Acute Lymphoblastic LeukemiaLAL-2025NCT07443592
Treatment for Ph-negative ALL for Adults up to 65 Years
A study testing Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) and Transplantation in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 95 sites in Spain.
Trial summary
The goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) and Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 95 sitesSpain
- Study dates
- 6 Mar 2026to 1 Jun 2033
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo ALL.
- Age 18-65 years.
- No prior treatment, except:
- Urgent leukapheresis, Urgent treatment of hyperleukocytosis with hydroxyurea, Urgent cranial irradiation (one dose) for CNS leukostasis, Urgent mediastinal irradiation for superior vena cava syndrome.
- Adequate general condition (ECOG score 0-2), or >2 if due to ALL.
- Negative pregnancy test for women of childbearing age.
Who cannot join
- Age > 65 years.
- ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).
- Ph-positive B-cell ALL (BCR::ABL1).
- Lymphoid blast crisis of chronic myeloid leukemia.
- Patients with a history of coronary artery disease, valvular heart disease, or hypertensive heart disease, which contraindicates the use of anthracyclines.
- Patients with active chronic liver disease.
Show all 13Show fewer
- Patients with severe chronic respiratory failure.
- Renal insufficiency not due to ALL.
- Severe neurological disorders, not due to ALL, that contraindicate the use of these treatments (especially blinatumomab).
- History of clinically significant pancreatitis, at the investigator's discretion (taking into account the date of the pancreatitis, its previous severity, and sequelae).
- Pregnancy or breastfeeding.
- Psychiatric or mental illness that prevents providing informed consent for sample submission or adequately participating in the study.
- Impaired general health (ECOG scores 3 and 4) not attributable to ALL.
Trial locations and contacts
95 sites in 1 country. Contact the study team or a site near you to ask about taking part.
95 sites in 1 country
Spain95 sites
Hospital de A Coruña
A Coruña
Victor Noriega, Dr
Hospital Universitario de Araba
Alava
Pilar Romero, Dr
Hospital General Universitario de Albacete
Albacete
Jesús Lorenzo Algarra, Dr
Hospital General Universitario Dr. Balmis
Alicante
Carmen Botella, Dr
Hospital Universitario Torrecárdenas
Almería
María José García, Dr
Hospital General de Lanzarote
Arrecife
Azueg Hong, Dr
Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila
Ávila
María Paz Martínez, Dr
Hospital Universitario de Badajoz
Badajoz
María Soledad Casado, Dr
ICO-Hospital Germans Trias i Pujol
Badalona
Anna Torrent, Dr
Hospital Clínic de Barcelona
Barcelona
Núria Martínez, Dr
Hospital de Sant Pau
Barcelona
Irene García, Dr
Hospital del Mar
Barcelona
Lucía Gómez, Dr
Hospital QuirónSalud
Barcelona
Yva Rodríguez, Dr
Hospital Vall d'Hebrón
Barcelona
Pere Barba, Dr
Basurtuko Ospitalea
Bilbao
Cristina Barrenetxea, Dr
Hospital Universitario de Burgos
Burgos
Jorge Labrador, Dr
Hospital San Pedro Alcántara
Cáceres
Juan Bergua, Dr
Hospital Puerta del Mar
Cadiz
José Ángel Raposo, Dr
Hospital Universitario Santa Lucía
Cartagena
Antonio Martínez, Dr
Hospital General de Castellón
Castelló
Raimundo García, Dr
Hospital General de Ciudad Real
Ciudad Real
Raúl Vanegas, Dr
Hospital Universitario Reina Sofía
Córdoba
Josefina Serrano, Dr
Hospital Universitario de Cruces
Cruces
Javier Arzuaga, Dr
Hospital Virgen de la Luz
Cuenca
María José Busto, Dr
Hospital Universitario de Donostia
Donostia / San Sebastian
Teresa Artola, Dr
Hospital de Fuenlabrada
Fuenlabrada
Pilar Bravo, Dr
Hospital Universitario de Galdakao
Galdakao
Matxalen Olivares, Dr
Hospital de Getafe
Getafe
Cristian Escolano, Dr
ICO-Hospital Josep Trueta
Girona
Marta Sitges, Dr
Area Hospitalaria Juan Ramón Jimenez
Huelva
María Solé, Dr
Consorcio Hospitalario de Jaén
Jaén
Juan Antonio López, Dr
Hospital Jerez de la Frontera
Jerez de la Frontera
Lourdes Hermosín, Dr
ICO-Hospital Duran i Reynals
L'Hospitalet de Llobregat
Clara Maluquer, Dr
C. H. U. de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria
Carlos Rodríguez, Dr
Complejo Hospitalario Universitario Insular Materno Infantil de Canarias
Las Palmas de Gran Canaria
Rosa Fernández, Dr
Hospital Severo Ochoa
Leganés
Lorena Abalo, Dr
Hospital Universitario de León
León
Nora Suárez, Dr
Hospital Arnau de Vilanova
Lleida
Antoni Garcia, Dr
Hospital San Pedro
Logroño
Andrea Campeny, Dr
Hospital Universitario Lucus Augusti
Lugo
Aitor Abuín, Dr
C. H. Gregorio Marañón
Madrid
Ignacio Alberto Gómez, Dr
Clínica Universidad Navarra
Madrid
Carlos Grande, Dr
Hospital Clínico San Carlos
Madrid
Marta Mateo, Dr
Hospital Doce de Octubre
Madrid
Pilar Martínez, Dr
Hospital Infanta Leonor
Madrid
María Ángeles Foncillas, Dr
Hospital La Princesa
Madrid
Javier Ortín, dr
Hospital La Zarzuela
Madrid
Daniel García, Dr
Hospital Príncipe de Asturias
Madrid
Paula Gili, Dr
Hospital Ramón y Cajal
Madrid
Pilar Herrera, Dr
Hospital Ruber Juan Bravo
Madrid
Aranzazu Alonso, Dr
Hospital Sanchinarro
Madrid
Laura Llorente, Dr
Hospital Universitario Fundación Jiménez Díaz
Madrid
Laura Solán, Dr
Hospital Universitario HLA Moncloa
Madrid
Concha Alaez, Dr
Hospital Universitario Infanta Sofía
Madrid
Alícia Roldán, Dr
Hospital Universitario La Paz
Madrid
Irene Sánchez, Dr
Hospital Universitario Quirónsalud
Madrid
Virginia Pradillo, Dr
MD Anderson Cancer Center
Madrid
Alejandro Bobes, Dr
Hospital Puerta de Hierro
Majadahonda
Ana Bocanegra, Dr
. Hospital Clínico Universitario Virgen de la Victoria
Málaga
María Paz Queipo, Dr
Hospital QuirónSalud
Málaga
Rahinatu Awol, Dr
Hospital Regional Universitario de Málaga (Carlos Haya)
Málaga
Daniel Barrios, Dr
Hospital Morales Meseguer
Murcia
María Luz Amigo, Dr
Hospital Virgen de la Arrixaca
Murcia
Joaquín Gómez, Dr
Complejo Hospitalario Universitario de Ourense
Ourense
José Ángel Méndez, Dr
Hospital Central de Asturias
Oviedo
Teresa Bernal, Dr
Complejo Asistencial de Palencia
Palencia
Jackeline Solano, Dr
Hospital Son Espases
Palma de Mallorca
Andrés Novo, Dr
Hospital Universitari Son Llàtzer
Palma de Mallorca
Antonia Cladera, Dr
Clínica Universidad Navarra
Pamplona
José Rifón, Dr
Hospital Universitario de Navarra
Pamplona
Maria Carmen Mateos, Dr
Complejo Hospitalario Pontevedra (CHUP)-Montecelo
Pontevedra
María Lourdes Amador, Dr
C. Asistencial U. de Salamanca
Salamanca
Mónica Cabrero, Dr
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife
María Teresa Busnego, Dr
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Bernardo Javier González, Dr
Hospital Universitario Marqués de Valdecilla
Santander
Arancha Bermúdez, Dr
C H Santiago de Compostela
Santiago de Compostela
Natalia Alonso, Dr
Hospital General de Segovia
Segovia
Ana Torres, Dr
Consoorcio Hospitalario Virgen de Valme
Seville
Encarnación Gil, Dr
Hospital Virgen de la Macarena
Seville
Rafael Flores, Dr
Hospital Virgen del Rocío
Seville
José González, Dr
ICO-Hospital Joan XXIII
Tarragona
Ana Vicent, Dr
Hospital Universitari Mútua Terrassa
Terrassa
Ferran Vall-llovera, Dr
Hospital Universitario de Toledo
Toledo
Laura Parrilla, Dr
Hospital Universitario de Torrejón
Torrejón de Ardoz
Mirian Santero, Dr
Hospital Arnau de Vilanova
Valencia
Carmen Benet, Dr
Hospital Clínico de Valencia
Valencia
Mar Tormo, Dr
Hospital Doctor Peset
Valencia
Miriam Panero, Dr
Hospital General de Valencia
Valencia
Armando Mena-Duran, Dr
Hospital Universitari i Politècnic La Fe
Valencia
Pau Montesinos, Dr
Hospital Clínico Universitario de Valladolid
Valladolid
Lara Gómez, Dr
Hospital Río Hortega
Valladolid
Alberto Cantalapiedra, Dr
Hospital Álvaro Cunqueiro
Vigo
Sandra Suárez, Dr
Complejo Asistencial de Zamora
Zamora
Carmen Montes, Dr
Hospital Lozano Blesa
Zaragoza
Mayte Olave, Dr
Hospital Miguel Servet
Zaragoza
Beatriz de Rueda, Dr
About this study
Official title: Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years
The goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. The main question is to know if the incorporation of blinatumomab for B-cell precursor ALL, substituting some chemotherapy blocks, offers better probability of survival than the previous trial, which did not use immunotherapy. In addition, T-cell precursor ALL participants will receive different treatment approaches depending on the stage of maturation of the tumor.
Read the detailed description
Participants will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant participants will receive a second induction with inotuzumab for B-cell precursor ALL or with FLAG-Ida (fludarabine, cytarabine, idarubicin and granulocyte colony stimulating factor) for T-cell precursor ALL.
B-cell precursor ALL participants with adequate MRD clearance after cycle 1 of blinatumomab will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.
T-cell precursor ALL participants with adequate MRD clearance after the first cycle of consolidation will receive 2 blocks of early consolidation and reinduction. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification and maintenance. The remaining patients will receive early or delayed alloHSCT.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL), Transplantation
- Keywords
- ALL, adult, Philadephia-negative, minimal residual disease, genetics, immunotherapy, transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)Drug
Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine). Blinatumomab cycles in consolidation therapy for participants with B-cell precursor ALL.
TransplantationProcedure or surgery
allogeneic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy (+ blinatumomab for B-cell precursor ALL) | Other | Pediatric-inspired chemotherapy Receives: Drug: Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) |
| Transplantation | Other | allogeneic stem cell transplantation Receives: Procedure: Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival comparison versus previous trial
Comparison of time from diagnosis to death or last follow-up between the present LAL-2025 trial and the previous LAL19 trial for adult Ph-negative
Measured: 5 years
Secondary outcomes (5)
Complete remission (CR) rate
Proportion of participants who achieve CR with or 2 induction therapy lines
Measured: 4 or 8 weeks after treatment onset
MRD status after induction and consolidation
Proportion of participants who achieve and maintain the negative MRD status (<10-4)
Measured: After induction (4-8 weeks) and consolidation (16-20 weeks)
MRD variation between induction and after cycle 1 blinatumomab
Proportion of B-cell precursor ALL participants who achieve and maintain the negative MRD status (<10-4) at week 4 or 8 (end of induction 1 or 2) and after week 8 or 12 (after blinatumomab cycle1)
Measured: After induction (4-8 weeks) and after cycle 1 blinatumomab (8-12 weeks)
Frequency of allogeneic stem cell transplantation (alloSCT) dut to high-risk genetics
Proportion of participants that are allocated to alloSCT exclusively due to the presence to high-risk genetic alterations defined in the trial
Measured: 5 years
Effect of blinatumomab within each B-cell precursor ALL genetic subtype
Proportion of paarticipants with negative MRD status within each B-cell precursor ALL genetic subtype according to the World Health Organization (WHO) and the International Consensus Classification of Acute Leukemia (ICC)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start6 Mar 2026 (estimated)
- Primary completion6 Mar 2031 (estimated)
- Study completion1 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Torrent, Dr, Study chair, Germans Trias i Pujol HospitalPere Barba, Dr, Study chair, Hospital Vall d'HebrónJosep Maria Ribera, Prof, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443592
- Sponsor's protocol ID
- PETHEMA LAL-2025
- Acronym
- LAL-2025
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years
- ClinicalTrials.gov ID
- NCT07443592
- Acronym / sponsor ID
- LAL-2025 / PETHEMA LAL-2025
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, adult, Philadephia-negative, minimal residual disease, genetics, immunotherapy, transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 6 Mar 2026 (estimated)
- Primary completion
- 6 Mar 2031 (estimated)
- Study completion
- 1 Jun 2033 (estimated)
- First posted
- 2 Mar 2026 (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 goal of this trial is to provide a protocol for treatment for adults with Ph-negative acute lymphoblastic leukemia (ALL) and to learn if this provides higher probability of survival than the previous one. The main question is to know if the incorporation of blinatumomab for B-cell precursor ALL, substituting some chemotherapy blocks, offers better probability of survival than the previous trial, which did not use immunotherapy. In addition, T-cell precursor ALL participants will receive different treatment approaches depending on the stage of maturation of the tumor.
Detailed description
Participants will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant participants will receive a second induction with inotuzumab for B-cell precursor ALL or with FLAG-Ida (fludarabine, cytarabine, idarubicin and granulocyte colony stimulating factor) for T-cell precursor ALL.
B-cell precursor ALL participants with adequate MRD clearance after cycle 1 of blinatumomab will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.
T-cell precursor ALL participants with adequate MRD clearance after the first cycle of consolidation will receive 2 blocks of early consolidation and reinduction. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification and maintenance. The remaining patients will receive early or delayed alloHSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy (+ blinatumomab for B-cell precursor ALL) | Other | Drug: Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)Pediatric-inspired chemotherapy |
| Transplantation | Other | Procedure: Transplantationallogeneic stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- De novo ALL.
- Age 18-65 years.
- No prior treatment, except:
- Urgent leukapheresis, Urgent treatment of hyperleukocytosis with hydroxyurea, Urgent cranial irradiation (one dose) for CNS leukostasis, Urgent mediastinal irradiation for superior vena cava syndrome.
- Adequate general condition (ECOG score 0-2), or >2 if due to ALL.
Key exclusion criteria (13 listed)
- Age > 65 years.
- ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).
- Ph-positive B-cell ALL (BCR::ABL1).
- Lymphoid blast crisis of chronic myeloid leukemia.
- Patients with a history of coronary artery disease, valvular heart disease, or hypertensive heart disease, which contraindicates the use of anthracyclines.
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 |
|---|---|---|
| Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine). Blinatumomab cycles in consolidation therapy for participants with B-cell precursor ALL. | Drug | Chemotherapy (+ blinatumomab for B-cell precursor ALL) |
| Transplantationallogeneic stem cell transplantation | Procedure or surgery | Transplantation |
Primary outcome
Overall survival comparison versus previous trial
Time frame: 5 years
Comparison of time from diagnosis to death or last follow-up between the present LAL-2025 trial and the previous LAL19 trial for adult Ph-negative
5 secondary outcomes
Complete remission (CR) rate
Time frame: 4 or 8 weeks after treatment onset
MRD status after induction and consolidation
Time frame: After induction (4-8 weeks) and consolidation (16-20 weeks)
MRD variation between induction and after cycle 1 blinatumomab
Time frame: After induction (4-8 weeks) and after cycle 1 blinatumomab (8-12 weeks)
Frequency of allogeneic stem cell transplantation (alloSCT) dut to high-risk genetics
Time frame: 5 years
Effect of blinatumomab within each B-cell precursor ALL genetic subtype
Time frame: 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 2 Mar 2026.
- Webpage of the sponsor of the studyLink provided by the sponsor.
- 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.
Anna Torrent, Dr study chair
Germans Trias i Pujol Hospital
Pere Barba, Dr study chair
Hospital Vall d'Hebrón
Josep Maria Ribera, Prof study chair
Germans Trias i Pujol Hospital
95 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) and Transplantation in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 95 sites in Spain.
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 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Spain. 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.
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 Anna Torrent, Dr (+34934978987, atorrent@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival comparison versus previous trial (time frame: 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 2 Mar 2026.