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To date, it has not been entirely clear whether allo-HSCT (allo-HSCT) is required for patients with detectable residual lesions (MRDs) to remove fully high-risk characteristics (HR) and philadelphia chromosomal-negative (Ph-neg) acute lymphoblastic leukemia (ALL).
the ALL-HR-11 trial was to assess the outcome of chemotherapy or allo-HSCT in adult ALL patients with HR Ph-neg adults based on mrD levels after end-of-treatment induction and consolidation.
HR-ALL patients aged 15-60 who were in complete remission (CR), MRD levels after induction chemotherapy, MRD levels after early consolidation therapy, and HR-ALL patients with MRD levels after early consolidation therapy, received delayed consolidation and maintenance therapy in the CR group for up to 2 years.
the remaining patients were assigned to the alllo-HSCT group.
315 of the 348 patients who received CR (91%) after induction chemotherapy and consolidation chemotherapy (Day-14: induced chemotherapy; Day-35: induced chemotherapy; Post-C3: after early consolidation therapy) received CR (91%); and 220 of the 289 patients received MRD levels after induction chemotherapy.
, 218 patients were assigned to the chemotherapy group and 106 patients were assigned to the allo-HSCT group through intentional therapy.
5-year cumulative recurrence (CIR), total survival (OS) and event-free lifetime (EFS) probability of 43% ±7%, 49% ±7% and 4, respectively, of all patients with cumulative recurrence rate 0±6%, with CIR and OS rates of 45±8% and 59±9% respectively in the chemotherapy group and 40±12% and 38±11% respectively in the allo-HSCT group.
the results showed that the non-alllo-HSCT did not affect the prognostication of HR Ph-neg ALL under 60 years of age, induced chemotherapy and full remission of MRD after consolidation treatment.
for patients with poor MRD clearance rates, better alternative therapies are needed.