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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
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

Full criteria on ClinicalTrials.gov

Sites (95)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital de A Coruña
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A CoruñaSpainUnknown status
Hospital Universitario de Araba
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AlavaSpainUnknown status
Hospital General Universitario de Albacete
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AlbaceteSpainUnknown status
Hospital General Universitario Dr. Balmis
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AlicanteSpainUnknown status
Hospital Universitario Torrecárdenas
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AlmeríaSpainUnknown status
Hospital General de Lanzarote
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ArrecifeSpainUnknown status
Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila
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ÁvilaSpainUnknown status
Hospital Universitario de Badajoz
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BadajozSpainUnknown status
Ico Hospital Germans Trias I Pujol
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BadalonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital QuirónSalud
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BarcelonaSpainUnknown status
Hospital de Sant Pau
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
Basurtuko Ospitalea
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BilbaoSpainUnknown status
Hospital Universitario De Burgos
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BurgosSpainUnknown status
Hospital San Pedro Alcántara
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CáceresSpainUnknown status
Hospital Puerta del Mar
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CadizSpainUnknown status
Hospital Universitario Santa Lucía
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CartagenaSpainUnknown status
Hospital General de Castellón
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CastellóSpainUnknown status
Hospital General de Ciudad Real
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Ciudad RealSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Universitario de Cruces
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CrucesSpainUnknown status
Hospital Virgen de la Luz
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CuencaSpainUnknown status
Hospital Universitario de Donostia
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Donostia / San SebastianSpainUnknown status
Hospital de Fuenlabrada
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FuenlabradaSpainUnknown status
Hospital Universitario de Galdakao
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GaldakaoSpainUnknown status
Hospital de Getafe
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GetafeSpainUnknown status
ICO-Hospital Josep Trueta
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GironaSpainUnknown status
Area Hospitalaria Juan Ramón Jimenez
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HuelvaSpainUnknown status
Consorcio Hospitalario de Jaén
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JaénSpainUnknown status
Hospital Jerez de la Frontera
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Jerez de la FronteraSpainUnknown status
C. H. U. de Gran Canaria Dr. Negrín
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Las Palmas de Gran CanariaSpainUnknown status
Complejo Hospitalario Universitario Insular Materno Infantil de Canarias
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Las Palmas de Gran CanariaSpainUnknown status
Hospital Severo Ochoa
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LeganésSpainUnknown status
Hospital Universitario De Leon
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LeónSpainUnknown status
ICO Hospital Duran I Reynals
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Arnau de Vilanova
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LleidaSpainUnknown status
Hospital San Pedro
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LogroñoSpainUnknown status
Hospital Universitario Lucus Augusti
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LugoSpainUnknown status
Hospital Príncipe de Asturias
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MadridSpainUnknown status
Hospital La Princesa
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MadridSpainUnknown status
Hospital Universitario HLA Moncloa
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MadridSpainUnknown status
MD Anderson Cancer Center
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MadridSpainUnknown status
Hospital Universitario Infanta Sofia
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Sanchinarro
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MadridSpainUnknown status
Hospital La Zarzuela
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MadridSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
C. H. Gregorio Marañón
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MadridSpainUnknown status
Hospital Infanta Leonor
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MadridSpainUnknown status
Clínica Universidad Navarra
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MadridSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Quirónsalud
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MadridSpainUnknown status
Hospital Ruber Juan Bravo
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MadridSpainUnknown status
Hospital Doce de Octubre
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MadridSpainUnknown status
Hospital Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital Clinico Universitario Virgen de La Victoria
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MálagaSpainUnknown status
Hospital Regional Universitario de Malaga Carlos Haya
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MálagaSpainUnknown status
Hospital QuirónSalud
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MálagaSpainUnknown status
Hospital Virgen de la Arrixaca
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MurciaSpainUnknown status
Hospital Morales Meseguer
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MurciaSpainUnknown status
Complejo Hospitalario Universitario de Ourense
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OurenseSpainUnknown status
Hospital Central de Asturias
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OviedoSpainUnknown status
Complejo Asistencial de Palencia
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PalenciaSpainUnknown status
Hospital Son Espases
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Palma de MallorcaSpainUnknown status
Hospital Universitari Son Llatzer
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Palma de MallorcaSpainUnknown status
Clinica Universidad Navarra
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PamplonaSpainUnknown status
Hospital Universitario de Navarra
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PamplonaSpainUnknown status
Complejo Hospitalario Pontevedra (CHUP)-Montecelo
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PontevedraSpainUnknown status
C. Asistencial U. de Salamanca
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SalamancaSpainUnknown status
Hospital Universitario de Canarias
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Santa Cruz de TenerifeSpainUnknown status
Hospital Nuestra Señora Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
C H Santiago de Compostela
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Santiago de CompostelaSpainUnknown status
Hospital General de Segovia
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SegoviaSpainUnknown status
Hospital Virgen de la Macarena
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SevilleSpainUnknown status
Hospital Virgen Del Rocio
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SevilleSpainUnknown status
Consoorcio Hospitalario Virgen de Valme
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SevilleSpainUnknown status
ICO-Hospital Joan XXIII
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TarragonaSpainUnknown status
Hospital Universitari Mutua Terrassa
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TerrassaSpainUnknown status
Hospital Universitario de Toledo
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ToledoSpainUnknown status
Hospital Universitario de Torrejon
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Torrejón de ArdozSpainUnknown status
Hospital General de Valencia
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ValenciaSpainUnknown status
Hospital Clínico de Valencia
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ValenciaSpainUnknown status
Hospital Doctor Peset
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ValenciaSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hospital Arnau de Vilanova
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ValenciaSpainUnknown status
Hospital Rio Hortega
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ValladolidSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
Complejo Asistencial de Zamora
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ZamoraSpainUnknown status
Hospital Lozano Blesa
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ZaragozaSpainUnknown status
Hospital Miguel Servet
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.