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AzTrials

Ann Arbor Stage II Mantle Cell LymphomaPhase 1NCT07444710

Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma

A Phase 1 study testing Biospecimen Collection, Cisplatin and Computed Tomography in people with Ann Arbor Stage II Mantle Cell Lymphoma and Ann Arbor Stage III Mantle Cell Lymphoma, run by National Cancer Institute (NCI).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This phase I trial tests the safety, side effects and best dose of glofitamab given with alternating cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)/ rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP) for the treatment of mantle cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Biospecimen Collection, Cisplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
30 Dec 2026to 1 Sep 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed previously untreated mantle cell lymphoma which is stage II bulky, stage III, or stage IV and fit for intensive chemotherapy. TP53 mutated patients are eligible
  • Patients must exhibit measurable disease by PET or CT imaging with at least one site of disease > 1.5 cm in longest dimension or documented bone marrow involvement
  • Age ≥ 18 years to ≤ 75 years. Because no dosing or adverse event data are currently available on the use of glofitamab in combination with R-CHOP/R-DHAP in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 100,000/mcL
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  • Total bilirubin ≤ 2 × institutional upper limit of normal (ULN) unless total bilirubin elevation is attributable to Gilbert's syndrome or lymphomatous infiltration of the liver in whom total bilirubin must be < 3 times ULN
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN
  • Creatinine clearance ≥ 30 ml/min
  • Left ventricular ejection fraction ≥ 45% by echocardiogram or Multiple-Gated Acquisition (MUGA) scan
  • International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN in the absence of therapeutic anticoagulation
  • Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN in the absence of a lupus anticoagulant
  • Hemoglobin (Hgb) ≥ 8 g/dL
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
  • 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
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
  • The effects of glofitamab on the developing human fetus are unknown. For this reason and because glofitamab used in this trial is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 2 months after completion of glofitamab administration and 12 months after completion of rituximab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male participants with a female partner of childbearing potential or pregnant female partners must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 2 months after the final dose of glofitamab or 160 days after the final dose of rituximab. Male participants must refrain from donating sperm during this same period
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Who cannot join

  • Patients who received prior treatment for MCL, including chemotherapy, bispecific antibody therapy, or other cytotoxic or cellular therapy including autologous hematopoietic stem cell transplant (autoHCT). Since this study aims to evaluate safety and efficacy in previously untreated patients by using this regimen as a first-line therapy, prior systemic therapy would potentially bias and affect endpoints and results
  • Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Patients who are receiving any other investigational agents
  • Patients with lymphoma that shows active and uncontrolled CNS involvement; uncontrolled CNS involvement may require different systemic therapy in addition to CNS directed therapy, which would interfere with the study regimen and sequence of drug administration
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab or other agents used in study
  • Patients with active, uncontrolled infection defined as ongoing signs or symptoms of infection despite antimicrobial therapy or other infection-directed therapy
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  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous
  • Pregnant women are excluded from this study because glofitamab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glofitamab, breastfeeding should be discontinued if the mother is treated with glofitamab. These potential risks may also apply to other agents used in this study
  • Patients with prior solid organ transplantation
  • Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anticytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter
  • Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of cycle 1
  • Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of cycle 1
  • Prior radiotherapy to the mediastinal/pericardial region. Radiotherapy to non-target lesion sites will be permitted
  • Corticosteroid use > 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control.
  • Participants receiving corticosteroid treatment with ≤ 50 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of cycle 1.
  • Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted.
  • The use of inhaled corticosteroids is permitted.
  • The use of mineralocorticoids for management of orthostatic hypotension is permitted.
  • The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.
  • Participants who require lymphoma symptom control during screening may receive steroids in the following manner:
  • Up to 50 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).
  • If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of >30-100 mg/day of prednisone or equivalent. Prednisone > 30-100 mg/day or equivalent may be given for a maximum of 10-14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered
  • Patients who had a recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis
  • Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Patients with current or past history of Waldenström macroglobulinemia
  • Patients with known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, SARS-Cov-2, Epstein Barr virus [EBV], known or suspected chronic active EBV [CAEBV], cytomegalovirus [CMV]), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing
  • History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:
  • Grade ≥ 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy.
  • Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
  • Participants with autoimmune disease that is controlled or not currently active (i.e., distant history of Guillain-Barré syndrome that has resolved) may be eligible for this study.
  • Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
  • Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.
  • Participants with controlled Type I diabetes mellitus who are on an insulin regimen are eligible for the study
  • • Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible (e.g., participants with psoriatic arthritis are excluded) if all the following conditions are met:
  • Rash covers < 10% of body surface area.
  • Disease is well controlled for the last 12 months and requires only low potency topical corticosteroids
  • Patients with clinically significant liver disease, including active viral or other hepatitis or cirrhosis
  • Live, attenuated vaccine within 4 weeks before study treatment infusion on day 1 of cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited. Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period
  • Patients with suspected active or latent tuberculosis (as confirmed by a positive interferon gamma release assay
  • Patients with a history of progressive multifocal leukoencephalopathy

About this study

Official title: A Phase I Study of Glofitamab With Alternating R-CHOP/R-DHAP in Previously Untreated Mantle Cell Lymphoma

This phase I trial tests the safety, side effects and best dose of glofitamab given with alternating cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)/ rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP) for the treatment of mantle cell lymphoma. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody 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). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone and dexamethasone are in a class of medications called corticosteroids. They are used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Chemotherapy drugs, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Giving glofitamab may be safe, tolerable and/or effective in treating patients with mantle cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of the combination of glofitamab and alternating cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)/ rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP) as defined by the incidence and severity of adverse events (AEs) and/or dose limiting toxicity (DLT) related to glofitamab and/or chemo-immunotherapy in patients with previously untreated mantle cell lymphoma (MCL).

II. To determine the recommended phase II dose (RP2D) for the combination of glofitamab and R-CHOP/R-DHAP.

SECONDARY OBJECTIVES:

  1. To observe and record anti-tumor activity. II. To determine the tolerability of the study treatment as measured by dose interruptions, dose reductions, and treatment discontinuation due to AEs and DLTs.

III. To determine the overall response rate (ORR) after induction therapy and after maintenance therapy, complete response rate (CRR), and partial response rate (PRR) based on positron emission tomography (PET)/ computed tomography (CT) according to the 2014 Lugano Response Criteria.

IV. To assess failure-free survival and overall survival.

EXPLORATORY OBJECTIVES:

  1. To evaluate minimum-residual disease (MRD)-negative CRR after completion of induction therapy, and after year(s) 1 and 2 of maintenance glofitamab therapy.

II. To determine the rates of dose delays or discontinuation of therapy, cytopenias, and occurrence of grade 3 or higher infections during glofitamab maintenance therapy.

OUTLINE: This is a dose-escalation study of glofitamab in combination with alternating doses of R-CHOP and R-DHAP followed by a dose-expansion study.

INDUCTION:

CYCLES: 1, 3 and 5: Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, as well as prednisone orally (PO) on days 1-5. Starting with cycle 3, patients also receive glofitamab IV, over 2-8 hours, on day 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

CYCLES 2, 4 and 6: Patients receive rituximab IV, and cisplatin IV over 24 hours on day 1, as well as cytarabine IV on day 2 and dexamethasone PO on days 1-4. Patients also receive glofitamab IV, over 2-8 hours, on days 8 and 15 of cycle 2 and on day 8 of subsequent cycles. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive glofitamab IV on day 1 of each cycle. Cycles repeat every 21 days for a total of 24 months of treatment, in the absence of disease progression or unacceptable toxicity.

Patients undergo positron emission tomography (PET)/computed tomography (CT) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Being tested
Biospecimen Collection, Cisplatin, Computed Tomography, Cyclophosphamide, Cytarabine

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

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

    Undergo CT scan

  • 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

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IV

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Given IV

  • GlofitamabBiological

    Also called Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody RO7082859, Columvi, Glofitamab-gxbm, RO 7082859

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

  • RituximabBiological

    Also called ABP 798, ABP-798, ABP798, BI 695500

    Given IV

  • VincristineDrug

    Also called LCR, Leurocristine, VCR, Vincrystine

    Given IV

Study groups in NCT07444710
Study groupRoleWhat they receive
Treatment (glofitamab with R-CHOP/R-DHAP)ExperimentalINDUCTION: CYCLES: 1, 3 and 5: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, as well as prednisone PO on days 1-5. Starting with cycle 3, patients also receive glofitamab IV, over 2-8 hours, on day 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 2, 4 and 6: Patients receive rituximab IV, and cisplatin IV over 24 hours on day 1, as well as cytarabine IV on day 2 and dexamethasone PO on days 1-4. Patients also receive glofitamab IV, over 2-8 hours, on days 8 and 15 of cycle 2 and on day 8 of subsequent cycles. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive glofitamab IV on day 1 of each cycle. Cycles repeat every 21 days for a total of 24 months of treatment, in the absence of disease progression or unacceptable toxicity.
Receives: Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin; Biological: Glofitamab; Procedure: Positron Emission Tomography; Drug: Prednisone; Biological: Rituximab; Drug: Vincristine

What is being measured

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

  1. Incidence of adverse events (AEs)

    Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 for all AEs other than cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), and hemophagocytic lymphohistiocytosis (HLH). CRS, ICANS, and HLH will be graded according to American Society for Transplantation and Cellular Therapy criteria.

    Measured: Up to 5 years

  2. Dose limiting toxicity (DLT)

    DLT is defined as any grade 4 or higher CRS event, any grade CRS event that does not improve to < grade 2 within 72 hours, any grade 3 or higher neurologic toxicity event including ICANS events, any grade 3 or higher non-hematologic toxicity, grade 3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation that does not resolve to grade 2 or less within 14 days, grade 4 AST or ALT is a DLT regardless of duration, grade 4 thrombocytopenia lasting more than 7 days, grade 3 thrombocytopenia with hemorrhage, grade 3 thrombocytopenia lasting ≥ 28 days or grade 4 neutropenia lasting ≥ 14 days despite the use of growth factors.

    Measured: From cycle 2, day 8 to cycle 5 day 1 (cycle length = 21 days)

Secondary outcomes (5)

  1. Overall response rate

    Will be analyzed, based on positron emission tomography (PET)/computed tomography (CT) according to 2014 Lugano Response Criteria.

    Measured: From completion of induction therapy, up to 5 years

  2. Complete response rate

    Will be analyzed, based on PET/CT according to 2014 Lugano Response Criteria.

    Measured: Up to 5 years

  3. Partial response rate

    Will be analyzed, based on PET/CT according to 2014 Lugano Response Criteria.

    Measured: Up to 5 years

  4. Failure free survival

    Measured: From enrollment to stable disease at the end of induction therapy, progressive disease, or death from any cause, up to 5 years

  5. Overall survival

    Measured: From enrollment to death from any cause, up to 5 years

Timeline

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

  1. First posted3 Mar 2026
  2. Study start30 Dec 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07444710
Sponsor's protocol ID
NCI-2026-01137
Other IDs
NCI-2026-01137, PHI-158, 10760, 10760, UM1CA186717
Status last verified
Nov 2026
First submitted
28 Feb 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Cisplatin and Computed Tomography in people with Ann Arbor Stage II Mantle Cell Lymphoma and Ann Arbor Stage III Mantle Cell Lymphoma, run by National Cancer Institute (NCI).

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 41 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Incidence of adverse events (AEs) (time frame: Up to 5 years). The study lists 2 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 NCT07444710.

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 6 Nov 2026.

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