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

Starting soon · Not applicable

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT07443592

Run by

PETHEMA Foundation

People needed

330

Starts

2026-03-06

Expected to finish

2033-06-01

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 A Coruña — A Coruña, Spain

Full record on ClinicalTrials.gov

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