The comparison of effectiveness and safety between different biosimilars of G‐CSF in the mobilization of peripheral blood stem cells (PBSCs) for autologous transplantation (autologous peripheral blood stem cell transplantation, auto‐PBSCT)

2019 ◽  
Vol 35 (1) ◽  
pp. 4-8
Author(s):  
Katarzyna Wicherska‐Pawłowska ◽  
Justyna Rybka ◽  
Iwona Prajs ◽  
Katarzyna Szmigiel ◽  
Joanna Tyc ◽  
...  
Blood ◽  
2011 ◽  
Vol 118 (8) ◽  
pp. 2362-2365 ◽  
Author(s):  
Bernd Hartz ◽  
Thorsten Volkmann ◽  
Sebastian Irle ◽  
Cordula Loechelt ◽  
Andreas Neubauer ◽  
...  

Abstract Rapidness of leukocyte engraftment in patients receiving peripheral blood stem cell transplantation is clinically important because the risk of fatal opportunistic infections increases with time to engraftment. Adhesion receptor molecules on hematopoietic stem cells (HSCs) have been shown to modulate homing and engraftment of HSCs. Therefore, we correlated expression levels of α4 (CD49d) and α6 (CD49f) integrins in the CD34+ HSC compartment with time to engraftment. Leukapheresis products from 103 patients were retrospectively analyzed for CD34, CD38, CD3, CD49f, and CD49d surface molecules by multiparameter flow cytometry. High expression levels of α4 integrin, but not α6 integrin on CD34+ cells, were associated with regular engraftment of leukocytes (days 8-19), whereas low surface expression correlated with delayed recovery (> 19 days; P < .0005). We show that α4 integrin expression levels on HSCs in leukapheresis products predict the engraftment capacity of mobilized peripheral blood stem cells in peripheral blood stem cell transplantation patients.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2432-2432
Author(s):  
Mark J. Bishton ◽  
Richard Lush ◽  
Nigel H. Russell ◽  
Bronwen E. Shaw ◽  
Andrew P. Haynes

Abstract Introduction: High-dose therapy with stem cell transplantation following salvage chemotherapy has an established role in the management of both Hodgkin’s disease (HD) and non-Hodgkin’s lymphoma (NHL). Peripheral blood stem cells are preferred as their use gives more rapid haemopoietic engraftment with associated reductions in both antibiotic and blood product usage and reduced length of in-patient stay. There are several combination chemotherapy regimens currently in use for salvage treatment and PBSC mobilisation in patients with relapsed or refractory lymphoma. The combination of Ifosphamide 3g/m2/day D1-3, Etoposide 200mg/m2/day D1-3 & Epirubicin 50mg/m2 D1 (IVE) has shown a high response rate in patients with both relapsed or refractory NHL and HD, and we report our experience of the IVE regimen in lymphoma patients considered for transplantation. Methods: Eligible patients with relapsed or primary refractory/progressive lymphoma were treated with 1–3 cycles of IVE at 4 weekly intervals, with the intent to proceed to either autologous or allogeneic stem cell transplantation only if they demonstrated a response. Peripheral blood stem cells were collected following G-CSF support if prior bone marrow biopsy was clear of lymphoma, with a target of 5×106/kg CD34 +ve stem cells. Responses to treatment were assessed using standard CT criteria. Results: 143 patients (93 male 50 female) were treated, with a median age of 49.9 years (19.3–66.88). Histological sub-types of lymphoma included follicular (38 patients), diffuse large B cell (31), Hodgkin’s disease (29), transformed follicular (19), mantle cell (14), high grade T cell (10) and small lymphocytic (2). Grade IV neutropenia was seen in 113 patients (79.6%) and in 77/270 patient cycles intra-venous antibiotic treatment was required. Treatment in 10 patients, in 14 cycles, was thought to be complicated by Ifosphamide encephalopathy. A major response (CR/PR) to IVE was seen in 115 patients (80.4%), with response rates of 93.1% for HD and 78% for NHL. 130 patients proceeded to stem cell mobilisation (90.9%), with a median collection of 7.86×106/kg CD34+ stem cells. 129 mobilised in excess of 2×106/kg and 64 (50.7%) mobilised greater than 5×106/kg on their first collection. 128 patients went on to transplantation (104 autologous and 24 allogeneic), with an estimated overall survival (OS) of 53% and event free survival (EFS) of 42% at 5 years. Sub group analysis showed a 5 year OS and EFS in HD of 62% and 52% respectively, while NHL showed a 5 year OS of 50% and 39% respectively. Conclusions: We conclude that IVE is a very effective salvage protocol across a wide range of lymphomas, with response rates comparing very favourably with those seen in other regimens. It is also an excellent peripheral blood stem cell mobilising regimen with predictable kinetics, with a high number of patients progressing to stem cell transplantation. Furthermore it is well tolerated with little cardiac or renal toxicity and minimal encephalopathy.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 5084-5084
Author(s):  
Quanyi Lu ◽  
Xiaoqing Niu ◽  
Peng Zhang ◽  
Delong Liu

Abstract Increasing number of patients in China have difficulty of finding sibling donors due to limited number of siblings. We therefore explored the feasibility using haploidentical parent donors for allogeneic hematopoietic stem cell transplantation. Eight leukemia patients were studied in our hospital. These included 2 CML-BC, 2 MDS-RAEB, 3 relapsed ALL and 1 relapsed AML. The median age was 12 (7–17). GCSF- mobilized bone marrow and peripheral blood stem cells were collected from parents (1 to 3 locus mismatched). The conditioning regimen consisted of fludarabine (30mg/m2/d x5), bulsulfan (4mg/kg/d x3) and cyclophosphamide (50mg/kg/d x2). Cyclosporin A, mycophenolate mofetil, methotrexate, and ATG were used for GVHD prophylaxis. The total number of CD34+ cell in the grafts ranged between 5–10 x 106/kg. The median follow- up was 13 months (6–24). One patient failed to engraft, the other 7 patients achieved full donor chimerism at day 28. The incidence of acute GVHD (grade II-IV) was 57.1% (4 of 7). The incidence of chronic GVHD of limited stage occurred in the same 4 patients. One patient died of lung complication at 17th month, another patient with CML-BC relapsed 10 months after transplantation. The rest 6 patients are alive without disease. These results suggested that parents could be considered as stem cell donors in the absence of alternative donors for young patients with high-risk diseases. GCSF-primed bone marrow plus peripheral blood stem cells might be beneficial to reduce the risk of GVHD for leukemia children in China. More patients are needed to further study this approach.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 502-502 ◽  
Author(s):  
Noel-Jean Milpied ◽  
Gerald Marit ◽  
Bernard Dazey ◽  
Jean-Michel Boiron ◽  
Zoran Ivanovic ◽  
...  

Abstract Abstract 502 Autologous stem cell transplantation with PBSC after high-dose chemotherapy remains standard therapy for patients with symptomatic Multiple Myeloma (MM). Strategies to minimize complications could significantly reduce the morbidity of that procedure. One possibility could be to shorten the duration of induced neutropenia through the injection of an ex-vivo expanded graft. Nineteen patients (pts) received EVEC after high-dose Melphalan (HDM) (200 mg/m2) as the only graft. The ex-vivo expanded procedure has been described elsewhere (Boiron et al. Transfusion 2006 and Ivanovic et al. Transfusion 2006). Briefly, thawed peripheral blood CD 34+ cells collected after G-CSF mobilisation and selected with immunomagnetic devices were incubated for 10 days in a serum free medium (Maco Biotech HP01) with Stem Cell Factor (Amgen), G-CSF (Amgen) and TPO (Amgen: 7 pts; Cellgenix:12 pts). The expanded cells were then thoroughly washed and injected 48h after the HDM injection. The ex-vivo expansion lead to a median fold of 5,4 for CD34+ cells (1,3-11,8); 118 for CD33+ (1-703880); 3386 for CD14+ (4-101075); 28,5 for CD13+ (10-703880) and 13 for CFUs (6-21). The median N° of CD34+ cells injected was 14×10e6/kg (5,3-48). The results of these transplants were compared to those achieved in 38 pts who received unmanipulated PBSC after HDM. Pts and controls were matched for age, sex, stage of the disease, first line chemotherapy ( VAD or VD) status of the disease at time of transplant, year of transplant, time between diagnosis and transplant, CD34+ mobilisation technique (HD cytoxan + G-CSF or G-CSF alone) and the median N° of total nucleated cells and of CD34+ collected. The results are summarized on the table: There was no secondary neutropenia in the patients who received EVEC. With a median FU of the entire cohort of 30 m, the median OS for pts who received their first transplant with EVEC and with PBSC is 69 m and not reached respectively (p=NS), the median PFS is 18 m and 27 m (p = NS) and the median time to progression is 14 m and 15 m (p=NS). Conclusion: EVEC is feasible, safe and reduce significantly the morbidity of autologous stem cell transplantation after HDM for multiple myeloma. Disclosures: Milpied: Amgen France: Honoraria.


2002 ◽  
Vol 11 (2) ◽  
pp. 301-314 ◽  
Author(s):  
Frédéric Baron ◽  
Etienne Baudoux ◽  
Pascale Frère ◽  
Soraya Tourqui ◽  
Nicole Schaaf-Lafontaine ◽  
...  

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