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Not yet recruiting NCT07443592

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

No phase Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL), Transplantation.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Participants will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).

Resistant participants will receive a second induction with inotuzumab for B-cell precursor ALL or with FLAG-Ida (fludarabine, cytarabine, idarubicin and granulocyte colony stimulating factor) for T-cell precursor ALL.

B-cell precursor ALL participants with adequate MRD clearance after cycle 1 of blinatumomab will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.

T-cell precursor ALL participants with adequate MRD clearance after the first cycle of consolidation will receive 2 blocks of early consolidation and reinduction. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification and maintenance. The remaining patients will receive early or delayed alloHSCT.

Interventions

  • Drug Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)
    Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine). Blinatumomab cycles in consolidation therapy for participants with B-cell precursor ALL.
  • Procedure Transplantation
    allogeneic stem cell transplantation

Primary outcome measures

  • Overall survival comparison versus previous trial [Time frame: 5 years]
Secondary outcome measures (5)
  • Complete remission (CR) rate [Time frame: 4 or 8 weeks after treatment onset]
  • MRD status after induction and consolidation [Time frame: After induction (4-8 weeks) and consolidation (16-20 weeks)]
  • MRD variation between induction and after cycle 1 blinatumomab [Time frame: After induction (4-8 weeks) and after cycle 1 blinatumomab (8-12 weeks)]
  • Frequency of allogeneic stem cell transplantation (alloSCT) dut to high-risk genetics [Time frame: 5 years]
  • Effect of blinatumomab within each B-cell precursor ALL genetic subtype [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 95 centers
  • Hospital de A Coruña — A Coruña
  • Hospital Universitario de Araba — Alava
  • Hospital General Universitario de Albacete — Albacete
  • Hospital General Universitario Dr. Balmis — Alicante
  • Hospital Universitario Torrecárdenas — Almería
  • Hospital General de Lanzarote — Arrecife
  • Hospital Nuestra Señora de Sonsoles / Complejo Asistencial de Ávila — Ávila
  • Hospital Universitario de Badajoz — Badajoz
  • … and 87 more centers

Identifiers

NCT: NCT07443592 · PETHEMA LAL-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗