleeding disorder such as hemophilia A, hemophilia B, or history of spontaneous bleeding requiring blood transfusion or other medical intervention. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- Participants with inability to swallow pills.
- Inability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of the study participation.
- Any uncontrolled or significant cardiovascular disease defined as:
- Unstable angina within 3 months before screening, or
- History of myocardial infarction within 6 months prior to planned start of zanubrutinib, or
- Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of zanubrutinib; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during Screening should be performed in selected patients as medically indicated, or
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
- Uncontrolled or symptomatic arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- Participants with a known hypersensitivity to any of the excipients of Zanubrutinib, Rituximab, or Bendamustine.
- Participants with a history of non-compliance to medical regimens, which will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancers.
- Severe or debilitating pulmonary disease.
- Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.
- Ongoing use of a strong CYP3A inducer.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Andrew Branagan, MD, PhD, 617-724-4000, abranagan@mgh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gottfried Von Keudell, MD, 617-667-7000
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Shayna Sarosiek, MD, 617-632-3000, Shayna_Sarosiek@DFCI.HARVARD.EDU
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Larry D Anderson, MD, PhD, 214-648-4155, Larry.anderson@utsouthwestern.edu
- Recruiting
Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, 80218
Jeffrey V. Matous, MD, 720-754-4800, Jeffrey.Matous@HealthONECares.com
About this study
Official title: A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM).
The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.
Read the detailed description
This is multi-center phase 2 of zanubrutinib, bendamustine, and rituximab (ZBR) in previously untreated Waldenström macroglobulinemia (WM).
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved bendamustine and rituximab for your specific disease, but it has been approved for other uses.
The U.S. FDA has approved zanubrutinib as a treatment option for your disease.
The combination of zanubrutinib, bendamustine, and rituximab is not approved regimen for Waldenström macroglobulinemia (WM) and is investigational in this study.
Participation is expected for a maximum of 15 cycles and follow-up for up to 5 years.
It is expected that about 50 people will take part in this research study.
- Conditions
- Waldenstrom Macroglobulinemia
- Being tested
- Zanubrutinib, Bendamustine, Rituximab
- Keywords
- MW, Untreated
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111
A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor
BendamustineDrug
Alkylating agent
RituximabDrug
Monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib + Bendamustine + Rituximab | Experimental | Zanubrutinib will be taken orally once daily on days 1-28 of cycles 1-15.
Bendamustine will be given by intravenous infusion over about 10 to 60 minutes on days 1 and 2 of cycles 1 to 4.
Rituximab will be given by intravenous infusion over about 30 minutes on day 1 of cycles 1 to 4.
Drug diaries will be provided to participants to document information about the study treatment being taken. Receives: Drug: Zanubrutinib; Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very Good Partial Response (VGPR) or Better Response Rate
Assessed using 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants will be gauged for very good partial response (VGPR) rate or better.
Measured: Day 1 to 5 years post treatment
Secondary outcomes (9)
Treatment Related Adverse Events
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All participants will be followed and assessed for safety and tolerability of the protocol therapy.
Measured: Day 1 to 5 years post treatment
Overall Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR).
Measured: Day 1 to 5 years post treatment
Major Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for partial response (PR), very good partial response (VGPR), and complete response (CR).
Measured: Day 1 to 5 years post treatment
Complete Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for having resolution of Waldenstrom's Macroglobulinemia (WM) related symptoms, normalization of serum Immunoglobulin M (IgM) levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A complete response requires reconfirmation demonstrating normal serum IgM levels, and absence of IgM paraprotein by immunofixation by a measurement repeated at least 2 weeks later.
Measured: Day 1 to 5 years post treatment
Median Time to Response
All participants by mutational status will be assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria.
Measured: Day 1 to 5 years post treatment
Median Time to Major Response
All participants by mutational status will be assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria.
Measured: From Day 1 until date of major response is first documented, assessed up to 5 years post treatment
Median time to Next Treatment
The duration of time from the initiation of study treatment to the date of commencement of the next line of therapy.
Measured: From Day 1 until date of next line of therapy is first documented, assessed up to 5 years post treatment
Progression-Free Survival
The duration of time from start of treatment to time of objective disease progression or death. Median, 2-year and 4-year landmark progression free survival (PFS) analysis will be determined.
Measured: From Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years post treatment
Overall Survival
The duration of time from start of treatment to time of death or last follow-up. Median, 2-year and 4-year landmark overall survival (OS) analysis will be determined.
Measured: From Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start20 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines
- Responsible party
- Principal investigator, Andrew R. Branagan, M.D., Ph.D., Massachusetts General Hospital
- Investigators
- Andrew Branagan, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561347
- Sponsor's protocol ID
- 24-294
- Acronym
- ZEBRA
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)
- ClinicalTrials.gov ID
- NCT06561347
- Acronym / sponsor ID
- ZEBRA / 24-294
- Conditions
- Waldenstrom Macroglobulinemia
- Keywords
- MW, Untreated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- BeOne Medicines
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM).
The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.
Detailed description
This is multi-center phase 2 of zanubrutinib, bendamustine, and rituximab (ZBR) in previously untreated Waldenström macroglobulinemia (WM).
A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved bendamustine and rituximab for your specific disease, but it has been approved for other uses.
The U.S. FDA has approved zanubrutinib as a treatment option for your disease.
The combination of zanubrutinib, bendamustine, and rituximab is not approved regimen for Waldenström macroglobulinemia (WM) and is investigational in this study.
Participation is expected for a maximum of 15 cycles and follow-up for up to 5 years.
It is expected that about 50 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib + Bendamustine + Rituximab | Experimental | Drug: Zanubrutinib, Drug: Bendamustine, Drug: RituximabZanubrutinib will be taken orally once daily on days 1-28 of cycles 1-15. Bendamustine will be given by intravenous infusion over about 10 to 60 minutes on days 1 and 2 of cycles 1 to 4. Rituximab will be given by intravenous infusion over about 30 minutes on day 1 of cycles 1 to 4. Drug diaries will be provided to participants to document information about the study treatment being taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria
- Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type
- Meeting criteria for treatment per IWWM2 criteria. At least one of the following:
- Treatment naive; must have not received any prior systemic therapy for WM
- Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.
Key exclusion criteria (28 listed)
- Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form
- Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
- Participants with known CNS involvement by WM
- Participants with known history of Human Immunodeficiency Virus (HIV)
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
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 |
|---|---|---|
| ZanubrutinibAlso: BGB-3111A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor | Drug | Zanubrutinib + Bendamustine + Rituximab |
| BendamustineAlkylating agent | Drug | Zanubrutinib + Bendamustine + Rituximab |
| RituximabMonoclonal antibody | Drug | Zanubrutinib + Bendamustine + Rituximab |
Primary outcome
Very Good Partial Response (VGPR) or Better Response Rate
Time frame: Day 1 to 5 years post treatment
Assessed using 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants will be gauged for very good partial response (VGPR) rate or better.
9 secondary outcomes
Treatment Related Adverse Events
Time frame: Day 1 to 5 years post treatment
Overall Response Rate
Time frame: Day 1 to 5 years post treatment
Major Response Rate
Time frame: Day 1 to 5 years post treatment
Complete Response Rate
Time frame: Day 1 to 5 years post treatment
Median Time to Response
Time frame: Day 1 to 5 years post treatment
Median Time to Major Response
Time frame: From Day 1 until date of major response is first documented, assessed up to 5 years post treatment
Median time to Next Treatment
Time frame: From Day 1 until date of next line of therapy is first documented, assessed up to 5 years post treatment
Progression-Free Survival
Time frame: From Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years post treatment
Overall Survival
Time frame: From Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years post treatment
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 1 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Andrew Branagan, MD, PhD principal investigator
Massachusetts General Hospital
5 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 Zanubrutinib, Bendamustine and Rituximab in people with Waldenstrom Macroglobulinemia, run by Massachusetts General Hospital at 5 sites in United States.
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 31 inclusion and 28 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Andrew Branagan, MD, PhD (617-724-4000, abranagan@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Very Good Partial Response (VGPR) or Better Response Rate (time frame: Day 1 to 5 years post treatment). 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 1 Sep 2026.