NCT07443592Not yet recruiting
Treatment for Ph-negative ALL for Adults up to 65 Years
Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 6 Mar 2026
- Primary completion date
- 6 Mar 2031
- Lead sponsor
- PETHEMA Foundation
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07443592
What you commit to
- Study type: Interventional
- Planned participants: 330
- From 6 Mar 2026 to the primary completion date, 6 Mar 2031
- 95 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of clinically significant pancreatitis, at the investigator's discretion (taking into account the date of the pancreatitis, its previous severity, and sequelae).
Other illness
- 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).
- Psychiatric or mental illness that prevents providing informed consent for sample submission or adequately participating in the study.
Age
- Age \> 65 years.
Other
- 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.
- Pregnancy or breastfeeding.
- Impaired general health (ECOG scores 3 and 4) not attributable to ALL.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (95)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario de Araba Coordinator of this site? Confirm its status | Alava | Spain | Unknown status |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Hospital General de Lanzarote Coordinator of this site? Confirm its status | Arrecife | Spain | Unknown status |
| Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila Coordinator of this site? Confirm its status | Ávila | Spain | Unknown status |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Ico Hospital Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital QuirónSalud Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Basurtuko Ospitalea Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Hospital San Pedro Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Hospital Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital Universitario Santa Lucía Coordinator of this site? Confirm its status | Cartagena | Spain | Unknown status |
| Hospital General de Castellón Coordinator of this site? Confirm its status | Castelló | Spain | Unknown status |
| Hospital General de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Cruces | Spain | Unknown status |
| Hospital Virgen de la Luz Coordinator of this site? Confirm its status | Cuenca | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital de Fuenlabrada Coordinator of this site? Confirm its status | Fuenlabrada | Spain | Unknown status |
| Hospital Universitario de Galdakao Coordinator of this site? Confirm its status | Galdakao | Spain | Unknown status |
| Hospital de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Unknown status |
| ICO-Hospital Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Area Hospitalaria Juan Ramón Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Consorcio Hospitalario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Hospital Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| C. H. U. de Gran Canaria Dr. Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Complejo Hospitalario Universitario Insular Materno Infantil de Canarias Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital Severo Ochoa Coordinator of this site? Confirm its status | Leganés | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| ICO Hospital Duran I Reynals Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Hospital San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Príncipe de Asturias Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario HLA Moncloa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital La Zarzuela Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| C. H. Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clínica Universidad Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Quirónsalud Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Ruber Juan Bravo Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Doce de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Clinico Universitario Virgen de La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Carlos Haya Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital QuirónSalud Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Complejo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| Hospital Central de Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Complejo Asistencial de Palencia Coordinator of this site? Confirm its status | Palencia | Spain | Unknown status |
| Hospital Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitari Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Clinica Universidad Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Complejo Hospitalario Pontevedra (CHUP)-Montecelo Coordinator of this site? Confirm its status | Pontevedra | Spain | Unknown status |
| C. Asistencial U. de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Nuestra Señora Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| C H Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital General de Segovia Coordinator of this site? Confirm its status | Segovia | Spain | Unknown status |
| Hospital Virgen de la Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Consoorcio Hospitalario Virgen de Valme Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| ICO-Hospital Joan XXIII Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
| Hospital Universitario de Torrejon Coordinator of this site? Confirm its status | Torrejón de Ardoz | Spain | Unknown status |
| Hospital General de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clínico de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Doctor Peset Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Complejo Asistencial de Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Unknown status |
| Hospital Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hospital Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.