Post-transplant Lymphoproliferative DisorderPhase 1/2NCT06040320
Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
A Phase 1/2 study testing Polatuzumab vedotin, Rituximab and CHP in people with Post-transplant Lymphoproliferative Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will test polatuzumab vedotin in combination with rituximab in patients with treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate response rate of PTLD to single-agent rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Lymphoproliferative Disorder
- What is being tested?
- Polatuzumab vedotin, Rituximab and CHP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 31 May 2032
- Phase
- Phase 1/2
- 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
- Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder (or CD20-positive lymphoma associated with immune deficiency) arising after solid organ or hematopoietic stem cell transplant. This may be defined by either the 2016 World Health Organization classification of lymphoid neoplasms or the 2022 International consensus Classification of Mature Lymphoid Neoplasms or the 2022 World Health Organization classification.
- At least 18 years of age.
- ECOG performance status ≤ 3.
- Adequate hematologic and organ function (unless due to underlying lymphoma per the investigator) as defined below:
- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 75 K/cumm
Show all 16Show fewer
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin < 1.5 x IULN
- AST(SGOT)/ALT(SGPT) < 2.5 x IULN
- Creatinine clearance > 30 mL/min measured or by Cockcroft-Gault
- Note: Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias may be enrolled if the following criteria are met:
- ANC ≥ 0.5 K/cumm
- Platelets ≥ 50 K/cumm
- Hemoglobin ≥ 7.0 g/dL
- The effects of polatuzumab vedotin and rituximab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect pregnancy while participating in this study, the participant must inform the treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- Active central nervous system involvement with lymphoma / PTLD.
- Current grade ≥ 2 peripheral neuropathy.
- Current ejection fraction < 40% on transthoracic echocardiogram or multigated acquisition (MUGA) scan
- Subjects with history of concurrent second cancers requiring active, ongoing systemic treatment with the following exceptions:
- Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will not be excluded.
- Patients with previous malignancies are eligible if disease-free for > 2 years.
Show all 22Show fewer
- Patients on long term hormonal therapy to prevent recurrence of a prior cancer (e.g., hormonal therapy for breast cancer) will not be excluded.
- Currently receiving any other investigational agents or received any investigational agents during the 4 weeks prior to the first dose of polatuzumab vedotin.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to polatuzumab vedotin, rituximab, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, fungal, viral, parasitic, or mycobacterial), interstitial lung disease, active non-infectious pneumonitis, congestive heart failure NYHA grade ≥ 3, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to C1D1
- Patients with HIV are eligible provided the meet the following criteria:
- On antiretroviral regimen and stable on that regimen
- Healthy from an HIV perspective
- CD4 count > 250 cells/mcL
- Minimal anticipated interactions or overlapping toxicity with polatuzumab vedotin or rituximab
- HIV viral load < 200 copies/mm3 by standard clinical assays
- Active hepatitis B infection.
- Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation.
- Active hepatitis C infection.
- Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation.
- 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
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I/II Study of Frontline Therapy With Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
This study will test polatuzumab vedotin in combination with rituximab in patients with treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate response rate of PTLD to single-agent rituximab. The hypothesis is that this combination therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be explored as prognostic markers in PTLD.
- Being tested
- Polatuzumab vedotin, Rituximab, CHP
- Keywords
- PTLD, Non-Hodgkin's lymphoma, Risk stratification, Front-line
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab vedotinDrug
Also called Polivy
Given at 1.8 mg/kg
RituximabDrug
Also called Rituxan
Given at 375 mg/m^2
CHPDrug
Cyclophosphamide (750 mg/m^2) + doxorubicin (50 mg/m^2) + prednisone (100 mg days 2-6)
| Study group | Role | What they receive |
|---|---|---|
| Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission) | Experimental | * Cycle 1 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* Day 8: rituximab
* Day 15: rituximab
* Cycle 2 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total). Receives: Drug: Polatuzumab vedotin; Drug: Rituximab |
| Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission) | Experimental | * Cycle 1 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* Day 8: rituximab
* Day 15: rituximab
* Cycle 2 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total). Receives: Drug: Polatuzumab vedotin; Drug: Rituximab |
| Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission)) | Experimental | * Cycle 1 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* Day 8: rituximab
* Day 15: rituximab
* Cycle 2 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total). Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: CHP |
| Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission) | Experimental | * Cycle 1 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* Day 8: rituximab
* Day 15: rituximab
* Cycle 2 (21 days)
* Day 1: polatuzumab vedotin + rituximab
* After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total). Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: CHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-related adverse events (AEs)
Measured: From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months)
Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)
A dose-limiting toxicity (DLT) is defined as an occurrence of an adverse event delineated by the protocol that is at least possibly related to polatuzumab vedotin, rituximab, or the combination within Cycle 1 or Cycle 2.
Measured: From start of treatment through cycle 2 (estimated to be 42 days, each cycle is 21 days)
Rate of completion of the regimen
Measured: Through completion of treatment (estimated to be 4-6 months)
Secondary outcomes (7)
Complete metabolic response (CR) rate by PET/CT
-Per Lugano Response Criteria
Measured: After cycle 2 (estimated to be day 42, each cycle is 21 days)
Complete metabolic response (CR) rate by PET/CT
-Per Lugano Response Criteria
Measured: End of treatment (estimated to be between 4-6 months)
Overall response rate (ORR)
- Per Lugano Response Criteria
- Overall Response Rate: The proportion of patients who have a complete or partial response to therapy.
Measured: End of treatment (estimated to be between 4-6 months)
Best overall response
- Per Lugano Response Criteria
- Best Overall Response: Best response recorded from start of treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
Measured: Through completion of treatment (estimated to be between 4-6 months)
Duration of response
- Per Lugano Response Criteria
- Duration of Response: The time from onset of response to disease progression or death in patients who achieve complete or partial response.
Measured: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
Progression-free survival (PFS)
- Per Lugano Response Criteria
- Progression-Free Survival: The time from initiation of treatment to the occurrence of disease progression or death.
Measured: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
Overall survival (OS)
-Overall Survival: The time from initiation of treatment to death.
Measured: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start4 Oct 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Mehta-Shah, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040320
- Sponsor's protocol ID
- 202308116
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2023
- Last updated
- 30 Jun 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Frontline Therapy With Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)
- ClinicalTrials.gov ID
- NCT06040320
- Acronym / sponsor ID
- 202308116
- Keywords
- PTLD, Non-Hodgkin's lymphoma, Risk stratification, Front-line
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2032 (estimated)
- First posted
- 15 Sep 2023 (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.
This study will test polatuzumab vedotin in combination with rituximab in patients with treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate response rate of PTLD to single-agent rituximab. The hypothesis is that this combination therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be explored as prognostic markers in PTLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission) | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab* Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total). |
| Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission) | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab* Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total). |
| Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission)) | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: CHP* Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total). |
| Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission) | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: CHP* Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder (or CD20-positive lymphoma associated with immune deficiency) arising after solid organ or hematopoietic stem cell transplant. This may be defined by either the 2016 World Health Organization classification of lymphoid neoplasms or the 2022 International consensus Classification of Mature Lymphoid Neoplasms or the 2022 World Health Organization classification.
- At least 18 years of age.
- ECOG performance status ≤ 3.
- Adequate hematologic and organ function (unless due to underlying lymphoma per the investigator) as defined below:
- Note: Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias may be enrolled if the following criteria are met:
Key exclusion criteria (22 listed)
- Active central nervous system involvement with lymphoma / PTLD.
- Current grade ≥ 2 peripheral neuropathy.
- Current ejection fraction < 40% on transthoracic echocardiogram or multigated acquisition (MUGA) scan
- Subjects with history of concurrent second cancers requiring active, ongoing systemic treatment with the following exceptions:
- Currently receiving any other investigational agents or received any investigational agents during the 4 weeks prior to the first dose of polatuzumab vedotin.
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 |
|---|---|---|
| Polatuzumab vedotinAlso: PolivyGiven at 1.8 mg/kg | Drug | Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission), Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission), Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission), Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission)) |
| RituximabAlso: RituxanGiven at 375 mg/m^2 | Drug | Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission), Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission), Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission), Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission)) |
| CHPCyclophosphamide (750 mg/m^2) + doxorubicin (50 mg/m^2) + prednisone (100 mg days 2-6) | Drug | Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission), Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission)) |
Primary outcome
Frequency and severity of treatment-related adverse events (AEs)
Time frame: From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months)
Number of dose-limiting toxicities (DLTs) (Safety Lead-In Cohort only)
Time frame: From start of treatment through cycle 2 (estimated to be 42 days, each cycle is 21 days)
A dose-limiting toxicity (DLT) is defined as an occurrence of an adverse event delineated by the protocol that is at least possibly related to polatuzumab vedotin, rituximab, or the combination within Cycle 1 or Cycle 2.
Rate of completion of the regimen
Time frame: Through completion of treatment (estimated to be 4-6 months)
7 secondary outcomes
Complete metabolic response (CR) rate by PET/CT
Time frame: After cycle 2 (estimated to be day 42, each cycle is 21 days)
Complete metabolic response (CR) rate by PET/CT
Time frame: End of treatment (estimated to be between 4-6 months)
Overall response rate (ORR)
Time frame: End of treatment (estimated to be between 4-6 months)
Best overall response
Time frame: Through completion of treatment (estimated to be between 4-6 months)
Duration of response
Time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
Progression-free survival (PFS)
Time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 months)
Overall survival (OS)
Time frame: Through 5 years from completion of treatment (estimated to be between 64 and 66 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 30 Jun 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Neha Mehta-Shah, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polatuzumab vedotin, Rituximab and CHP in people with Post-transplant Lymphoproliferative Disorder, run by Washington University School of Medicine 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 16 inclusion and 22 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 30 Jun 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 combined 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.
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?
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?
Frequency and severity of treatment-related adverse events (AEs) (time frame: From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months)). The study lists 3 primary outcomes in all. 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 30 Jun 2026.