CNS LymphomaPhase 1NCT06730542
Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
A Phase 1 study testing Zanubrutinib, Methotrexate and Polatuzumab Vedotin in people with CNS Lymphoma, run by Juan P. Alderuccio, MD at 1 site in United States.
Trial summary
The purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- Zanubrutinib, Methotrexate and Polatuzumab Vedotin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 30 Apr 2030
- Phase
- Phase 1
- 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
- Men and women ≥ 18 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Patients must have histologic confirmation of large B-cell lymphoma (LBCL) defined by the World Health Organization (WHO) classification. All LBCL subtypes are acceptable. Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy.
- Baseline 18-fluorodeoxyglucose (FDG)-positron emission tomography scan/computed tomography (PET/CT) must demonstrate FDG avid lesions compatible with CT-defined anatomical tumor sites (Note: FDG-PET/CT is not mandatory, and patients with CT scans only will be eligible for study entry as well). Patients should have at least 1 measurable site of disease per Lugano classification in FDG-PET/CT or CT scans.
- Presence of systemic and CNS involvement (brain, cerebellum, brainstem, meninges, cranial nerves, eyes, spinal cord, or a combination of these) at presentation.
- Determination of CNS involvement can be by brain biopsy, cerebrospinal fluid (CSF) evaluation by cytology and/or flow cytometry, neuroimaging, or strong clinical suspicion by Investigator for which CNS targeted therapy is recommended (ie, numb chin syndrome in patients with high CNS involvement risk).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2, except due to lymphoma involvement.
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- Life expectancy of greater than ≥ 3 months.
- Women should avoid becoming pregnant while taking zanubrutinib and for up to 90 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking zanubrutininb and for up to 90 days after stopping treatment. It is currently unknown whether zanubrutinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method. Pregnancy testing is recommended for women of reproductive potential prior to initiating therapy.
- Agreement to use contraception during study participation.
- Female patients of childbearing potential must use highly effective methods of contraception. Recommended acceptable contraception methods are included in Section 5.12.
- Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.
- A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.
- Male patients with a female partner of childbearing potential are eligible if they abstained, are vasectomized or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for 90 days after the last dose of zanubrutinib.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) > 1,000 cells/mm3 independent of growth factor support within 7 days of study entry (≥ 750 cells/mm3 if lymphoma involvement of the bone marrow or spleen).
- Platelets ≥ 75,000 platelets/mm3 independent of transfusion support within 7 days of study entry (≥ 50,000/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone marrow or spleen).
- Hemoglobin > 9 g/dL or > 8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.
- Serum total bilirubin ≤ 2 x upper limit of normal (ULN; except patients with Gilberts syndrome).
- Aspartate aminotransferase (AST; serum glutamic-oxaloacetic transaminase (SGOT)) and alanine transaminase (ALT); serum glutamic-pyruvic transaminase (SGPT)) ≤2.5 x institutional ULN (≤3x institutional ULN if lymphoma involvement of the liver).
- Creatinine within normal institutional limits, or creatinine clearance ≥ 40 mL/min (as estimated by the Cockcroft-Gault equation or alternative formula according to institutional guidelines) for patients with creatinine levels above institutional normal.
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments (SoA).
Who cannot join
- Primary CNS lymphoma without evidence of systemic lymphoma.
- Prior systemic lymphoma therapy (Note: 1 cycle of an anthracycline based regimen, such as rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone (R-CHOP), polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP), dose-adjusted etoposide phosphate, prednisone, oncovin, cyclophosphamide, hydroxydaunorubicin, and rituximab (EPOCH-R), or rituximab, cyclophosphamide, vincristine, doxorubicin, and methotrexate (R-Codox-M), and/or 1 dose of intrathecal therapy, will be allowed before enrollment [Section 5.9]). Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy.
- Any uncontrolled or clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening;
- Unstable angina within 3 months before screening;
- New York Heart Association class III or IV congestive heart failure;
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- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- Uncontrolled hypertension as indicated by ≥ 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mm Hg and/or diastolic blood pressure > 105 mm Hg at screening.
- QT interval corrected with Fridericia's formula (QTcF) > 450 msec or other significant electrocardiogram (EKG) abnormalities, including second-degree atrioventricular block Type II or third-degree atrioventricular block.
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Uncontrolled intercurrent illness such as liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (> 10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness which would compromise ability to comply with study procedures.
- Severe or debilitating pulmonary disease.
- Concurrent malignancy requiring active therapy.
- 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 cancer.
- Active fungal, bacterial and/or viral infection requiring systemic therapy.
- Breastfeeding or pregnant women.
- Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
- Patients with positive HIV test and undetectable viral load will be eligible for this study.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation.
- Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable. For more information regarding hepatitis B and C testing, please refer to Section 9.2.5.4.
- Patients with impaired decision-making capacity.
- Ongoing treatment with medications that are strong cytochrome P450 (CYP), family 3, subfamily A (CYP3A) inducers.
- Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, stomach or small bowel resection, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- History of severe bleeding disorder, such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- History of stroke or intracranial hemorrhage within 180 days before the first dose of zanubrutinib.
- Major surgery within 4 weeks of the first dose of zanubrutinib. Major surgery is defined as open-heart, reconstructive, transplant, removal of a brain tumor or a damaged kidney surgery.
- The patient requires treatment with warfarin, warfarin derivatives, or other vitamin K antagonists.
- Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.
- Hypersensitivity to zanubrutinib, any components of pola-R-CHP, regimen, and/or high-dose (HD) methotrexate (MTX), or any of the other ingredients of the applicable study medications.
- Concurrent participation in another therapeutic clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Juan P Alderuccio, MD, +1 (347) 9312272, jalderuccio@med.miami.edu
Juan P Alderuccio, MD
About this study
The purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.
- Conditions
- CNS Lymphoma
- Being tested
- Zanubrutinib, Methotrexate, Polatuzumab Vedotin, Rituximab, Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Zanubrutinib capsules will be self-administered orally by participants at a starting dose of 160 mg twice a day (BID) or 320 mg once a day (QD)* at the beginning of Cycle 2 of Pola-R-CHP therapy.
MethotrexateDrug
Participants will receive Methotrexate as per standard of care (SOC).
Polatuzumab VedotinDrug
Participants will receive Polatuzumab Vedotin as per standard of care (SOC).
RituximabDrug
Participants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
CyclophosphamideDrug
Participants will receive Cyclophosphamide as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
DoxorubicinDrug
Participants will receive Doxorubicin as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
PrednisoneDrug
Participants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy.
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group | Experimental | Participants will be in this group for up to 2 years Receives: Drug: Zanubrutinib; Drug: Methotrexate; Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing dose-limiting toxicities (DLTs)
The number of participants experiencing dose-limiting toxicities (DLTs) after starting study therapy. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 21 days
Secondary outcomes (6)
Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the proportion of participants with complete response (CR) or partial response (PR) as the best response.
Measured: Up to 5 years
Number of Patients achieving conversion from PR to CR
Conversion from PR to CR will be assessed by the number of patients achieving an initial PR followed by how many will achieve a subsequent CR by Lugano response criteria.
Partial response (PR) will be calculated by a Deauville score of 4 or 5 with reduced uptake from baseline, and complete response (CR) is defined as a Deauville score of ≤ 3.
Measured: Up to 5 years
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the elapsed time in years from the start of treatment until disease progression or death, whichever is earlier. Participants who remain alive without progression will be censored at the last documented disease assessment date.
Measured: Up to 5 years
Overall Survival (OS)
Overall survival (OS) is defined as the elapsed time in years from the start of treatment until death from any cause. Alive participants will be censored at the last date known to be alive.
Measured: Up to 5 years
Number of participants experiencing treatment-related adverse events (AEs)
The number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 42 months
Number of participants experiencing treatment-related serious adverse events (SAEs)
The number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start17 Apr 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan P. Alderuccio, MD
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor-investigator, Juan P. Alderuccio, MD, University of Miami
- Investigators
- Juan P Alderuccio, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730542
- Sponsor's protocol ID
- 20240458
- Status last verified
- May 2026
- First submitted
- 9 Dec 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT06730542
- Acronym / sponsor ID
- 20240458
- Conditions
- CNS Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Juan P. Alderuccio, MDUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 12 Dec 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 is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group | Experimental | Drug: Zanubrutinib, Drug: Methotrexate, Drug: Polatuzumab Vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneParticipants will be in this group for up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Men and women ≥ 18 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Patients must have histologic confirmation of large B-cell lymphoma (LBCL) defined by the World Health Organization (WHO) classification. All LBCL subtypes are acceptable. Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy.
- Baseline 18-fluorodeoxyglucose (FDG)-positron emission tomography scan/computed tomography (PET/CT) must demonstrate FDG avid lesions compatible with CT-defined anatomical tumor sites (Note: FDG-PET/CT is not mandatory, and patients with CT scans only will be eligible for study entry as well). Patients should have at least 1 measurable site of disease per Lugano classification in FDG-PET/CT or CT scans.
- Presence of systemic and CNS involvement (brain, cerebellum, brainstem, meninges, cranial nerves, eyes, spinal cord, or a combination of these) at presentation.
- Determination of CNS involvement can be by brain biopsy, cerebrospinal fluid (CSF) evaluation by cytology and/or flow cytometry, neuroimaging, or strong clinical suspicion by Investigator for which CNS targeted therapy is recommended (ie, numb chin syndrome in patients with high CNS involvement risk).
Key exclusion criteria (31 listed)
- Primary CNS lymphoma without evidence of systemic lymphoma.
- Prior systemic lymphoma therapy (Note: 1 cycle of an anthracycline based regimen, such as rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone (R-CHOP), polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP), dose-adjusted etoposide phosphate, prednisone, oncovin, cyclophosphamide, hydroxydaunorubicin, and rituximab (EPOCH-R), or rituximab, cyclophosphamide, vincristine, doxorubicin, and methotrexate (R-Codox-M), and/or 1 dose of intrathecal therapy, will be allowed before enrollment [Section 5.9]). Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive anthracycline-based therapy.
- Any uncontrolled or clinically significant cardiovascular disease including the following:
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Uncontrolled intercurrent illness such as liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (> 10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness which would compromise ability to comply with study procedures.
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 |
|---|---|---|
| ZanubrutinibZanubrutinib capsules will be self-administered orally by participants at a starting dose of 160 mg twice a day (BID) or 320 mg once a day (QD)* at the beginning of Cycle 2 of Pola-R-CHP therapy. | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| MethotrexateParticipants will receive Methotrexate as per standard of care (SOC). | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| Polatuzumab VedotinParticipants will receive Polatuzumab Vedotin as per standard of care (SOC). | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| RituximabParticipants will receive Rituximab as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy. | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| CyclophosphamideParticipants will receive Cyclophosphamide as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy. | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| DoxorubicinParticipants will receive Doxorubicin as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy. | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
| PrednisoneParticipants will receive Prednisone as per standard of care (SOC), as part of combination standard of care Pola-R-CHP therapy. | Drug | Zanubrutinib in combination with Pola-R-CHP and in combination with Methotrexate Group |
Primary outcome
Number of participants experiencing dose-limiting toxicities (DLTs)
Time frame: Up to 21 days
The number of participants experiencing dose-limiting toxicities (DLTs) after starting study therapy. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 5 years
Number of Patients achieving conversion from PR to CR
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Number of participants experiencing treatment-related adverse events (AEs)
Time frame: Up to 42 months
Number of participants experiencing treatment-related serious adverse events (SAEs)
Time frame: Up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
Juan P Alderuccio, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zanubrutinib, Methotrexate and Polatuzumab Vedotin in people with CNS Lymphoma, run by Juan P. Alderuccio, MD at 1 site 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 22 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Juan P Alderuccio, MD (+1 (347) 9312272, jalderuccio@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing dose-limiting toxicities (DLTs) (time frame: Up to 21 days). 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 14 May 2026.