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NeuroblastomaPhase 2NCT05303727

Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma

A Phase 2 study testing Anti Thymocyte Globulin, Fludarabine and Cyclophosphamide injection in people with Neuroblastoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Neuroblastoma (NB) is the most common extracranial solid tumor of embryonal origin in children. According to the International Neuroblastoma Risk Group (INRG) staging criteria and the International Neuroblastoma Staging System (INSS) ，NB preoperative staging is divided into L1, L2, M and Ms stages, the postoperative… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Neuroblastoma
What is being tested?
Anti Thymocyte Globulin, Fludarabine and Cyclophosphamide injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
Aug 2022to Aug 2027
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult
  1. Evaluation criteria for disease before and after transplantation:
  2. Complete response (CR): all primary and metastatic lesions disappear, and neuron specific enolase (NSE), catecholamines and metabolites return to normal.
  3. Very good partial response (VGPR): the primary tumor volume is reduced by 90% to 99%, all measurable metastases disappear, and NSE, catecholamines and metabolites return to normal; radionuclide bone scanned lesions can be positive (because bone metastases have not healed), but if an metaiodobenzylguanidine (MIBG) scan is performed, all lesions are negative.
  4. Partial response (PR): The volume of all primary tumors and measurable metastases is reduced by more than 50%, the number of bone-positive lesions is reduced by more than 50%, and there is no more than one bone-positive site.
  5. Mixed response (MR): no new lesions, the volume of any one or more measurable lesions decreases more than 50%, and the volume of any other one or more lesions decreases less than 50%, and volume of any existing lesions increases less than 25%.
  6. No response (NR): There are no new lesions, and the volume of any existing lesions decreases less than 50% or increases less than 25%.
  7. Progressive disease (PD): new lesions appear, the volume of existing measurable lesions increases more than 25%, and the bone marrow changes from negative to positive.
  8. Inclusion Criteria: one of the following criteria (2), (3) or (4) must be met and all other criterions must be met at the same time:
  9. Age≤18 years old;
  10. After at least 7 courses of induction chemotherapy (surgical resection of the primary tumor or metastatic disease has been completed during the period), evaluation of disease is CR, tumor markers (blood NSE and urine VMA) and minimal residual disease by flow cytometry of bone marrow and peripheral blood are negative; the primary tumor has completed radiotherapy before HSCT;
  11. For patients with PR or VGPR, tumor markers (blood NSE and urine VMA) and minimal residual disease by flow cytometry of bone marrow and peripheral blood are negative; the primary tumor and metastatic lesions have completed radiotherapy before HSCT;
  12. Relapsed patients achieve CR/VGPR/PR after re-induction or salvage chemotherapy, tumor markers (blood NSE and urine VMA) and minimal residual disease by flow cytometry of bone marrow and peripheral blood are negative; the primary tumor and metastatic lesions have completed radiotherapy before HSCT;
  13. Whole brain and whole spinal cord radiotherapy have completed before HSCT in patients with central invasion at onset;
  14. The blood routine has generally returned to normal and there is no dysfunction of major organs such as the heart, liver, lung, and kidney;
  15. The guardian/patient accept the treatment of this research, sign the informed consent, and complete the follow-up.
  16. Exclusion Criteria: meeting one of the following criterions:
  17. With severe cardiac insufficiency, cardiac ejection fraction (EF) is less than 50%; or severe cardiac disease, the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  18. With severe pulmonary insufficiency (severe obstructive and/or restrictive ventilation disorders), the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  19. With severe liver function impairment, ALT>5 times upper limit of normal, or total bilirubin>3 times upper limit of normal; the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  20. With severe renal insufficiency, creatinine>2 times upper limit of normal; or corrected creatinine clearance rate Ccr<50ml/min; the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  21. With severe active bleeding or severe active infection; the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  22. Allergic reactions or serious adverse reactions occurred in the previous use of conditioning regimen-related drugs, the patient can not tolerate the conditioning regimen according to the investigators' evaluation;
  23. The guardian/patient cannot understand or comply with the treatment plan;
  24. Other reasons for not being selected due to the investigator's evaluation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ke Huang, MD contact

+8602034070821

hke@mail.sysu.edu.cn

Su Liu, MD contact

+8613512742517

liusu2009@163.com

China1 site

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Ke Huang, MD, +8602034070821, hke@mail.sysu.edu.cn

    Su Liu, MD, +8613512742517, liusu2009@163.com

Other trials in China

About this study

Official title: Clinical Research of Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Children With Stage 4/M Neuroblastoma: A Prospective, Single-arm, Phase II, Multi-center Trial

Neuroblastoma (NB) is the most common extracranial solid tumor of embryonal origin in children. According to the International Neuroblastoma Risk Group (INRG) staging criteria and the International Neuroblastoma Staging System (INSS) ，NB preoperative staging is divided into L1, L2, M and Ms stages, the postoperative staging is divided into 1 to 4 stages and 4s stage. Among them, 4/M stage is of the highest degree of malignancy and the worst prognosis. Despite the aggressive combination therapy, the 5-year survival rate (OS) is still less than 15%, and the 2-year relapse rate is 80%. Currently, no effective treatment is accessible for refractory/relapsed stage 4/M NB after completing conventional therapy.

In hematopoietic stem cell transplantation (HSCT) , conditioning regimen with high-dose radiotherapy and chemotherapy is implemented to eradicate tumor cells and abnormal clonal cells in the patient, block the pathogenesis, and restore the patient's hematopoietic and immune systems by transplanting normal hematopoietic stem cells. According to the source of hematopoietic stem cells, HSCT can be divided into two types: autologous hematopoietic stem cell transplantation (auto-HSCT) and allogeneic hematopoietic stem cell transplantation (allo-HSCT). It has been confirmed that benefiting from the graft versus tumor(GVT) effect, allo-HSCT can clear residual lesions in refractory/relapsed NB patients post-auto-HSCT，and prolong the survival time of patients. Our center has explored the conditioning regimen, treatment of residual tumor lesions before transplantation, and strategies to reduce transplantation-related death (TRM) and enhance the GVT effect. However, the sample size is small, and multicenter and larger sample size research are needed. This study will further observe the clinical efficacy and safety of allo-HSCT in the treatment of 4/M stage NB, and provide a new treatment method and option for 4/M stage NB.

Read the detailed description

Purposes: To evaluate the efficacy and safety of allo-HSCT in children with stage 4/M high-risk NB through a multi-center prospective single-arm clinical research grouped according to different types of donors, graft sources, and stratified conditioning regimen.

Primary objectives: To evaluate the efficacy (3-year OS, EFS) of allo-HSCT in the treatment of children with stage 4/M NB through a multicenter prospective single-arm clinical study.

Secondary objectives:

  1. To evaluate the safety of allo-HSCT in the treatment of children with stage 4/M NB [toxicity of conditioning regimen, engraftment rate, early transplantation-related mortality (<100d TRM), transplantation-related complications (VOD, thrombotic microangiopathy(TMA), acute/chronic graft-versus-host disease (GVHD), Epstein-Barr virus(EBV)/cytomegalovirus(CMV) viremia and EBV/CMV related diseases or other pathogenic infections, etc.];
  2. Improvement and optimization of allo-HSCT conditioning regimen. Outline: This is a multicenter study. Conditioning regimen: There are 3 protocols according to different sources of donor: (1) Cord blood HSCT: Flu+Bu+cyclophosphamide (CTX)+Topotecan (without ATG); (2) Peripheral blood HSCT or haploid bone marrow combined with peripheral stem cell transplantation: Flu+Bu+Melphalan+Antithymocyte globulin (ATG)+ Thiotepa (TT) or (3) Flu+Bu+Melphalan+ATG (applicable to peripheral stem cells or haploid bone marrow combined with peripheral stem cell transplantation for which TT cannot be used).

Transplantation: Patients undergo cord blood stem cell or bone marrow or granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cell transplantation on day 0.

GVHD prophylaxis: Cyclosporine or tacrolimus combined with methotrexate is used for related matched transplantation, cyclosporine combined with mycophenolate mofetil for umbilical cord blood transplantation, and cyclosporine combined with mycophenolate mofetil and methotrexate for haploidentical transplantation to prevent GVHD.

After completion of transplantation, patients are followed periodically at least 3 years.

Conditions
Neuroblastoma
Being tested
Anti Thymocyte Globulin, Fludarabine, Cyclophosphamide injection, Topotecan, Melphalan
Keywords
allogeneic stem cell transplantation
Medical subject headings
Neuroblastoma

What participants receive

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

  • Anti Thymocyte GlobulinDrug

    Also called ATG

    2.5 mg/kg/day；2 doses on day -3 and day -2 for matched sibling donor transplantation；3 doses on day -4，-3 and day -2 for unrelated donor transplantation；4 doses on day -5，-4，-3 and day -2 for haploidentical donor transplantation

  • FludarabineDrug

    Also called Fludara

    30 mg/m2/day for 5 days

  • Cyclophosphamide injectionDrug

    Also called CTX

    60 mg/kg/day for 2 days in cord blood stem cell transplantation

  • TopotecanDrug

    Also called Topotecan Hydrochloride

    2mg/m2/day for 3 days in cord blood stem cell transplantation

  • MelphalanDrug

    Also called Alkeran

    70mg/m2/day，for peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation；2 doses on day -3 and day -2 when conditioning regimen containing thiotepa；3 doses on day -4，-3 and day -2 when conditioning regimen not containing thiotepa；

  • ThiotepaDrug

    Also called thiophosphoramide

    5 mg/kg/day for 2 days in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation

  • BusulfanDrug

    Also called Busulfex

    0.8mg/kg/dose；8 doses in cord blood stem cell transplantation；12 doses in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation when conditioning regimen containing thiotepa；16 doses in peripheral stem cell transplantation or haploidentical bone marrow combined with peripheral stem cell transplantation when conditioning regimen not containing thiotepa；

  • CyclosporineDrug

    Also called Sandimmune

    2.5~4 mg/kg/dose every 12 hours orally；1.5~2 mg /kg/dose every 12 hours intravenously; trough concentration maintained at 150~250ng/ml

  • TacrolimusDrug

    Also called Prograf

    0.02~0.03 mg/kg/day as continuous infusion or 12 hour divided doses

  • Mycophenolate MofetilDrug

    Also called Cellcept

    15 mg/kg/dose every 12 hours

  • MethotrexateDrug

    Also called amethopterin

    15 mg/m2/dose on d+1 and 10 mg/m2/dose on d+3，d+6 in peripheral stem cell transplantation

Study groups in NCT05303727
Study groupRoleWhat they receive
Conditioning regimen for different sources of donorsExperimentalThere are 3 groups according to different sources of donor: (1) Cord blood HSCT: Flu+Bu+CTX+Topotecan (without ATG); (2) Peripheral blood HSCT or haploid bone marrow combined with peripheral stem cell transplantation: Flu+Bu+Melphalan+Antithymocyte globulin (ATG)+ Thiotepa (TT) or (3) Flu+Bu+Melphalan+ATG (applicable to peripheral stem cells or haploid bone marrow combined with peripheral stem cell transplantation for which TT cannot be used).
Receives: Drug: Anti Thymocyte Globulin; Drug: Fludarabine; Drug: Cyclophosphamide injection; Drug: Topotecan; Drug: Melphalan; Drug: Thiotepa; Drug: Busulfan; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Methotrexate

What is being measured

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

  1. overall survival(OS) at 3 year

    From the date of day 0 of transplantation until the date of death from any cause

    Measured: 3 years post-HSCT

  2. event free survival(EFS) at 3 year

    Survival time from day 0 of transplantation to the occurrence of the first adverse event. Disease or treatment-related adverse events, such as tumor recurrence, implant failure, and death, are counted in this study; accidental deaths that assessed unrelated to the above factors are not included

    Measured: 3 years post-HSCT

Secondary outcomes (8)

  1. incidence of conditioning toxicity

    Conditioning toxicity is graded according to the Common Terminology Criteria for Adverse Events(CTCAE Version 5.0)

    Measured: 100 days post-HSCT

  2. incidence of donor engraftment

    Donor engraftment represents donor cells replace at least 95% of recipient hematopoietic stem cells.

    Measured: 100 days post-HSCT

  3. early transplant-related mortality

    Death due to transplantation, excluding other causes such as disease progression or relapse.

    Measured: 100 days post-HSCT

  4. incidence of sinusoidal obstruction syndrome

    Sinusoidal obstruction syndrome is diagnosed according to classification from the European society for blood and marrow transplantation.

    Measured: 3 years post-HSCT

  5. incidence of transplant associated thrombotic microangiopathy(TA-TMA)

    TA-TMA is diagnosed according to the Jodele standard.

    Measured: 3 years post-HSCT

  6. incidence of acute graft versus host disease

    Acute graft versus host disease is diagnosed according to the modified Glucksberg grading standard.

    Measured: 100 days post-HSCT

  7. incidence of infection

    e.g. EBV/CMV viremia or related disease, bacteria/fungi /tuberculosis infection

    Measured: 3 years post-HSCT

  8. incidence of chronic graft versus host disease

    Chronic graft versus host disease is diagnosed according to the grading and scoring system recommended by the "Chinese Consensus on the Diagnosis and management of Chronic Graft-versus-Host Disease(2021)".

    Measured: 3 years post-HSCT

Timeline

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

  1. First posted31 Mar 2022
  2. Study startAug 2022 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
There are 3 groups according to different sources of donor: (1) Cord blood HSCT: Flu+Bu+CTX+Topotecan (without ATG); (2) Peripheral blood HSCT or haploid bone marrow combined with peripheral stem cell transplantation: Flu+Bu+Melphalan+Antithymocyte globulin (ATG)+ Thiotepa (TT) or (3) Flu+Bu+Melphalan+ATG (applicable to peripheral stem cells or haploid bone marrow combined with peripheral stem cell transplantation for which TT cannot be used).
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303727
Sponsor's protocol ID
2021-KY-126
Status last verified
Mar 2022
First submitted
16 Mar 2022
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pastor ER, Mousa SA. Current management of neuroblastoma and future direction. Crit Rev Oncol Hematol. 2019 Jun;138:38-43. doi: 10.1016/j.critrevonc.2019.03.013. Epub 2019 Apr 1.

    PubMed 31092383

  • Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, Elliott M, Moreno L, Barone G, Pearson AD, James PW, Tweddle DA, McNally RJ. Factors associated with recurrence and survival length following relapse in patients with neuroblastoma. Br J Cancer. 2016 Oct 25;115(9):1048-1057. doi: 10.1038/bjc.2016.302. Epub 2016 Oct 4.

    PubMed 27701387

  • Monclair T, Brodeur GM, Ambros PF, Brisse HJ, Cecchetto G, Holmes K, Kaneko M, London WB, Matthay KK, Nuchtern JG, von Schweinitz D, Simon T, Cohn SL, Pearson AD; INRG Task Force. The International Neuroblastoma Risk Group (INRG) staging system: an INRG Task Force report. J Clin Oncol. 2009 Jan 10;27(2):298-303. doi: 10.1200/JCO.2008.16.6876. Epub 2008 Dec 1.

    PubMed 19047290

  • Brodeur GM, Pritchard J, Berthold F, Carlsen NL, Castel V, Castelberry RP, De Bernardi B, Evans AE, Favrot M, Hedborg F, et al. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J Clin Oncol. 1993 Aug;11(8):1466-77. doi: 10.1200/JCO.1993.11.8.1466.

    PubMed 8336186

  • Smith V, Foster J. High-Risk Neuroblastoma Treatment Review. Children (Basel). 2018 Aug 28;5(9):114. doi: 10.3390/children5090114.

    PubMed 30154341

  • London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, Naranjo A, Park JR. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials. Cancer. 2017 Dec 15;123(24):4914-4923. doi: 10.1002/cncr.30934. Epub 2017 Sep 8.

    PubMed 28885700

  • Matthay KK, Reynolds CP, Seeger RC, Shimada H, Adkins ES, Haas-Kogan D, Gerbing RB, London WB, Villablanca JG. Long-term results for children with high-risk neuroblastoma treated on a randomized trial of myeloablative therapy followed by 13-cis-retinoic acid: a children's oncology group study. J Clin Oncol. 2009 Mar 1;27(7):1007-13. doi: 10.1200/JCO.2007.13.8925. Epub 2009 Jan 26.

    PubMed 19171716

  • Ladenstein R, Potschger U, Pearson ADJ, Brock P, Luksch R, Castel V, Yaniv I, Papadakis V, Laureys G, Malis J, Balwierz W, Ruud E, Kogner P, Schroeder H, de Lacerda AF, Beck-Popovic M, Bician P, Garami M, Trahair T, Canete A, Ambros PF, Holmes K, Gaze M, Schreier G, Garaventa A, Vassal G, Michon J, Valteau-Couanet D; SIOP Europe Neuroblastoma Group (SIOPEN). Busulfan and melphalan versus carboplatin, etoposide, and melphalan as high-dose chemotherapy for high-risk neuroblastoma (HR-NBL1/SIOPEN): an international, randomised, multi-arm, open-label, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):500-514. doi: 10.1016/S1470-2045(17)30070-0. Epub 2017 Mar 2.

    PubMed 28259608

  • Du H, Chen J, Qin M, Fang J, Li Z, Zhu Y, Sun X, Huang D, Yu J, Tang Y, Hu S, Li J, Zhang Z, Luan Z. Pediatric hematopoietic stem cell transplantation in China: Data and trends during 1998-2012. Pediatr Transplant. 2015 Aug;19(5):563-70. doi: 10.1111/petr.12525. Epub 2015 Jun 8.

    PubMed 26058853

  • Uemura S, Ishida T, Thwin KKM, Yamamoto N, Tamura A, Kishimoto K, Hasegawa D, Kosaka Y, Nino N, Lin KS, Takafuji S, Mori T, Iijima K, Nishimura N. Dynamics of Minimal Residual Disease in Neuroblastoma Patients. Front Oncol. 2019 Jun 4;9:455. doi: 10.3389/fonc.2019.00455. eCollection 2019.

    PubMed 31214500

  • Hirayama M, Azuma E, Araki M, Komada Y, Nakagawa A. Evidence of graft-versus-tumor effect in refractory metastatic neuroblastoma. Transplantation. 2006 Jul 15;82(1):142-4. doi: 10.1097/01.tp.0000225780.90991.49. No abstract available.

    PubMed 16861958

  • Marabelle A, Paillard C, Tchirkov A, Halle P, Chassagne J, Demeocq F, Kanold J. Graft-versus-tumour effect in refractory metastatic neuroblastoma. Bone Marrow Transplant. 2007 Jun;39(12):809-10. doi: 10.1038/sj.bmt.1705681. Epub 2007 Apr 23. No abstract available.

    PubMed 17450181

  • Matthay KK, Seeger RC, Reynolds CP, Stram DO, O'Leary MC, Harris RE, Selch M, Atkinson JB, Haase GM, Ramsay NK. Allogeneic versus autologous purged bone marrow transplantation for neuroblastoma: a report from the Childrens Cancer Group. J Clin Oncol. 1994 Nov;12(11):2382-9. doi: 10.1200/JCO.1994.12.11.2382.

    PubMed 7964954

  • Ladenstein R, Lasset C, Hartmann O, Klingebiel T, Bouffet E, Gadner H, Paolucci P, Burdach S, Chauvin F, Pinkerton R, et al. Comparison of auto versus allografting as consolidation of primary treatments in advanced neuroblastoma over one year of age at diagnosis: report from the European Group for Bone Marrow Transplantation. Bone Marrow Transplant. 1994 Jul;14(1):37-46.

    PubMed 7951119

  • Yi ES, Son MH, Hyun JK, Cho HW, Ju HY, Lee JW, Yoo KH, Sung KW, Koo HH. Predictors of survival in patients with high-risk neuroblastoma who failed tandem high-dose chemotherapy and autologous stem cell transplantation. Pediatr Blood Cancer. 2020 Feb;67(2):e28066. doi: 10.1002/pbc.28066. Epub 2019 Nov 17.

    PubMed 31736249

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti Thymocyte Globulin, Fludarabine and Cyclophosphamide injection in people with Neuroblastoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 1 Jul 2022. 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 China. 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 Ke Huang, MD (+8602034070821, hke@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival(OS) at 3 year (time frame: 3 years post-HSCT). 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 NCT05303727, which also lists 29 linked publications.

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 1 Jul 2022.

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