Acute Lymphoblastic LeukemiaNCT04179929
Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults
A study testing Pediatric-type of chemotherapy and allogeneic HSCT in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 108 sites in Spain.
Trial summary
After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Pediatric-type of chemotherapy and allogeneic HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 108 sitesSpain
- Study dates
- 25 Nov 2019to Feb 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 18-60 yr with de novo Ph-neg ALL
- Eastern Cooperative Oncology Group (ECOG) 0-2 (or >2 if due to ALL)
- Informed consent
Who cannot join
- Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage
- ECOG >2 not due to ALL
- Impaired cardiac, respiratory, hepatic or renal function not due to ALL
- Pregnancy
- HIV positivity
- Severe psychiatric disease
- Negative to sign informed consent.
Trial locations and contacts
108 sites in 1 country. Contact the study team or a site near you to ask about taking part.
108 sites in 1 country
Spain108 sites, 108 recruiting
- Not yet recruiting
H. A Coruña
A Coruña
Víctor Noriega Concepción
- Not yet recruiting
H Albacete
Albacete
José Santiago Bermón
- Recruiting
H. General Univ. de Alicante
Alicante
Cristina Gil
- Not yet recruiting
H. General Univ. de Alicante
Alicante
Pascual Fernández Abellán
- Recruiting
Hospital Nuestra Señora de Sonsoles
Ávila
Miguel Cabezudo
- Recruiting
Ico-Hugtip
Badalona, Barcelona, 08916
Jose Maria Ribera Santasusana, 934978987, jribera@iconcologia.net
- Not yet recruiting
Clínica Teknon
Barcelona
Pilar Vivancos
- Not yet recruiting
H del Mar
Barcelona
Eva Gimeno
- Recruiting
H. Clínic de Barcelona
Barcelona
Jordi Esteve
- Not yet recruiting
H. del Mar
Barcelona
Eugènia Abella Monreal
- Recruiting
H. Sant Pau
Barcelona
Irene García-Cadenas
- Recruiting
H. Vall d'Hebron
Barcelona
Pere Barba
- Not yet recruiting
H. Vall d'Hebron
Barcelona
Pau Abrisqueta
- Not yet recruiting
ICO-Duran i Reynals
Bellvitge
Santiago Mercadal
- Not yet recruiting
H Basurto
Bilbao
Olga Arce Fernández
- Recruiting
Hu Basurto
Bilbao
Cristina Barrenetxea
- Not yet recruiting
H. San Pedro de Alcántara
Cáceres
Juan Bergua
- Not yet recruiting
H. Jerez
Cadiz
Carmen Muñoz García
- Not yet recruiting
H. Puerta del Mar
Cadiz
Victoria Martín Reina
- Not yet recruiting
H. General de Castellón
Castelló
Raimundo García Boyero
- Not yet recruiting
H. Reina Sofía
Córdoba
Josefina Serrano López
- Not yet recruiting
H. Fuenlabrada
Fuenlabrada
Pilar Bravo
- Not yet recruiting
H Galdakao
Galdakao
Matxalen Olivares
- Not yet recruiting
H. Univ. De Getafe
Getafe
Carmen Monteserín
- Recruiting
ICO-Dr.Josep Trueta
Girona
Nazly Santos
- Not yet recruiting
H. Guadalajara
Guadalajara
Miguel Díaz Morfa
- Not yet recruiting
H Juan Ramón Jiménez
Huelva
Encarni Gil Espárraga
- Recruiting
Complejo Hospitalario Ciudad de Jaén
Jaén
Angela Baena
- Recruiting
H. Jerez de la Frontera
Jerez de la Frontera
Lourdes Hermosín
- Not yet recruiting
H. General Lanzarote
Lanzarote
Azueg Hong
- Recruiting
H Dr. Negrín
Las Palmas de Gran Canaria
Carlos Rodríguez
- Not yet recruiting
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria
Rosa Fernández
- Not yet recruiting
Hu Gran Canarias Dr Negrin
Las Palmas de Gran Canaria
Carlos Rodríguez Medina
- Recruiting
H. Arnau De Vilanova
Lleida
Antoni García Guiñón
- Not yet recruiting
H. Lucus Augusti
Lugo
Esperanza Lavilla
- Not yet recruiting
H. Lucus Augusti
Lugo
Maria José Sánchez Sánchez
- Not yet recruiting
H. Lucus Augusti
Lugo
Jesús Arias Sampedro
- Not yet recruiting
Fundación Jiménez Díaz
Madrid
José Luis López Lorenzo
- Not yet recruiting
H La Zarzuela
Madrid
Daniel García Belmonte
- Recruiting
H Puerta de Hierro
Madrid
Irene Romera
- Not yet recruiting
H Puerta de Hierro
Madrid
Rafael Forés
- Not yet recruiting
H. 12 de Octubre
Madrid
Carlos Grande
- Not yet recruiting
H. 12 de Octubre
Madrid
Pilar Martínez Sánchez
- Not yet recruiting
H. 12 de Octubre
Madrid
José María Sánchez Pina
- Not yet recruiting
H. 12 de Octubre
Madrid
María Calbacho
- Not yet recruiting
H. 12 de Octubre
Madrid
Mario Rodríguez Rodríguez
- Not yet recruiting
H. Clínico de Madrid
Madrid
Eloy del Potro
- Not yet recruiting
H. Clínico de Madrid
Madrid
Mónica Sánchez
- Not yet recruiting
H. Gregorio Marañón
Madrid
Silvia Monsalvo
- Not yet recruiting
H. Gregorio Marañón
Madrid
Mariana Bastos Oreiro
- Not yet recruiting
H. Infanta Sofía
Madrid
Pilar Massó
- Recruiting
H. Madrid-Norte Sanchinarro
Madrid
Alfons Serrano
- Recruiting
H. Ramón y Cajal
Madrid
Alberto González
- Not yet recruiting
H. Ramón y Cajal
Madrid
Anabelle Chinea
- Not yet recruiting
H. Univ La Paz
Madrid
Dolores Hernández Maraver
- Not yet recruiting
Hu Infanta Leonor
Madrid
María José Penalva Moreno
- Not yet recruiting
Hu La Princesa
Madrid
Reyes Arranz
- Not yet recruiting
H. Carlos Haya
Málaga
Concha Bethencourt
- Recruiting
H. Clínico Univ. Virgen de la Victoria
Málaga
MªPaz Queipo de Llano
- Recruiting
H. Regional de Málaga
Málaga
Alejandro Contento
- Not yet recruiting
H. Morales Meseguer
Murcia
Maria Luz Amigo Lozano
- Not yet recruiting
H. Virgen de la Arrixaca
Murcia
José Maria Moraleda
- Not yet recruiting
H. Virgen de la Arrixaca
Murcia
Andrés Sánchez Salinas
- Not yet recruiting
H. Virgen de la Arrixaca
Murcia
Maria Carmen Garcia Garay
- Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
María Elsa López Ansoar
- Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
Manuel Albors Ferreiro
- Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
Marta Rodríguez
- Not yet recruiting
Complejo Hosp. Univ. de Orense
Ourense
José Angel Méndez Sánchez
- Recruiting
H. Central de Asturias
Oviedo
Teresa Bernal
- Not yet recruiting
H Río Carrión
Palencia
José María Alonso Alonso
- Recruiting
H. Son Espases
Palma de Mallorca
Andrés Novo
- Not yet recruiting
H. Son Llàtzer
Palma de Mallorca
Antònia Cladera
- Recruiting
Complejo Hospitalario Navarra
Pamplona
M Carmen Mateos
- Not yet recruiting
H. Clínico Univ. de Navarra
Pamplona
José Rifón
- Not yet recruiting
H. Virgen del Camino
Pamplona
Maria Carmen Mateos Rodríguez
- Not yet recruiting
Complejo Hospitalario Pontevedra - Hospital Montecelo
Pontevedra
Maria Lourdes Amador
- Not yet recruiting
H. Parc Taulí
Sabadell
Sonia Piernas
- Not yet recruiting
H. Clínico Univ. de Salamanca
Salamanca
Mónica Cabrero
- Not yet recruiting
H. Clínico Univ. de Salamanca
Salamanca
Jesús Mª Hernández Rivas
- Not yet recruiting
H Donostia
San Sebastián
Maria Teresa Artola
- Not yet recruiting
H Donostia
San Sebastián
Nerea Caminos Uresandi
- Not yet recruiting
H Donostia
San Sebastián
Izaskun Ceberio
- Not yet recruiting
H Donostia
San Sebastián
Maialen Sirvent Auzmendi
- Not yet recruiting
H. Univ. de Canarias
Santa Cruz de Tenerife
Beatriz Soria Santa Bárbara
- Not yet recruiting
H. Marqués de Valdecilla
Santander
Mercedes Colorado
- Not yet recruiting
H. Marqués de Valdecilla
Santander
Arancha Bermúdez
- Not yet recruiting
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela
Maria José Rabuñal Martínez
- Recruiting
Complejo Hosp. Univ. Santiago de Compostela
Santiago de Compostela
Natalia Alonso
- Not yet recruiting
H. General de Segovia
Segovia
José Antonio Queizán Hernández
- Not yet recruiting
H. Universitario de Valme
Seville
Carmen Couto
- Recruiting
H. Virgen del Rocío
Seville
José González Campos
- Not yet recruiting
ICO-Joan XXIII
Tarragona
Marta Cervera
- Not yet recruiting
Mútua de Terrassa
Terrassa
Ferran Vall-Llovera Calmet
- Not yet recruiting
H Torrejón
Torrejón de Ardoz
Ana Sebrango Sadia
- Not yet recruiting
H. Verge de la Cinta
Tortosa
Xavier Ortin Font
- Not yet recruiting
H. Arnau de Vilanova
Valencia
Aurelio López
- Not yet recruiting
H. Clínico Univ. de Valencia
Valencia
Mar Tormo
- Not yet recruiting
H. Dr. Peset
Valencia
María José Sayas
- Not yet recruiting
H. Dr. Peset
Valencia
María Pedreño
- Not yet recruiting
H. General Univ. de Valencia
Valencia
Magdalena Sánchez
- Recruiting
H. la Fe
Valencia
Pau Montesinos
- Not yet recruiting
H. Clínico Universitario de Valladolid
Valladolid
María Jesús Peñarrubia
- Not yet recruiting
H. Río Hortega
Valladolid
Alberto Cantalapiedra
- Not yet recruiting
H. Xeral-Cíes Vigo
Vigo
Ángeles Fernández Fernández
- Not yet recruiting
H. Xeral-Cíes Vigo
Vigo
Esmeralda Benítez
- Not yet recruiting
H. Virgen de la Concha
Zamora
Magdalena Sierra Pacho
- Not yet recruiting
H. Lozano Blesa
Zaragoza
Mayte Olave
- Not yet recruiting
H. Miguel Servet
Zaragoza
Beatriz de Rueda
About this study
Official title: Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.
Read the detailed description
Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA).
Patients with adequate MRD clearance after induction 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Pediatric-type of chemotherapy, allogeneic HSCT
- Keywords
- ALL, adult, Ph-negative, minimal residual disease, 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 chemotherapyDrug
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)
allogeneic HSCTProcedure or surgery
allogeneic HSCT
| Study group | Role | What they receive |
|---|---|---|
| CHEMOTHERAPY | Other | Pediatric-type of chemotherapy Receives: Drug: Pediatric-type of chemotherapy |
| allogeneic HSCT | Other | allogeneic HSCT Receives: Procedure: allogeneic HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from diagnosis to death or last follow-up
Measured: 3 years
Secondary outcomes (2)
Complete remission (CR) rate
Proportion of patients 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 patients who achieve and maintain the negative MRD status (<10-4)
Measured: After induction (4-8 weeks) and consolidation (16-20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start25 Nov 2019
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179929
- Sponsor's protocol ID
- PETHEMA LAL-2019
- Status last verified
- Feb 2022
- First submitted
- 20 Nov 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ribera JM, Torrent A, Morgades M, Barrena S, Ribera J, Genesca E, Gonzalez-Campos J, Martinez-Cibrian N, Montesinos P, Hernandez Sanchez A, Barba P, Zapico E Sr, Sanchez R, Novo A, Sitges M, Maluquer Artigal C, Such E, Botella C, Queipo de Llano MP, Cabrero M, Vicent A, Lopez de Ugarriza P, Tormo M, Gonzalez-Gonzalez BJ, Garcia-Cadenas I, Rodriguez-Medina C, Martinez Sanchez P, Bermudez A, Gomez-Centurion I, Herrero-Garcia M, Ciudad J, Navas-Acosta J, Hermosin L, Serrano J, Raposo-Puglia JA, Solan L, Roldan-Galiacho V, de Laiglesia A, Gomez-Perez L, Sole-Rodriguez M, Casado MS Sr, Llorente Gonzalez L, Barrios Decoud D, Vall-Llovera F, Algarra JL, Amador L, Garcia-Boyero R, Cladera A, Bergua Burgues JM, Calasanz MJJ, Granada I, Feliu E, Hernandez-Rivas JM, Orfao A. Genetics and MRD for therapy allocation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Blood. 2026 May 4:blood.2025032645. doi: 10.1182/blood.2025032645. Online ahead of print.
PubMed 42081455
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
- ClinicalTrials.gov ID
- NCT04179929
- Acronym / sponsor ID
- PETHEMA LAL-2019
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, adult, Ph-negative, minimal residual disease, transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Nov 2019 (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.
After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.
Detailed description
Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA).
Patients with adequate MRD clearance after induction 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHEMOTHERAPY | Other | Drug: Pediatric-type of chemotherapyPediatric-type of chemotherapy |
| allogeneic HSCT | Other | Procedure: allogeneic HSCTallogeneic HSCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients 18-60 yr with de novo Ph-neg ALL
- Eastern Cooperative Oncology Group (ECOG) 0-2 (or >2 if due to ALL)
- Informed consent
Key exclusion criteria (7 listed)
- Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage
- ECOG >2 not due to ALL
- Impaired cardiac, respiratory, hepatic or renal function not due to ALL
- Pregnancy
- HIV positivity
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 chemotherapyPediatric 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) | Drug | CHEMOTHERAPY |
| allogeneic HSCTallogeneic HSCT | Procedure or surgery | allogeneic HSCT |
Primary outcome
Overall survival
Time frame: 3 years
Time from diagnosis to death or last follow-up
2 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)
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 18 Feb 2022.
- Derived from this study: PubMed 42081455Ribera JM, Torrent A, Morgades M, Barrena S, Ribera J, Genesca E, Gonzalez-Campos J, Martinez-Cibrian N, Montesinos P, Hernandez Sanchez A, Barba P, Zapico E Sr, Sanchez R, Novo A, Sitges M, Maluquer Artigal C, Such E, Botella C, Queipo de Llano MP, Cabrero M, Vicent A, Lopez de Ugarriza P, Tormo M, Gonzalez-Gonzalez BJ, Garcia-Cadenas I, Rodriguez-Medina C, Martinez Sanchez P, Bermudez A, Gomez-Centurion I, Herrero-Garcia M, Ciudad J, Navas-Acosta J, Hermosin L, Serrano J, Raposo-Puglia JA, Solan L, Roldan-Galiacho V, de Laiglesia A, Gomez-Perez L, Sole-Rodriguez M, Casado MS Sr, Llorente Gonzalez L, Barrios Decoud D, Vall-Llovera F, Algarra JL, Amador L, Garcia-Boyero R, Cladera A, Bergua Burgues JM, Calasanz MJJ, Granada I, Feliu E, Hernandez-Rivas JM, Orfao A. Genetics and MRD for therapy allocation in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Blood. 2026 May 4:blood.2025032645. doi: 10.1182/blood.2025032645. Online ahead of print.
- Web page 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.
108 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 and allogeneic HSCT in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 108 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 3 inclusion and 7 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 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 Josep Maria Ribera, Ph (934978987, jribera@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). 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 NCT04179929, which also lists 1 linked publication.
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 18 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.