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Protocol for the Treatment of BCR::ABL1-negative Acute Lymphoblastic Leukemia in Adults up to 65 Years
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Hospital de A Coruña
A Coruña, Spain
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
Start Date
March 6, 2026
Primary Completion Date
March 6, 2031
Completion Date
June 1, 2033
Last Updated
March 2, 2026
330
ESTIMATED participants
Pediatric-type of chemotherapy (+blinatumomab for B-cell precursor ALL)
DRUG
Transplantation
PROCEDURE
Lead Sponsor
PETHEMA Foundation
NCT05376111
NCT04065399
Data Source & Attribution
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