Session: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster I
Hematology Disease Topics & Pathways:
Clinical Practice (Health Services and Quality)
Methods. A centralized immunophenotypic (next-generation cytofluorometry) and genetic (FISH, SNP arrays and NGS) study was carried out in parallel with the induction-1 (Ind-1) treatment (vincristine, prednisone, PEG-asparaginase and daunorubicin). Pts without adverse genetic risk (AGR) and MRD <0.01% received 3 cycles of early consolidation (HD-MTX, HD ARAC and PEG-asparaginase) and reinduction. If MRD was <0.001% at that point, pts received 3 cycles of delayed consolidation and maintenance therapy. The remaining pts were assigned to alloHSCT. Refractory pts or those with MRD ≥0.01% after Ind-1 received a 2nd induction cycle (Ind-2) (FLAG-Ida or Inotuzumab after amendment). Pts with early T cell precursor (ETP) ALL received differentiated treatment (induction with FLAG-Ida, 3 cycles of early consolidation (HD-MTX, HD ARAC and PEG-asparaginase) and alloHSCT.
Results. Between December 2019 and March 2024, 476 valid pts were included, 245 (51%) AYA. Median age 27 (18-40 y), 150 (61%) males, CNS infiltration 19/170 (11%), leukocytes 18x10e9/L (0.4-740), B-cell precursor ALL 178 (73%), T-ALL 67 (27%, ETP 18/67, 27%), standard genetic risk (SGR) 110/187 (59%), AGR 77/187 (41%). The CR rate after Ind-1 was 83%, and after Ind-1+Ind-2 was 94%. There were two deaths in Ind-1 and five in Ind-2. Overall 74/122 (61%) showed MRD<0.01% after Ind-1. Sixty-five pts were assigned to chemotherapy (CT) (RD<0.01% after I-1 and SGR [n=41] or RD<0.01% and genetic risk (GR) not available [n=24]). The remaining were assigned to alloHSCT (AGR only [n=20], RD post Ind-1 ≥0.01% regardless of GR [n= 49] or no CR after Ind-1 [n=25]). The probability of OS at 3 yrs for AYA was 65% (95%CI: 55%-73%), vs. 63% (51%-72%) for those at 41-60 yrs (p=0.676). The cumulative incidence of relapse (CIR) at 3-years in AYA was 39% (28%-49%) vs. 43% (29%-55%) for those aged 41-60 yrs (p=0.676). The subgroup of AYA with MRD <0.01% and SGR had a probability of OS at 3-years of 84% (61%-94%), significantly higher than the remaining groups, with no significant differences between them.
Conclusions. The preliminary results in ALL pts included in the LAL-2019 protocol are comparable to those of other pediatric-inspired protocols. No differences in OS and CIR were observed when compared AYA (18-40 yrs) with adults aged 41-60 yrs. The subgroup of low-risk AYA pts had excellent survival without need for alloHSCT.
Disclosures: Torrent: Pfizer: Honoraria; Incyte: Honoraria; Kite: Honoraria; Amgen: Honoraria. Montesinos: Syndax: Consultancy; Servier: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: research support, Research Funding, Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: research support, Research Funding, Speakers Bureau; Daiichi Sankyo, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: research support, Research Funding, Speakers Bureau; Jazzpharma: Consultancy, Research Funding, Speakers Bureau; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: research support, Speakers Bureau; Glycomimetics: Consultancy; Janssen: Membership on an entity's Board of Directors or advisory committees, Other: research support, Speakers Bureau; Kura Oncology: Consultancy; Pfizer: Consultancy, Research Funding, Speakers Bureau. Barba: Autolus: Consultancy; Kite-Gielead: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Honoraria; Incyte: Honoraria; BMS: Honoraria. Hernandez Rivas: Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; GlaxoSmithKline: Consultancy, Honoraria; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Ribera: Incyte: Consultancy; Pfizer: Consultancy; Bristol Myers Squibb: Consultancy; Novartis: Consultancy; Takeda: Consultancy; Amgen: Research Funding.