A Single-Arm, Multi-Center, Retrospective Clinical Study of Cba Preconditioning Regimen for Autologous Hematopoietic Stem Cell Transplantation in Acute Leukemia

Abstract

Background: Consolidation regimens for patients with acute leukemia (AL) after complete remission (CR) include conventional chemotherapy, autologous hematopoietic stem cell transplantation (auto-HSCT), and allogeneic hematopoietic stem cell transplantation (allo-HSCT), Limited by HLA-matching donor, physical status, ages, costs, treatment-related mortality (TRM), and graft-versus-host disease (GVHD), many patients are ineligible for allo-HSCT, auto-HSCT has become a therapeutic option for first-line consolidation in AL patients. However, there is no effective preconditioning regimens followed by autologous hematopoietic stem cell transplantation for AL patients at present.

Aims: To investigate the clinical efficacy,prognosis and safety of Cladribine combined with Cytosine arabinoside (Ara-C) and Busulfan (CBA) preconditioning regimens followed by autologous hematopoietic stem cell transplantation in patients off AL.

Methods: Patients with acute leukemia patients with complete remission and negative residual lesions were selected for autologous hematopoietic stem cell transplantation using CBA (Cladribine: 5mg/m²*5d, Busulfan:130mg/m²*3d, Ara-C:1g/m²*5d) pretreatment regimen, and the therapeutic effect, transplantation complications and prognosis were observed.

Results: A total of 16 patients with acute leukemia were enrolled in the study, there were 7 males and 9 females, with a median age of 50 (19-70) years old. included 10 patients (62.5%) with acute myeloid leukemia (AML),4 patients (25%) with acute lymphoblastic leukemia (ALL) and 2 patients (12.5%) with myelodysplastic syndromes (MDS). Among whom, low risk 4 cases (25%), low risk 5 cases (31.3%), high risk 7 cases (43.7%). Hematopoietic reconstruction was achieved in all 16 patients, and the median time of neutrophil engraftment was 12 (10-33) days, and their median time of platelet engraftment was 16 (12-36) days. 6 patients (37.5%) developed lever, and positive blood cultures were identified in 3 infected patients and included 2 cases of Escherichia coli, 1cases of Corynebacterium-afermentans. 3 patients (18.8%) had digestive tract hemorrhage of different degrees, and 1 patient（6.3%）had drug-induced liver damage. All these symptoms were cured after the symptomatic treatment. With a median follow-up of 5.3(1.2-13.2) months, 2 patients (12.5%) were lost to follow-up, 4 patients (25%) had disease recurrence, and there was no transplant-associated death occurred in any of the 16 patients.

Conclusion：

For patients with acute leukemia, undergoing autologous hematopoietic stem cell transplantation. CBA pretreatment regimen has tolerable adverse reactions, can promote implantation, reduce recurrence rale, and improve the overall quality of life of patients.

Keyword: acute leukemia, autologous hematopoietic stem cell transplantation(auto-HSCT), preconditioning regimen.

No relevant conflicts of interest to declare.