Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL) | Drug | — | UNRESOLVED |
| Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Chemotherapy (+ blinatumomab for B-cell precursor ALL)
- description
- Pediatric-inspired chemotherapy
- interventionNames
- Drug: Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)
- type
- OTHER
- label
- Transplantation
- description
- allogeneic stem cell transplantation
- interventionNames
- Procedure: Transplantation
Primary outcomes (1)
- measure
- Overall survival comparison versus previous trial
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available