Acute Lymphoblastic Leukemia, PediatricPhase 2VHR ALLNCT06257394
Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
A Phase 2 study testing Dasatinib(Sprycel) arm and Non-Dasatinib(Sprycel) arm in people with Acute Lymphoblastic Leukemia, Pediatric, run by Hyoung Jin Kang at 10 sites in South Korea.
Trial summary
Very high-risk acute lymphoblastic leukemia Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Dasatinib(Sprycel) arm and Non-Dasatinib(Sprycel) arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 20 Oct 2024to 31 Dec 2034
- 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 1 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
- Philadelphia chromosome-positive t(9;22)(q34;q11) or
- Patients with failed remission who had blast > 5% on bone marrow test after initial remission induction therapy or
- Hypodiploidy (Number of chromosomes \< 44 (less than 44)) or
- E2A-HLF(Hepatic Leukemia Factor) translocation-positive or
- When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy
Who cannot join
- Participants with contraindications to medications
- When the study participant or their legal representative withdraws consent
- Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
- Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Kyungpook National University Chilgok-Hospital
Daegu, 41404
Ji Yoon Kim, Professor, +82-53-200-5704, phojyk@knu.ac.kr
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
Yeon Jung Lim, Professor, +82-10-2705-1743, heagori@daum.net
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Hee Jo Baek, Professor, +82-61-379-8060, swan93@naver.com
- Recruiting
Jeju National University Hospital
Jeju City, 63241
Hyun Sik Kang, Professor, +82-64-717-1528, medyapsb@naver.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyoung Jin Kang, Professor, +82-2-2072-3452, kanghj@snu.ac.kr
- Recruiting
Severance Hospital
Seoul, 03722
Seung-min Hahn, Professor, +82-2-2258-9943, bluenile88@yuhs.ac
- Recruiting
Asan Medical Center
Seoul, 05505
Ho Joon Im, Professor, 8201062311573, hojim@amc.seoul.kr
- Recruiting
Samsung Medical Center
Seoul, 06351
Hee Young Ju, Professor, +82-2-3410-0865, hyju320@gmail.com
- Recruiting
Seoul saint Mary's Hospital
Seoul, 06591
Jae Won Yoo, Professor, +82-2-2258-6763, hoiring0209@gmail.com
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Eu Jeen Yang, Professor, +82-10-6478-8489, 41sirius@hanmail.net
About this study
Official title: Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Very high-risk acute lymphoblastic leukemia
Read the detailed description
- Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
- Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance
- If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease \& qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
- If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
- In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
- Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
- Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine
- If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Dasatinib(Sprycel) arm, Non-Dasatinib(Sprycel) arm
- Keywords
- VHR ALL, NGS-MRD
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib(Sprycel) armDrug
▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
- Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance
- If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT
- If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
- If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab
- In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
Non-Dasatinib(Sprycel) armDrug
▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
- Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT
- If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT
- If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
- If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab
| Study group | Role | What they receive |
|---|---|---|
| [Arm A, Dasatinib(Sprycel) Arm] | Experimental | ▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance
2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT
1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab
* In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib. Receives: Drug: Dasatinib(Sprycel) arm |
| [Arm B, Non-Dasatinib(Sprycel) Arm] | Experimental | ▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
* Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT
2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
* M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT
1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab Receives: Drug: Non-Dasatinib(Sprycel) arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: Up to 5 years
Secondary outcomes (5)
Overall survival
The time until defined by date of all-cause mortality from the date of 1st infusion
Measured: Up to 5 years
Recurred rate
As the period from enrollment to disease progression/recurrence
Measured: Up to 5 years
Death rate related to infusion
The time until defined by date of drug-related mortality from the date of 1st infusion
Measured: Up to 5 years
Adverse Event
Measured: From Day 1 of the clinical trial to 28 days after last drug administration
The rate of Hematopoietic stem cell transplantation
The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy
Measured: 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.
- First posted14 Feb 2024
- Study start20 Oct 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyoung Jin Kang
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Severance Hospital, Pusan National University Yangsan Hospital, Seoul St. Mary's Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, Jeju National University Hospital
- Responsible party
- Sponsor-investigator, Hyoung Jin Kang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257394
- Sponsor's protocol ID
- H-2401-028-1500
- Acronym
- VHR ALL
- Status last verified
- Jul 2026
- First submitted
- 1 Feb 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
- ClinicalTrials.gov ID
- NCT06257394
- Acronym / sponsor ID
- VHR ALL / H-2401-028-1500
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- VHR ALL, NGS-MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hyoung Jin KangUniversity, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Severance Hospital, Pusan National University Yangsan Hospital, Seoul St. Mary's Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, Jeju National University Hospital
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very high-risk acute lymphoblastic leukemia
Detailed description
- Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
- Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance
- If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease \& qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
- If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
- In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
- Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
- Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
- If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine
- If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [Arm A, Dasatinib(Sprycel) Arm] | Experimental | Drug: Dasatinib(Sprycel) arm▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib. |
| [Arm B, Non-Dasatinib(Sprycel) Arm] | Experimental | Drug: Non-Dasatinib(Sprycel) arm▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
Key exclusion criteria (4 listed)
- Participants with contraindications to medications
- When the study participant or their legal representative withdraws consent
- Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
- Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol
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 |
|---|---|---|
| Dasatinib(Sprycel) arm▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib. | Drug | [Arm A, Dasatinib(Sprycel) Arm] |
| Non-Dasatinib(Sprycel) arm▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab | Drug | [Arm B, Non-Dasatinib(Sprycel) Arm] |
Primary outcome
Event free survival
Time frame: Up to 5 years
5 secondary outcomes
Overall survival
Time frame: Up to 5 years
Recurred rate
Time frame: Up to 5 years
Death rate related to infusion
Time frame: Up to 5 years
Adverse Event
Time frame: From Day 1 of the clinical trial to 28 days after last drug administration
The rate of Hematopoietic stem cell transplantation
Time frame: Up to 5 years
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib(Sprycel) arm and Non-Dasatinib(Sprycel) arm in people with Acute Lymphoblastic Leukemia, Pediatric, run by Hyoung Jin Kang at 10 sites in South Korea.
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 6 inclusion and 4 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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?
Contact Hyoung Jin Kang, Ph.D (+82-2-2072-3452, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: Up to 5 years). 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 29 Jul 2026.