AzTrials
AzTrials

Acute Lymphoblastic LeukemiaPhase 2NCT06815003

Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning

A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Biopsy in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
18 Apr 2025to 15 Oct 2028
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Age: ≥ 18 and ≤ 80 years old
  • Note: Patients > 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2
Show all 34Show fewer
  • Karnofsky performance status ≥ 70%
  • Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8/8 match related/unrelated donor (A, B, C, DR by high resolution typing)
  • Acute Leukemias (acute myeloid leukemia [AML] or acute lymphoblastic leukemia [ALL]) in complete remission with bone marrow (BM) blast of < 5%
  • Myelodysplastic syndrome (blast < 10%)
  • Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT
  • Chronic myelomonocytic leukemia (CMML)
  • Hemoglobin ≥ 9g/dL (within 30 days prior to day 1 of protocol therapy)
  • NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
  • Total bilirubin ≤ 2.0 mg/dL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)
  • Aspartate aminotransferase (AST) =< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
  • Alanine aminotransferase (ALT) =< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
  • Creatinine clearance of ≤ 1.5 mg/dL or ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Note: To be performed within 28 days prior to day 1 of protocol therapy
  • IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)
  • Note To be performed within 28 days prior to day 1 of protocol therapy
  • IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation > 92% on room air
  • Note To be performed within 28 days prior to day 1 of protocol therapy
  • Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Tuberculosis test (within 30 days prior to day 1 of protocol therapy)
  • Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results
  • Meets other institutional and federal requirements for infectious disease titer requirements
  • Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  • Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • Prior allogeneic HCT
  • Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
  • Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded
  • Other investigational drugs for GVHD prophylaxis
  • Herbal medications
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Show all 13Show fewer
  • Clinically significant uncontrolled illness
  • Active infection not responding to antibiotics
  • Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Females only: Pregnant or breastfeeding
  • Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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

  • City of Hope Medical Center

    Duarte, California, 91010

    Monzr M. Al Malki, 626-218-2405, malmalki@coh.org

    Monzr M. Al Malki

    Recruiting

Other trials in United States

About this study

Official title: Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the safety and describe the toxicity profile of adding vedolizumab at a fixed dose level to post-transplant cyclophosphamide (PTCy) -based graft-versus-host disease (GVHD) prophylaxis with tacrolimus after mobilized peripheral blood stem cell (PBSC) allogeneic hematopoietic cell transplantation (HCT) from a matched related/unrelated donor. (Safety lead-in segment) II. Assess the efficacy of vedolizumab in combination with PTCy by grade 2-4 acute GVHD-free survival by day+180 after allogeneic hematopoietic cell transplantation (HCT). (Expansion segment)

SECONDARY OBJECTIVES:

  1. Continue safety assessment of vedolizumab + PTCy combination as GVHD prophylaxis in the expansion cohort.

II. Estimate overall survival (OS), progression-free survival (PFS), cumulative incidences of relapse/disease progression, and non-relapse mortality (NRM) at 100 days, and 1-year post-transplant.

III. Estimate rates of acute GVHD (day 100 and 180 post-HCT), lower gastrointestinal (GI) GVHD (day 100 and day 180 post-HCT), chronic GvHD (1-year post-HCT), infections (100 and 180 days and 1 year post HCT).

IV. Estimate rates of complete remission, and neutrophil recovery. V. Evaluate and describe the cytokine release syndrome (CRS) post-HCT by assessing the incidence, frequency, and severity of CRS.

EXPLORATORY OBJECTIVES:

  1. Donor cell engraftment will be assessed by count monitoring and short tandem repeat (STR) chimerism analysis on days +30 and day +100.

II. Describe the kinetics of immune cell recovery. III. Evaluate patient's quality of life on day +100, 6 months and one-year post-HCT.

IV. Describe the kinetics of GVHD biomarkers, and inflammatory cytokines for up to 100 days post-HCT.

  1. Obtain a preliminary estimate of gut microbiome diversity at baseline (preferably before fludarabine administration), and then on days +14, +30, +60, +100, and +180 after HCT.

OUTLINE:

Patients receive reduced intensity conditioning with fludarabine intravenously (IV) on days -7 to -3 and melphalan IV on day -2. Patients then undergo allogeneic HCT on day 0. Patients also receive vedolizumab IV over 30 minutes on days -1, +13, +41, +69, +97, +125, and +153, cyclophosphamide IV on days +3 and +4, and tacrolimus IV or orally (PO) on day +5 to day +95 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) and echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening, blood sample collection on study, and bone marrow biopsy throughout the study.

After completion of study treatment, patients are followed up at 30 days after the last dose of vedolizumab, day +180 and at 1 year.

Being tested
Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Graft vs Host Disease, Myelodysplastic Syndromes, Myeloproliferative Disorders

What participants receive

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

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC

    Undergo allogeneic HCT

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518

    Given IV

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • FludarabineDrug

    Also called Fluradosa

    Given IV

  • MelphalanDrug

    Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard

    Given IV

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Questionnaire AdministrationOther

    Ancillary studies

  • TacrolimusDrug

    Also called FK 506, FK-506, FK506, Fujimycin

    Given IV or PO

  • VedolizumabBiological

    Also called Entyvio, Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer's patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer, LDP 02, LDP-02

    Given IV

Study groups in NCT06815003
Study groupRoleWhat they receive
Prevention (vedolizumab, cyclophosphamide, tacrolimus)ExperimentalPatients receive reduced intensity conditioning with fludarabine IV on days -7 to -3 and melphalan IV on day -2. Patients then undergo allogeneic HCT on day 0. Patients also receive vedolizumab IV over 30 minutes on days -1, +13, +41, +69, +97, +125, and +153, cyclophosphamide IV on days +3 and +4, and tacrolimus IV or PO on day +5 to day +95 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and ECHO or MUGA during screening, blood sample collection on study, and bone marrow biopsy throughout the study.
Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography; Drug: Fludarabine; Drug: Melphalan; Procedure: Multigated Acquisition Scan; Other: Questionnaire Administration; Drug: Tacrolimus; Biological: Vedolizumab

What is being measured

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

  1. Incidence of primary engraftment failure (Safety lead-in segment)

    Will be assessed as an unacceptable toxicity (UT). Will include type, severity, duration, and attribution/association with the study regimen and dose limiting toxicity (DLT) occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% confidence intervals (CIs) will be provided for each measure of toxicity/adverse events.

    Measured: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

  2. Incidence of severe infusion reaction (Safety lead-in segment)

    Will be assessed as a UT. Will assess severe infusion reactions, grade 4 per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, after receiving the 1st or 2nd dose of vedolizumab. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

    Measured: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

  3. Incidence of grade 4-5 adverse events (Safety lead-in segment)

    Will be assessed as a UT. Will assess grade 4-5 adverse events based on CTCAE v 5.0 probably or definitely attributable to vedolizumab. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

    Measured: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first

  4. Non-relapse mortality (NRM) (Safety lead-in segment)

    Will be assessed as a UT. Defined as death occurring in a patient from causes other than relapse or progression. Deaths from relapse/progression will be considered a competing risk. NRM will be censored at last follow-up if patients are alive and remain disease free. Will be analyzed using the Kaplan-Meier curves.

    Measured: From date of stem cell infusion until non-disease related death, assessed up to 1 year post-hematopoietic cell transplant (HCT)

  5. Incidence of grade 2-4 acute graft versus host disease (GVHD)-free survival

    Will be assessed among patients in the safety lead-in and dose expansion segments. Will be estimated using Kaplan-Meier curve.

    Measured: From start of HCT to first occurrence of grade 2-4 acute GVHD followed until day +180 or death from any cause, whichever occurs first, assessed up to 1 year post-HCT

Secondary outcomes (13)

  1. Incidence of adverse events (Expansion segment)

    Will be assessed using CTCAE v5.0. Will assess grade 4-5 adverse events probably or definitely attributable to study regiment by day +30 post-HCT and grade 3-5 adverse events probably or definitely attributed to study regimen by day +130 that are not UT. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

    Measured: From the start of first dose of vedolizumab to day +130 post-HCT

  2. Incidence of grade 3-5 adverse events at least probably attributable to vedolizumab, but not UT

    Will be assessed using CTCAE v5.0. Will include type, severity, duration, and attribution/association with the study regimen and DLT occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% CIs will be provided for each measure of toxicity/adverse events.

    Measured: Up to day +180 post-HCT

  3. Overall survival

    Patients are considered a failure for this endpoint if they die, regardless of cause. Will be censored at last follow-up if the last known status is alive. Will be analyzed using the Kaplan-Meier curves.

    Measured: From the day of stem cell infusion until death, assessed up to 1 year post-HCT

  4. Progression free survival

    Patients are considered a failure for this endpoint if they die (regardless of cause) or experience disease progression or relapse. Will be censored at last follow-up if patients are alive and remain disease free. Will be analyzed using the Kaplan-Meier curves.

    Measured: From the date of stem cell infusion to the date of death, disease relapse/progression, whichever occurs first, assessed up to 1 year post-HCT

  5. Relapse/progression rate

    Deaths without relapse/progression will be considered a competing risk. Surviving patients with no history of relapse/progression will be censored at time of last follow-up. Will be analyzed using the Kaplan-Meier curves.

    Measured: From day of stem cell infusion (day 0) to 1 year post-HCT

  6. NRM

    Defined as death occurring in a patient from causes other than relapse or progression. Deaths from relapse/progression will be considered a competing risk. NRM will be censored at last follow-up if patients are alive and remain disease free. Will be analyzed using the Kaplan-Meier curves.

    Measured: From date of stem cell infusion until non-disease related death, assessed up to 1 year post-HCT

  7. Incidence of acute GVHD

    Will be graded and staged according to Mount Sinai Acute GVHD International Consortium (MAGIC) criteria. The first day of acute GVHD onset at a certain grade will be used to calculate the cumulative incidence (grades II-IV). Will be evaluated among all patients treated with study regimen. Will be estimated using Kaplan-Meier curve.

    Measured: From day 0 to days +100 and +180 post-HCT

  8. Incidence of lower gastrointestinal GVHD

    Will be graded and staged according to MAGIC criteria. The first day of acute GVHD onset at a certain grade will be used to calculate the cumulative incidence (grades II-IV). Will be evaluated among all patients treated with study regimen. Will be estimated using Kaplan-Meier curve.

    Measured: From day 0 to days +100 and +180 post-HCT

  9. Incidence chronic GVHD

    Will be evaluated and scored according to National Institutes of Health Consensus Staging. The first day of chronic GVHD onset will be used to calculate the cumulative incidence. Will be evaluated among all patients treated with study regimen. Will be estimated using Kaplan-Meier curve.

    Measured: From day +80 post-HCT to 1 year post-HCT

  10. Incidence of infections

    Microbiologically documented infections will be reported by site of disease, date of onset, severity and resolution, if any.

    Measured: At days +100 and +180 post-HCT and 1 year post-HCT

  11. Hematologic recovery

    Will be defined as absolute neutrophil count (ANC) ≥ 0.5 x 10^3/μL achieved and sustained for 3 consecutive lab values on different days with no subsequent decline and platelets ≥ 20 K/μL independent of platelet transfusion support (date should reflect no transfusions in previous 7 days, and the first of 3 consecutive lab values on different days).

    Measured: Up to 1 year post-HCT

  12. Primary graft failure

    Will be defined as failure to achieve ANC of 500 or more for 3 days and, hypocellular marrow, and donor chimerism of < 5% all by day 28.

    Measured: Up to 28 days post-HCT

  13. Incidence of cytokine release syndrome

    Will be defined and graded per American Society for Transplantation and Cellular Therapy criteria.

    Measured: Up to 1 year post-HCT

Timeline

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

  1. First posted7 Feb 2025
  2. Study start18 Apr 2025
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion15 Oct 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06815003
Sponsor's protocol ID
24473
Other IDs
NCI-2025-00341, 24473, P30CA033572
Status last verified
Jun 2026
First submitted
4 Feb 2025
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection and Bone Marrow Biopsy in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by City of Hope Medical Center 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 34 inclusion and 13 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 29 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 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of primary engraftment failure (Safety lead-in segment) (time frame: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first). The study lists 5 primary outcomes in all. 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 NCT06815003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in