Treatment of Adult Patients with BCR-ABL Negative Acute Lymphoblastic Leukemia Using Chemotherapy or Allogeneic Stem Cell Transplant Based on MRD and Genetics

What this Trial Is About

Researchers are studying adults aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph-negative ALL. The study evaluates treatment outcomes based on measurable residual disease MRD status and genetic testing done at the start. The goal is to tailor therapy after initial consolidation to improve survival and remission rates. Patients initially receive a four-drug induction chemotherapy regimen including vincristine, prednisone, pegylated asparaginase, and daunorubicin. Those who do not respond may receive a second induction with fludarabine, cytarabine, G-CSF, and idarubicin. Patients with good MRD clearance and favorable genetics continue with early and delayed consolidation, reinduction, and maintenance chemotherapy using pediatric-type protocols. Others may proceed to allogeneic hematopoietic stem cell transplantation alloHSCT. Participants will undergo regular assessments of MRD after induction and consolidation phases, along with monitoring for complete remission at 4 to 8 weeks. Researchers will track overall survival for 3 years. Safety and treatment responses are evaluated throughout, with ongoing follow-up. The total study duration includes treatment periods and observation to assess long-term outcomes under the guidance of the PETHEMA Foundation.

Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults