Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2APhase 1NCT03513484
Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing Azacitidine, Laboratory Biomarker Analysis and Nintedanib in people with Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A and Fibroblast Growth Factor Basic Form Measurement, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication
- What is being tested?
- Azacitidine, Laboratory Biomarker Analysis and Nintedanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESCLATION COHORT: Patients must have a diagnosis of newly diagnosed and/ or relapsed/refractory AML with any of the following:
- Confirmed translocation involving 11q23
- Partial tandem duplication(PTD) of the MLL gene (on 11q23)
- FLT3-ITD (internal tandem duplication)
- Increased Fgf2 in serum (2 standard deviations above control serum samples)
- HOX(A9/A10) over-expression in bone marrow ( 2 standard deviations above control values in CD34+ cells from normal subjects)
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- Note: Relapsed or refractory AML is defined as either:
- Recurrence of disease after a complete remission (CR), or
- Failure to achieve CR with initial therapy
- EXPANSION COHORT: Patients must have a diagnosis of newly diagnosed AML with any of the following:
- Confirmed translocation involving 11q23
- Partial tandem duplication (PTD) of the MLL gene (on 11q23)
- FLT3-ITD (internal tandem duplication)
- Increased Fgf2 in serum (2 standard deviations above control serum samples)
- HOX(A9/A10) over-expression in bone marrow (2 standard deviations above control values in CD34+ cells from normal subjects)
- Note: Patients with secondary AML are eligible for enrollment into the trial (in both cohorts); secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndromes (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML
- Patients who are not candidates for, or decline, intensive therapy
- Patients must exhibit an ECOG performance status 0-3
- International normalized ratio (INR) ? 2 (If coagulopathy is related to disease, this criterion does not apply) within14 days prior to registration
- Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 x of institutional upper limit of normal (ULN) (Note: If coagulopathy is related to disease, this criteria do not apply) within14 days prior to registration
- Total bilirubin ? 1.5 x of institutional ULN within14 days prior to registration
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) 1.5 X institutional upper limit of normal (ULN) within14 days prior to registration
- Creatinine 2 x ULN OR creatinine clearance > 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation
- Females of child-bearing potential (FOCBP) and males must agree to use medically acceptable method of contraception (e.g. a method which results in a low failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, latex condoms for participating males, sexual abstinence) prior to study entry, for the duration of study participation, and for 3 months following completion of therapy; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; if the female partner of a male participant becomes pregnant he should inform the treating physician and the female partner should contact her treating physician immediately
- NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- FOCBP must have a negative pregnancy test (beta-human chorionic gonadotropin [HCG] test in urine or serum) within 7 days prior to registration on study (Note: The test will have to be repeated if cycle 1 day1 is more than 3 days from registration)
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
- Patients must agree/be able to comply with all protocol specific requirements
Who cannot join
- Patients who have received chemo-, hormone-, radio or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 14 days prior to start of treatment or those who have not recovered from adverse events attributed to the agent to grade 1 or baseline
- Exceptions for prior treatments are:
- Hydroxyurea for increased blast count (no washout period required; it can be continued throughout the first cycle of therapy)
- Leukapheresis for leukocytosis (no wash out period required; it can be continued during the study)
- Note: If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration; please see assigned quality assurance monitor (QAM) with questions
- Patients who have received any other investigational product within14 days of treatment are not eligible for this study; a wash out period ? 14 days or 5 half- lives (whichever is greater) is required from investigational treatment, prior to start of study treatment; please Note:
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- If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration; please see assigned QAM with questions
- The ?5 half-lives? time period will be determined by investigational pharmacy
- If half life is not known and cannot be predicted, then wash out of ? 14 days is required
- Patients who have had major injuries and/or surgery within the past 4 weeks (< 28 days) prior to registration with incomplete wound healing and/or planned surgery while the patient is on study treatment
- Patients who have proteinuria CTCAE version (v)4.03 grade 2 or greater within < 30 days of registration
- Patients who have significant cardiovascular diseases are not eligible; these are:
- Uncontrolled hypertension
- Unstable angina
- History of infarction within the past 12 months prior to start of study treatment
- Congestive heart failure > New York Heart Association (NYHA) II
- Serious uncontrolled cardiac arrhythmia
- Pericardial effusion
- Patients requiring therapeutic anticoagulation with drugs requiring INR monitoring or anti-platelet therapy, except for acetylsalicylic acid (aspirin) ? 325 mg per day, are not eligible
- Patients with acute promyelocytic leukemia (APL) are not eligible
- Patients with known or suspected central nervous system (CNS) leukemia are not eligible
- Patients with known extramedullary leukemia are not eligible
- Patients who have received prior treatment with nintedanib or any other VEGFR inhibitor are not eligible
- Patients with known hypersensitivity to nintedanib or 5-azacitidine or who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nintedanib or 5-azacitidine are not eligible
- Patients with hypersensitivity to mannitol are not eligible; patients who have known hypersensitivity to peanut or soya, any other trial drug, or their excipients, or to contrast media are not eligible
- Patients with known active or history of chronic hepatitis C and/or B infection, known HIV infection and active alcohol or drug abuse are not eligible.
- Patient with HIV who require anti-viral or supportive care that interacts with the study drugs are not eligible
- Patients must not have a concurrent active malignancy for which they are receiving treatment
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Active uncontrolled infection
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastrointestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient?s safety or study endpoints
- Female patients who are pregnant or nursing are not eligible
- Patients who are unable to swallow oral gel capsules are not eligible
- Patients who have gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug are not eligible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib, Open Label, Combination Study of Nintedanib With 5-Azacitidine in Acute Myeloid Leukemia Characterized by HOX Gene Overexpression, That Are Not Candidates of Intensive Chemotherapy
The purpose of this study is to find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify maximum tolerated dose (MTD) of nintedanib for combination treatment of nintedanib and azacytidine (5-azacitidine) in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia with HOX overexpression and who are ineligible for intensive chemotherapy.
SECONDARY OBJECTIVES:
- Adverse events (AEs) including dose limiting toxicities (DLTs) will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
II. To determine median overall survival. III. To determine complete remission (CR) rate.
EXPLORATORY OBJECTIVES:
- To determine composite CR rate (CR + complete remission with incomplete platelet recovery [CRp] + complete remission with incomplete hematological recovery [Cri]).
II. To determine duration of confirmed response. III. To determine event free survival. IV. To determine leukemia free survival. V. To establish correlation between response and pre-treatment Fgf2 levels and change in Fgf-2 levels during treatment.
OUTLINE: This is a dose-escalation study of azacitidine.
Participants receive nintedanib orally (PO) twice daily (BID) on days 1-28 and azacitidine intravenously (IV) or subcutaneously (SC) on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks.
After completion of study treatment, participants are followed up at every 3 months for 12 months and then every 6 months for up to 24 months.
- Conditions
- Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication, Recurrent Adult Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Being tested
- Azacitidine, Laboratory Biomarker Analysis, Nintedanib
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC
Given IV or SC
Laboratory Biomarker AnalysisOther
Correlative studies
NintedanibDrug
Also called BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nintedanib, azacitidine) | Experimental | Participants receive nintedanib PO BID on days 1-28 and azacitidine IV or SC on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks. Receives: Drug: Azacitidine; Other: Laboratory Biomarker Analysis; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Will be defined as the highest dose that causes dose limiting toxicities (DLTs) in < 2 of 6 patients.
Measured: Up to 28 days
Secondary outcomes (3)
Incidence of adverse events
Adverse event assessments and laboratory tests will be performed at baseline, and continuously throughout the study at the beginning of each subsequent cycle.
Measured: Up to 24 months
Overall survival
Will be summarized using Kaplan-Meier curves. Median overall survival with 95% confidence interval will be calculated.
Measured: Up to 24 months
Complete remission (CR) rate
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start14 Nov 2018
- Primary completion11 Dec 2023
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2AStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center, Boehringer Ingelheim, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Altman, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513484
- Sponsor's protocol ID
- NU 17H04
- Other IDs
- NCI-2018-00483, STU00206525, NU 17H04, P30CA060553
- Status last verified
- Oct 2025
- First submitted
- 19 Apr 2018
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Open Label, Combination Study of Nintedanib With 5-Azacitidine in Acute Myeloid Leukemia Characterized by HOX Gene Overexpression, That Are Not Candidates of Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT03513484
- Acronym / sponsor ID
- NU 17H04
- Conditions
- Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication, Recurrent Adult Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center, Boehringer Ingelheim, National Cancer Institute (NCI)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 May 2018 (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 find the appropriate dose of the study drug nintedanib when combined with azacitidine and the associated side effects of the combination in older adults with AML characterized by HOX gene overexpression who are not interested in or not considered fit for standard intensive chemotherapy. The use of the study drug nintedanib in this study is investigational. Investigational means that this medication has not yet been approved by the FDA to treat this type of cancer. Azacitidine received FDA Approval in 2004 for myelodysplastic syndrome (a blood cancer related to AML) and has a National Comprehensive Cancer Network (NCCN) guideline recommendation for treatment of older adults who are not candidates for or decline intensive remission induction therapy. We expect participation to continue in this study based on each participant's response to the drug, and ability to tolerate treatment. Participants may continue to receive study treatments for 6 cycles (one cycle is 28 days long). If the 6 cycles of treatment is completed, participants may be moved on to a maintenance phase of treatment. Treatment will continue until the participant's leukemia gets worse, or they experience serious side effects, have a break in treatment for more than 56 days or the study doctor feels it is best for study treatments to stop.
Detailed description
PRIMARY OBJECTIVES:
- To identify maximum tolerated dose (MTD) of nintedanib for combination treatment of nintedanib and azacytidine (5-azacitidine) in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia with HOX overexpression and who are ineligible for intensive chemotherapy.
SECONDARY OBJECTIVES:
- Adverse events (AEs) including dose limiting toxicities (DLTs) will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
II. To determine median overall survival. III. To determine complete remission (CR) rate.
EXPLORATORY OBJECTIVES:
- To determine composite CR rate (CR + complete remission with incomplete platelet recovery [CRp] + complete remission with incomplete hematological recovery [Cri]).
II. To determine duration of confirmed response. III. To determine event free survival. IV. To determine leukemia free survival. V. To establish correlation between response and pre-treatment Fgf2 levels and change in Fgf-2 levels during treatment.
OUTLINE: This is a dose-escalation study of azacitidine.
Participants receive nintedanib orally (PO) twice daily (BID) on days 1-28 and azacitidine intravenously (IV) or subcutaneously (SC) on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks.
After completion of study treatment, participants are followed up at every 3 months for 12 months and then every 6 months for up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nintedanib, azacitidine) | Experimental | Drug: Azacitidine, Other: Laboratory Biomarker Analysis, Drug: NintedanibParticipants receive nintedanib PO BID on days 1-28 and azacitidine IV or SC on days 1-7. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, participants may discontinue treatment, receive nintedanib every 4-8 weeks, or receive nintedanib and azacitidine every 4-8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- ESCLATION COHORT: Patients must have a diagnosis of newly diagnosed and/ or relapsed/refractory AML with any of the following:
- EXPANSION COHORT: Patients must have a diagnosis of newly diagnosed AML with any of the following:
- Patients who are not candidates for, or decline, intensive therapy
- Patients must exhibit an ECOG performance status 0-3
- International normalized ratio (INR) ? 2 (If coagulopathy is related to disease, this criterion does not apply) within14 days prior to registration
Key exclusion criteria (36 listed)
- Patients who have received chemo-, hormone-, radio or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 14 days prior to start of treatment or those who have not recovered from adverse events attributed to the agent to grade 1 or baseline
- Patients who have received any other investigational product within14 days of treatment are not eligible for this study; a wash out period ? 14 days or 5 half- lives (whichever is greater) is required from investigational treatment, prior to start of study treatment; please Note:
- Patients who have had major injuries and/or surgery within the past 4 weeks (< 28 days) prior to registration with incomplete wound healing and/or planned surgery while the patient is on study treatment
- Patients who have proteinuria CTCAE version (v)4.03 grade 2 or greater within < 30 days of registration
- Patients who have significant cardiovascular diseases are not eligible; these are:
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 |
|---|---|---|
| AzacitidineAlso: 5 AZC, 5-AC, 5-Azacytidine, 5-AZCGiven IV or SC | Drug | Treatment (nintedanib, azacitidine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (nintedanib, azacitidine) |
| NintedanibAlso: BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120Given PO | Drug | Treatment (nintedanib, azacitidine) |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 28 days
Will be defined as the highest dose that causes dose limiting toxicities (DLTs) in < 2 of 6 patients.
3 secondary outcomes
Incidence of adverse events
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Complete remission (CR) rate
Time frame: Up to 24 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 21 Oct 2025.
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.
Jessica Altman principal investigator
Northwestern University
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 Azacitidine, Laboratory Biomarker Analysis and Nintedanib in people with Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A and Fibroblast Growth Factor Basic Form Measurement, run by Northwestern University 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 30 inclusion and 36 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 21 Oct 2025. 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?
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?
Maximum tolerated dose (MTD) (time frame: Up to 28 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 21 Oct 2025.