0
selected
-
1.
Feasibility of autologous peripheral blood stem cell mobilization and harvest in adult patients with FLT3-mutated acute myeloid leukemia receiving chemotherapy combined with midostaurin: a single-center experience
Cordella, S., Parisotto, A., Bettelli, F., Morselli, M., Barbieri, E., Pozzi, S., Aquilino, A., Repaci, G., Cuoghi, A., Bresciani, P., et al
Annals of hematology. 2022
-
2.
Haploidentical, Unmanipulated Granulocyte Colony-Stimulating Factor (G-CSF)-Primed Peripheral Blood Stem Cell Transplants for Acute Myeloid Leukemia (AML) in Remission: A Single Center Experience
Luo, L., Fang, S., Zhao, S., Li, F., Zhou, Y., Guan, L., Yang, N., Gu, Z., Lin, T., Wang, F., et al
Annals of transplantation. 2019;24:367-373
Abstract
BACKGROUND Data about application of related haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) on patients with high-risk or intermediate-risk acute myeloid leukemia (AML) in the first complete remission (CR1) are lacking. In this study, we report the outcomes of using unmanipulated haploidentical allogeneic peripheral blood stem cell transplantation (haplo-PBSCT) as post-remission therapy for patients with high-risk or intermediate-risk AML in CR1. MATERIAL AND METHODS From January 2008 to July 2016, 33 patients diagnosed as high-risk or intermediate-risk AML in CR1 undergoing haplo-PBSCT in our institution were enrolled for analysis. The cumulative incidence of platelet and neutrophil recovery, the occurrence of acute graft-versus-host-disease (GVHD) and chronic GVHD, relapse and non-relapse mortality were assessed. Patients' survival rates were estimated using the Kaplan-Meier method. RESULTS The cumulative incidence of grade 2-4 acute GVHD, overall and extensive chronic GVHD was 18.2%, 9.1%, and 6.1%, respectively. 2-year probability of relapse was 9.1%. Disease-free survival and overall survival at 2 years were 72.7% and 75.8%, respectively. CONCLUSIONS Our results showed that unmanipulated haploidentical transplantation with G-CSF primed PBSC alone as a graft source could be an acceptable alternative post-remission treatment for high-risk or intermediate-risk AML patients in CR1 lacking a matched donor.
-
3.
Effectiveness of originator (Neupogen) and biosimilar (Zarzio) filgrastim in autologous peripheral blood stem cell mobilization in adults with acute myeloid leukemia: a single-center retrospective study
Nasillo, V., Paolini, A., Riva, G., Morselli, M., Potenza, L., Coluccio, V., Maccaferri, M., Colaci, E., Fantuzzi, V., Messerotti, A., et al
Leukemia & lymphoma. 2018;59(1):225-228
-
4.
Phase I trial of plerixafor combined with decitabine in newly diagnosed older patients with acute myeloid leukemia
Roboz, G. J., Ritchie, E. K., Dault, Y., Lam, L., Marshall, D. C., Cruz, N. M., Hsu, H. C., Hassane, D. C., Christos, P. J., Ippoliti, C., et al
Haematologica. 2018;103(8):1308-1316
Abstract
Acute myeloid leukemia carries a dismal prognosis in older patients. The objective of this study was to investigate the safety and efficacy of decitabine combined with the CXCR4 antagonist plerixafor in newly diagnosed older patients with acute myeloid leukemia and to evaluate the effects of plerixafor on leukemia stem cells. Patients were treated with monthly cycles of decitabine 20 mg/m(2) days 1-10 and escalating doses of plerixafor (320-810 mcg/kg) days 1-5. Sixty-nine patients were treated, with an overall response rate of 43%. Adverse karyotype did not predict response (P=0.31). Prior hypomethylating agent treatment was the strongest independent predictor of adverse overall survival (hazard ratio 3.1; 95%CI: 1.3-7.3; P=0.008) and response (14% in previously treated patients, 46% in treatment naïve; P=0.002). As expected, the most common toxicities were myelosuppression and infection. Plerixafor induced mobilization of leukemia stem and progenitor cells, but did not cause clinically significant hyperleukocytosis. Reduction in leukemia stem cells appeared to correlate with duration of response. Plerixafor can be safely added to decitabine in poor-prognosis, elderly acute myeloid leukemia patients. The maximum tolerated dose of the combination was 810 mcg/kg. While mobilization of leukemia stem cells was observed in some patients, the clinical benefit of adding plerixafor was uncertain. This trial was registered at clinicaltrials.gov identifier: 01352650.
-
5.
Iron overload is correlated with impaired autologous stem cell mobilization and survival in acute myeloid leukemia
Alva, L. C., Bacher, U., Seipel, K., Mansouri Taleghani, B., Mueller, B. U., Novak, U., Pabst, T.
Transfusion. 2018
Abstract
BACKGROUND Patients with acute myeloid leukemia (AML) undergoing consolidation with autologous stem cell transplantation (ASCT) depend on the successful mobilization of peripheral blood stem cells. However, the factors affecting the mobilization potential in AML patients and, in particular, the effect of transfusion-related iron overload on peripheral blood stem cell mobilization are largely unknown. STUDY DESIGN AND METHODS We investigated the association of varying levels of iron overload and stem cell mobilization efficacy in consecutive AML patients after two induction cycles. RESULTS A total of 113 AML patients in early first complete remission underwent the mobilization procedure. While 84 (74.3%) patients had serum ferritin levels exceeding 1000 mug/L, 26 (23.0%) patients had levels even higher than 2000 mug/L. Iron overload correlated with the number of preceding red blood cell transfusions and inversely correlated with circulating CD34+ cell levels (p = 0.04) at apheresis. Finally, the median progression-free and overall survival rates of patients with ferritin levels of higher than 2000 mug/L were shorter with 332 days versus 2156 days (p = 0.04) and 852 days versus 2235 days (p = 0.04), respectively. CONCLUSION Our data suggest that transfusion-related iron overload is suppressing the mobilization potential and is associated with inferior outcome in AML.
-
6.
Biosimilar Filgrastim (Tevagrastim, XMO2) for Allogeneic Hematopoietic Stem Cell Mobilization and Transplantation in Patients with Acute Myelogenous Leukemia/Myelodysplastic Syndromes
Danylesko, I., Sareli, R., Bloom-Varda, N., Yerushalmi, R., Shem-Tov, N., Shimoni, A., Nagler, A.
Biology of Blood & Marrow Transplantation. 2016;22(2):277-83
Abstract
Human recombinant granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen; Amgen, Thousand Oaks, CA, USA), has been widely used for the mobilization of CD34(+) hematopoietic stem cells (HSC) from healthy donors. The experience with biosimilar G-CSF agents in this area is limited. We performed a prospective study assessing Tevagrastim (biosimilar filgrastim, XMO2; Teva, Israel) for mobilization of CD34(+) peripheral blood HSC in HLA-matched healthy sibling donors for transplantation in 24 patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS) (NCT01542944). Results were compared to a historical control group of sibling donors who received filgrastim for stem cell mobilization for allogeneic stem cell transplantations in patients with AML and MDS. The healthy donors received Tevagrastim or filgrastim in a dose of 10 mug/kg body weight (BW) subcutaneously for 4 days. The target yields of CD34(+) cells was 5 x 10(6) CD34(+) cells/kg BW of the recipient. A median 10.2 x 10(6) (range, 2.52 to 35.4) and 9.35 x 10(6) (range, 3.7 to 30.6) CD34(+) cells per kg BW were collected in the Tevagrastim and filgrastim groups, respectively. All patients promptly engrafted with a median day of absolute neutrophil count (ANC) of >.5 x 10(9)/L and >1 x 10(9)/L of 13 days (range, 10 to 21) and 13.5 days (range, 10 to 22), respectively in the Tevagrastim group and 12 days (range, 10 to 18) and 13 days (range, 10 to 18) in the filgrastim group, respectively. Platelets reached counts of >20 x 10(9)/L and >50 x 10(9)/L within a median of 14 days (range, 11 to 33) and 17 days (range, 12 to 33) in the Tevagrastim group and 13 (range, 10 to 29) and 15 (range, 10 to 32) days in the filgrastim group, respectively. The donors developed only mild and transient side effects, which were not different between the Tevagrastim study group and the filgrastim historical control group. Similarly, the transplantation-related toxicities and outcomes did not differ between the patients who underwent transplantation with Tevagrastim-mobilized grafts and the filgrastim historical controls. In summary, we observed a similar yield of CD34(+) stem cell mobilization in the Tevagrastim study group and the filgrastim historical control group with similar engraftment kinetic, hematopoietic reconstitution, and transplantation outcome. Tevagrastim administration was safe with minimal side effects and toxicity not different than historical controls. The lack of significant differences for all parameters of stem cell collection, engraftment, and safety with the biosimilar XMO2 Tevagrastim demonstrate the "similarity" of the biosimilar and recombinant human G-CSF in this indication. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.