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Chemotherapy with blinatumomab for adults with Philadelphia-negative acute lymphoblastic leukemia

Tests adding blinatumomab to chemotherapy in adults with acute lymphoblastic leukemia.

Plain-language title generated from the registry record
Registry title: Treatment for Ph-negative ALL for Adults up to 65 Years

Key facts

Where
A Coruña, Alava, Albacete, Alicante, Almería, Arrecife, Ávila, Badajoz, Badalona, Barcelona, Bilbao, Burgos, Cáceres, Cadiz, Cartagena, Castelló, Ciudad Real, Córdoba, Cruces, Cuenca, Donostia / San Sebastian, Fuenlabrada, Galdakao, Getafe, Girona, Huelva, Jaén, Jerez de la Frontera, L'Hospitalet de Llobregat, Las Palmas de Gran Canaria, Leganés, León, Lleida, Logroño, Lugo, Madrid, Majadahonda, Málaga, Murcia, Ourense, Oviedo, Palencia, Palma de Mallorca, Pamplona, Pontevedra, Salamanca, Santa Cruz de Tenerife, Santander, Santiago de Compostela, Segovia, Seville, Tarragona, Terrassa, Toledo, Torrejón de Ardoz, Valencia, Valladolid, Vigo, Zamora, and Zaragoza, SpainSee the 95 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07443592, who can take part

Where in Spain

  • Hospital de A CoruñaA Coruña, SpainNo longer taking part
  • Hospital Universitario de ArabaAlava, SpainNo longer taking part
  • Hospital General Universitario de AlbaceteAlbacete, SpainNo longer taking part
  • Hospital General Universitario Dr. BalmisAlicante, SpainNo longer taking part
  • Hospital Universitario TorrecárdenasAlmería, SpainNo longer taking part
  • Hospital General de LanzaroteArrecife, SpainNo longer taking part
  • Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de ÁvilaÁvila, SpainNo longer taking part
  • Hospital Universitario de BadajozBadajoz, SpainNo longer taking part
  • Ico Hospital Germans Trias I PujolBadalona, SpainNo longer taking part
  • Hospital Clinic de BarcelonaBarcelona, SpainNo longer taking part
  • Hospital de Sant PauBarcelona, SpainNo longer taking part
  • Hospital del MarBarcelona, SpainNo longer taking part
  • Hospital QuirónSaludBarcelona, SpainNo longer taking part
  • Hospital Vall d'HebronBarcelona, SpainNo longer taking part
  • Basurtuko OspitaleaBilbao, SpainNo longer taking part
  • Hospital Universitario De BurgosBurgos, SpainNo longer taking part
  • Hospital San Pedro AlcántaraCáceres, SpainNo longer taking part
  • Hospital Puerta del MarCadiz, SpainNo longer taking part
  • Hospital Universitario Santa LucíaCartagena, SpainNo longer taking part
  • Hospital General de CastellónCastelló, SpainNo longer taking part
  • Hospital General de Ciudad RealCiudad Real, SpainNo longer taking part
  • Hospital Universitario Reina SofiaCórdoba, SpainNo longer taking part
  • Hospital Universitario de CrucesCruces, SpainNo longer taking part
  • Hospital Virgen de la LuzCuenca, SpainNo longer taking part
  • Hospital Universitario de DonostiaDonostia / San Sebastian, SpainNo longer taking part
  • Hospital de FuenlabradaFuenlabrada, SpainNo longer taking part
  • Hospital Universitario de GaldakaoGaldakao, SpainNo longer taking part
  • Hospital de GetafeGetafe, SpainNo longer taking part
  • ICO-Hospital Josep TruetaGirona, SpainNo longer taking part
  • Area Hospitalaria Juan Ramón JimenezHuelva, SpainNo longer taking part
  • Consorcio Hospitalario de JaénJaén, SpainNo longer taking part
  • Hospital Jerez de la FronteraJerez de la Frontera, SpainNo longer taking part
  • ICO Hospital Duran I ReynalsL'Hospitalet de Llobregat, SpainNo longer taking part
  • C. H. U. de Gran Canaria Dr. NegrínLas Palmas de Gran Canaria, SpainNo longer taking part
  • Complejo Hospitalario Universitario Insular Materno Infantil de CanariasLas Palmas de Gran Canaria, SpainNo longer taking part
  • Hospital Severo OchoaLeganés, SpainNo longer taking part
  • Hospital Universitario De LeonLeón, SpainNo longer taking part
  • Hospital Arnau de VilanovaLleida, SpainNo longer taking part
  • Hospital San PedroLogroño, SpainNo longer taking part
  • Hospital Universitario Lucus AugustiLugo, SpainNo longer taking part
  • C. H. Gregorio MarañónMadrid, SpainNo longer taking part
  • Clínica Universidad NavarraMadrid, SpainNo longer taking part
  • Hospital Clínico San CarlosMadrid, SpainNo longer taking part
  • Hospital Doce de OctubreMadrid, SpainNo longer taking part
  • Hospital Infanta LeonorMadrid, SpainNo longer taking part
  • Hospital La PrincesaMadrid, SpainNo longer taking part
  • Hospital La ZarzuelaMadrid, SpainNo longer taking part
  • Hospital Príncipe de AsturiasMadrid, SpainNo longer taking part
  • Hospital Ramón y CajalMadrid, SpainNo longer taking part
  • Hospital Ruber Juan BravoMadrid, SpainNo longer taking part
  • Hospital SanchinarroMadrid, SpainNo longer taking part
  • Hospital Universitario Fundación Jiménez DíazMadrid, SpainNo longer taking part
  • Hospital Universitario HLA MoncloaMadrid, SpainNo longer taking part
  • Hospital Universitario Infanta SofiaMadrid, SpainNo longer taking part
  • Hospital Universitario La PazMadrid, SpainNo longer taking part
  • Hospital Universitario QuirónsaludMadrid, SpainNo longer taking part
  • MD Anderson Cancer CenterMadrid, SpainNo longer taking part
  • Hospital Puerta de HierroMajadahonda, SpainNo longer taking part
  • Hospital Clinico Universitario Virgen de La VictoriaMálaga, SpainNo longer taking part
  • Hospital QuirónSaludMálaga, SpainNo longer taking part
  • Hospital Regional Universitario de Malaga Carlos HayaMálaga, SpainNo longer taking part
  • Hospital Morales MeseguerMurcia, SpainNo longer taking part
  • Hospital Virgen de la ArrixacaMurcia, SpainNo longer taking part
  • Complejo Hospitalario Universitario de OurenseOurense, SpainNo longer taking part
  • Hospital Central de AsturiasOviedo, SpainNo longer taking part
  • Complejo Asistencial de PalenciaPalencia, SpainNo longer taking part
  • Hospital Son EspasesPalma de Mallorca, SpainNo longer taking part
  • Hospital Universitari Son LlatzerPalma de Mallorca, SpainNo longer taking part
  • Clinica Universidad NavarraPamplona, SpainNo longer taking part
  • Hospital Universitario de NavarraPamplona, SpainNo longer taking part
  • Complejo Hospitalario Pontevedra (CHUP)-MonteceloPontevedra, SpainNo longer taking part
  • C. Asistencial U. de SalamancaSalamanca, SpainNo longer taking part
  • Hospital Nuestra Señora CandelariaSanta Cruz de Tenerife, SpainNo longer taking part
  • Hospital Universitario de CanariasSanta Cruz de Tenerife, SpainNo longer taking part
  • Hospital Universitario Marqués de ValdecillaSantander, SpainNo longer taking part
  • C H Santiago de CompostelaSantiago de Compostela, SpainNo longer taking part
  • Hospital General de SegoviaSegovia, SpainNo longer taking part
  • Consoorcio Hospitalario Virgen de ValmeSeville, SpainNo longer taking part
  • Hospital Virgen de la MacarenaSeville, SpainNo longer taking part
  • Hospital Virgen Del RocioSeville, SpainNo longer taking part
  • ICO-Hospital Joan XXIIITarragona, SpainNo longer taking part
  • Hospital Universitari Mutua TerrassaTerrassa, SpainNo longer taking part
  • Hospital Universitario de ToledoToledo, SpainNo longer taking part
  • Hospital Universitario de TorrejonTorrejón de Ardoz, SpainNo longer taking part
  • Hospital Arnau de VilanovaValencia, SpainNo longer taking part
  • Hospital Clínico de ValenciaValencia, SpainNo longer taking part
  • Hospital Doctor PesetValencia, SpainNo longer taking part
  • Hospital General de ValenciaValencia, SpainNo longer taking part
  • Hospital Universitari i Politécnic La FeValencia, SpainNo longer taking part
  • Hospital Clínico Universitario de ValladolidValladolid, SpainNo longer taking part
  • Hospital Rio HortegaValladolid, SpainNo longer taking part
  • Hospital Alvaro CunqueiroVigo, SpainNo longer taking part
  • Complejo Asistencial de ZamoraZamora, SpainNo longer taking part
  • Hospital Lozano BlesaZaragoza, SpainNo longer taking part
  • Hospital Miguel ServetZaragoza, SpainNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
PETHEMA Foundation
Trial code
NCT07443592
Record updated
2 March 2026
Original description
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.Read full original descriptionShow less

Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years

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.

Inclusion: 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: History of clinically significant pancreatitis, at the investigator's discretion (taking into account the date of the pancreatitis, its previous severity, and sequelae); 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 > 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; Pregnancy or breastfeeding; Impaired general health (ECOG scores 3 and 4) not attributable to ALL.

ClinicalTrials.gov NCT07443592