Treatment for Ph-negative ALL for Adults up to 65 Years
LAL-2025
Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years
1 other identifier
interventional
330
1 country
95
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedStudy Start
First participant enrolled
March 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2033
March 2, 2026
February 1, 2026
5 years
February 25, 2026
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 years
Secondary Outcomes (5)
Complete remission (CR) rate
4 or 8 weeks after treatment onset
MRD status after induction and consolidation
After induction (4-8 weeks) and consolidation (16-20 weeks)
MRD variation between induction and after cycle 1 blinatumomab
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
5 years
Effect of blinatumomab within each B-cell precursor ALL genetic subtype
5 years
Study Arms (2)
Chemotherapy (+ blinatumomab for B-cell precursor ALL)
OTHERPediatric-inspired chemotherapy
Transplantation
OTHERallogeneic stem cell transplantation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Hospital de A Coruña
A Coruña, Spain
Hospital Universitario de Araba
Alava, Spain
Hospital General Universitario de Albacete
Albacete, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario Torrecárdenas
Almería, Spain
Hospital General de Lanzarote
Arrecife, Spain
Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila
Ávila, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
ICO-Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital QuirónSalud
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Basurtuko Ospitalea
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Puerta del Mar
Cadiz, Spain
Hospital Universitario Santa Lucía
Cartagena, Spain
Hospital General de Castellón
Castelló, Spain
Hospital San Pedro Alcántara
Cáceres, Spain
Hospital General de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario de Cruces
Cruces, Spain
Hospital Virgen de la Luz
Cuenca, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain
Hospital de Fuenlabrada
Fuenlabrada, Spain
Hospital Universitario de Galdakao
Galdakao, Spain
Hospital de Getafe
Getafe, Spain
ICO-Hospital Josep Trueta
Girona, Spain
Area Hospitalaria Juan Ramón Jimenez
Huelva, Spain
Consorcio Hospitalario de Jaén
Jaén, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Spain
ICO-Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
C. H. U. de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Spain
Complejo Hospitalario Universitario Insular Materno Infantil de Canarias
Las Palmas de Gran Canaria, Spain
Hospital Severo Ochoa
Leganés, Spain
Hospital Universitario de León
León, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital San Pedro
Logroño, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
C. H. Gregorio Marañón
Madrid, Spain
Clínica Universidad Navarra
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital La Princesa
Madrid, Spain
Hospital La Zarzuela
Madrid, Spain
Hospital Príncipe de Asturias
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Ruber Juan Bravo
Madrid, Spain
Hospital Sanchinarro
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario HLA Moncloa
Madrid, Spain
Hospital Universitario Infanta Sofía
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Quirónsalud
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Puerta de Hierro
Majadahonda, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital QuirónSalud
Málaga, Spain
Hospital Regional Universitario de Málaga (Carlos Haya)
Málaga, Spain
Hospital Morales Meseguer
Murcia, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Central de Asturias
Oviedo, Spain
Complejo Asistencial de Palencia
Palencia, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Hospital Universitari Son Llàtzer
Palma de Mallorca, Spain
Clínica Universidad Navarra
Pamplona, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Complejo Hospitalario Pontevedra (CHUP)-Montecelo
Pontevedra, Spain
C. Asistencial U. de Salamanca
Salamanca, Spain
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
C H Santiago de Compostela
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
Consoorcio Hospitalario Virgen de Valme
Seville, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Virgen del Rocío
Seville, Spain
ICO-Hospital Joan XXIII
Tarragona, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Spain
Hospital Universitario de Toledo
Toledo, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital Doctor Peset
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Río Hortega
Valladolid, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Complejo Asistencial de Zamora
Zamora, Spain
Hospital Lozano Blesa
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna Torrent, Dr
Germans Trias i Pujol Hospital
- STUDY CHAIR
Pere Barba, Dr
Hospital Vall d'Hebrón
- STUDY CHAIR
Josep Maria Ribera, Prof
Germans Trias i Pujol Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 2, 2026
Study Start
March 6, 2026
Primary Completion (Estimated)
March 6, 2031
Study Completion (Estimated)
June 1, 2033
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share