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Clinical Trials in Spain / NCT07443592
Starting soon Not applicable

Treatment for Ph-negative ALL for Adults up to 65 Years

NCT07443592 · tracked via the Priya Life Science Spain tracker
Sponsor
PETHEMA Foundation
Phase
Not applicable
Started
2026-03-06
Last updated
2026-03-02

Condition(s) studied

Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)Transplantation

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.

Transplantation: allogeneic stem cell transplantation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
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

+ 55 more sites — see the full list on the official registry below.

More PETHEMA Foundation trials in Spain

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma Active, not recruiting
Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI) Recruiting
Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting
Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma Recruiting
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma Active, not recruiting

Other trials for the same condition

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia Recruiting
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation Recruiting
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL Active, not recruiting
Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy Recruiting
Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07443592 on ClinicalTrials.gov ↗ ← All trials in Spain