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Intensive conditioning with cladribine, cytarabine, and granulocyte colony-stimulating factor (CLAG) with total body irradiation (TBI) prior to allogeneic hematopoietic stem cell transplant (allo-HSCT) may be effective among patients with relapsed/refractory acute myeloid leukemia (AML), according to a retrospective study. The results of the study were published in the Annals of Hematology.
“Intensive condition with CLAG regimens plus TBI may be an effective and well-tolerated choice for relapsed/refractory AML patients undergoing allo-HSCT,” the authors wrote in their report.
The single-center, retrospective study conducted in China analyzed data from 70 patients with relapsed/refractory AML who received CLAG plus TBI as conditioning therapy prior to undergoing allo-HSCT between 2016 and 2021. All patients received prophylaxis against graft vs host disease (GVHD) with cyclosporine A, mycophenolate mofetil, and short-course methotrexate.
The cohort included 21 patients with refractory disease and 49 who had relapsed. The median age was 32 and 47.1% of patients were female. There were 70% of patients with extramedullary disease, of which, 12.9% was located within the central nervous system.
The graft type was peripheral blood stem cells (PBSCs) only among 11.4% with the remaining patients receiving PBSCs plus bone marrow cells. There were 77.1% of patients who received haplotype donor cells, 18.6% had a matched sibling donor, and 4.3% had a matched unrelated donor.
Complete remission with negative minimal residual disease (MRD) was achieved by all evaluable patients. Relapse-free survival (RFS) at 1- and 3-years was 48.6% and 38.5%, respectively.
Overall survival (OS) rates were 62.9% at 1 year and 46.0% at 3 years. The cumulative incidence of relapse-related and nonrelapse-related mortality at 1 year was 38.6% and 11.6%, respectively.
In a multivariate analysis, OS was significantly associated with the proportion of bone marrow blasts (hazard ratio [HR], 2.69; 95% CI, 1.36-5.31; P =.005) and development of chronic GVHD (HR, 0.20; 95% CI, 0.10-0.40; P <.001). Bone marrow blasts (HR, 2.64; 95% CI, 1.42-4.92; P =.002) and chronic GVHD (HR, 0.29; 95% CI, 0.15-0.53; P <.001) were also significantly associated with RFS.
All-grade acute GVHD developed among 51.4% of patients, including 28.6% with grade I-II and 22.8% with grade III-IV. Chronic GVHD occurred among 55.7% of patients alive after day 100 with a median time of 5.0 months. Limited chronic GVHD was present among 24.3% of patients, and extensive disease was present among 31.4%. GVHD and relapse-free survival (GRFS) was 18.6% at 1 year.
“Our study demonstrated the feasibility of TBI/CLAG-based regimens as intensive conditioning chemotherapy prior to allo-HSCT in relapsed/refractory AML patients, which may achieve high complete remission rate and improve long-term survivals,” the authors concluded. “However, these findings need further validation by well-designed randomized controlled trials in the future.”
Reference
Fei X, Zhang W, Gu J, et al. CLAG combined with total body irradiation as intensive conditioning chemotherapy prior to allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed acute myeloid leukemia. Ann Hematol. Published online October 17, 2023. doi: 10.1007/s00277-023-05502-0
This article originally appeared on Hematology Advisor
