Treatment for Ph-negative ALL for Adults up to 65 Years (NCT07443592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Treatment for Ph-negative ALL for Adults up to 65 Years
Spain330 participantsStarted 2026-03-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) n…