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New hope for leukemia patients: immunotherapy added to standard care

NCT ID NCT07443592

Disease control Sponsor: PETHEMA Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment plan for adults up to 65 years old with a type of leukemia called Ph-negative ALL. The goal is to see if adding an immunotherapy drug called blinatumomab improves survival compared to the previous treatment plan. About 330 participants will receive different treatments based on their leukemia subtype.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like Neoplasm, Residual Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    95 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • . Hospital Clínico Universitario Virgen de la Victoria

    Málaga, Spain

  • Area Hospitalaria Juan Ramón Jimenez

    Huelva, Spain

  • Basurtuko Ospitalea

    Bilbao, Spain

  • C H Santiago de Compostela

    Santiago de Compostela, Spain

  • C. Asistencial U. de Salamanca

    Salamanca, Spain

  • C. H. Gregorio Marañón

    Madrid, Spain

  • C. H. U. de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Spain

  • Clínica Universidad Navarra

    Madrid, Spain

  • Clínica Universidad Navarra

    Pamplona, Spain

  • Complejo Asistencial de Palencia

    Palencia, Spain

  • Complejo Asistencial de Zamora

    Zamora, Spain

  • Complejo Hospitalario Pontevedra (CHUP)-Montecelo

    Pontevedra, Spain

  • Complejo Hospitalario Universitario Insular Materno Infantil de Canarias

    Las Palmas de Gran Canaria, Spain

  • Complejo Hospitalario Universitario de Ourense

    Ourense, Spain

  • Consoorcio Hospitalario Virgen de Valme

    Seville, Spain

  • Consorcio Hospitalario de Jaén

    Jaén, Spain

  • Hospital Arnau de Vilanova

    Lleida, Spain

  • Hospital Arnau de Vilanova

    Valencia, Spain

  • Hospital Central de Asturias

    Oviedo, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Clínico de Valencia

    Valencia, Spain

  • Hospital Doce de Octubre

    Madrid, Spain

  • Hospital Doctor Peset

    Valencia, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, Spain

  • Hospital General Universitario de Albacete

    Albacete, Spain

  • Hospital General de Castellón

    Castelló, Spain

  • Hospital General de Ciudad Real

    Ciudad Real, Spain

  • Hospital General de Lanzarote

    Arrecife, Spain

  • Hospital General de Segovia

    Segovia, Spain

  • Hospital General de Valencia

    Valencia, Spain

  • Hospital Infanta Leonor

    Madrid, Spain

  • Hospital Jerez de la Frontera

    Jerez de la Frontera, Spain

  • Hospital La Princesa

    Madrid, Spain

  • Hospital La Zarzuela

    Madrid, Spain

  • Hospital Lozano Blesa

    Zaragoza, Spain

  • Hospital Miguel Servet

    Zaragoza, Spain

  • Hospital Morales Meseguer

    Murcia, Spain

  • Hospital Nuestra Señora Candelaria

    Santa Cruz de Tenerife, Spain

  • Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila

    Ávila, Spain

  • Hospital Príncipe de Asturias

    Madrid, Spain

  • Hospital Puerta de Hierro

    Majadahonda, Spain

  • Hospital Puerta del Mar

    Cadiz, Spain

  • Hospital QuirónSalud

    Barcelona, Spain

  • Hospital QuirónSalud

    Málaga, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Regional Universitario de Málaga (Carlos Haya)

    Málaga, Spain

  • Hospital Ruber Juan Bravo

    Madrid, Spain

  • Hospital Río Hortega

    Valladolid, Spain

  • Hospital San Pedro

    Logroño, Spain

  • Hospital San Pedro Alcántara

    Cáceres, Spain

  • Hospital Sanchinarro

    Madrid, Spain

  • Hospital Severo Ochoa

    Leganés, Spain

  • Hospital Son Espases

    Palma de Mallorca, Spain

  • Hospital Universitari Mútua Terrassa

    Terrassa, Spain

  • Hospital Universitari Son Llàtzer

    Palma de Mallorca, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 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 Lucus Augusti

    Lugo, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Universitario Quirónsalud

    Madrid, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, Spain

  • Hospital Universitario Santa Lucía

    Cartagena, Spain

  • Hospital Universitario Torrecárdenas

    Almería, Spain

  • Hospital Universitario de Araba

    Alava, Spain

  • Hospital Universitario de Badajoz

    Badajoz, Spain

  • Hospital Universitario de Burgos

    Burgos, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario de Cruces

    Cruces, Spain

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, Spain

  • Hospital Universitario de Galdakao

    Galdakao, Spain

  • Hospital Universitario de León

    León, Spain

  • Hospital Universitario de Navarra

    Pamplona, Spain

  • Hospital Universitario de Toledo

    Toledo, Spain

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Spain

  • Hospital Vall d'Hebrón

    Barcelona, Spain

  • Hospital Virgen de la Arrixaca

    Murcia, Spain

  • Hospital Virgen de la Luz

    Cuenca, Spain

  • Hospital Virgen de la Macarena

    Seville, Spain

  • Hospital Virgen del Rocío

    Seville, Spain

  • Hospital de A Coruña

    A Coruña, Spain

  • Hospital de Fuenlabrada

    Fuenlabrada, Spain

  • Hospital de Getafe

    Getafe, Spain

  • Hospital de Sant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hospital Álvaro Cunqueiro

    Vigo, Spain

  • ICO-Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Spain

  • ICO-Hospital Germans Trias i Pujol

    Badalona, Spain

  • ICO-Hospital Joan XXIII

    Tarragona, Spain

  • ICO-Hospital Josep Trueta

    Girona, Spain

  • MD Anderson Cancer Center

    Madrid, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.