scholarly journals Development of an integrated model of care for allogeneic stem cell transplantation facilitated by eHealth—the SMILe study

Author(s):  
Lynn Leppla ◽  
Anja Schmid ◽  
Sabine Valenta ◽  
Juliane Mielke ◽  
Sonja Beckmann ◽  
...  

Abstract Purpose Allogeneic stem cell transplantation would benefit from re-engineering care towards an integrated eHealth-facilitated care model. With this paper we aim to: (1) describe the development of an integrated care model (ICM) in allogeneic SteM-cell-transplantatIon faciLitated by eHealth (SMILe) by combining implementation, behavioral, and computer science methods (e.g., contextual analysis, Behavior Change Wheel, and user-centered design combined with agile software development); and (2) describe that model’s characteristics and its application in clinical practice. Methods The SMILe intervention’s development consisted of four steps, with implementation science methods informing each: (1) planning its set-up within a theoretical foundation; (2) using behavioral science methods to develop the content; (3) choosing and developing its delivery method (human/technology) using behavioral and computer science methods; and (4) describing its characteristics and application in clinical practice. Results The SMILe intervention is embedded within the eHealth enhanced Chronic Care Model, entailing four self-management intervention modules, targeting monitoring and follow-up of important medical and symptom-related parameters, infection prevention, medication adherence, and physical activity. Interventions are delivered partly face-to-face by a care coordinator embedded within the transplant team, and partly via the SMILeApp that connects patients to the transplant team, who can monitor and rapidly respond to any relevant changes within 1 year post-transplant. Conclusion This paper provides stepwise guidance on how implementation, behavioral, and computer science methods can be used to develop interventions aiming to improve care for stem cell transplant patients in real-world clinical settings. This new care model is currently being tested in a hybrid I effectiveness-implementation trial.

2017 ◽  
Vol 9 (2) ◽  
Author(s):  
Duygu Mert ◽  
Hikmetullah Batgi ◽  
Alparslan Merdin ◽  
Sabahat Çeken ◽  
Mehmet Sinan Dal ◽  
...  

BK virus is a human polyoma virus. It is acquired in early childhood and remains life-long latent in the genitourinary system. BK virus replication is more common in receiving immunosuppressive therapy receiving patients and transplant patients. BK virus could cause hemorrhagic cystitis in patients with allogeneic stem cell transplantation. Hemorrhagic cystitis is a serious complication of hematopoietic stem cell transplantation. Hemorrhagic cystitis could cause morbidity and long stay in the hospital. Diagnosis is more frequently determined by the presence of BK virus DNA detected with quantitative or real-time PCR testing in serum or plasma and less often in urine. The reduction of immunosuppression is effective in the treatment of BK virus infection. There are also several agents with anti-BK virus activity. Cidofovir is an active agent against a variety of DNA viruses including poliomyoma viruses and it is a cytosine nucleotide analogue. Intravenous immunoglobulin IgG (IVIG) also includes antibodies against BK and JC (John Cunningham) viruses. Hereby, we report three cases of hemorrhagic cystitis. Hemorrhagic cystitis developed in all these three cases of allogeneic stem cell transplantation due to acute myeloid leukemia (AML). BK virus were detected as the cause of hemorrhagic cystitis in these patients. Irrigation of the bladder was performed. Then levofloxacin 1×750 mg intravenous and IVIG 0.5 gr/kg were started. But the hematuria did not decreased. In the first case, treatment with leflunomide was started, but patient died due to refractory AML and severe graft-versus-host disease after 4th day of leflunamide and levofloxacin treatments. Cidofovir treatment and the reduction of immunosuppressive treatment decreased the BK virus load and resulted symptomatic improvement in the second case. Initiation of cidofovir was planned in the third case. Administration of cidofovir together with the reduction of immunosuppression in the treatment of hemorrhagic cystitis associated with BK virus in allogeneic stem cell transplant recipients could be a good option.


2018 ◽  
Vol 19 (2) ◽  
pp. 131-136 ◽  
Author(s):  
Stefano Benvenuti ◽  
Rosanna Ceresoli ◽  
Giovanni Boroni ◽  
Filippo Parolini ◽  
Fulvio Porta ◽  
...  

Introduction: The aim of our study was to present our experience with the use of peripherally inserted central catheters (PICCs) in pediatric patients receiving autologous or allogenic blood stem-cell transplantation. The insertion of the device in older children does not require general anesthesia and does not require a surgical procedure. Methods: From January 2014 to January 2017, 13 PICCs were inserted as a central venous device in 11 pediatric patients submitted to 14 autologous or allogeneic stem-cell transplantation, at the Bone Marrow Transplant Unit of the Children’s Hospital of Brescia. The mean age of patients at the time of the procedure was 11.3 years (range 3-18 years). PICCs remained in place for an overall period of 4104 days. All PICCs were positioned by the same specifically trained physician and utilized by nurses of our stem-cell transplant unit. Results: No insertion-related complications were observed. Late complications were catheter ruptures and line occlusions (1.2 per 1000 PICC days). No rupture or occlusion required removal of the device. No catheter-related venous thrombosis, catheter-related bloodstream infection (CRBSI), accidental removal or permanent lumen occlusion were observed. Indications for catheter removal were completion of therapy (8 patients) and death (2 patients). Three PICCs are currently being used for blood sampling in follow-up patients after transplantation. Conclusions: Our data suggest that PICCs are a safe and effective alternative to conventional central venous catheters even in pediatric patients with high risk of infectious and hemorrhagic complications such as patients receiving stem-cell transplantation.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2039-2039
Author(s):  
Stephen Robinson ◽  
Christopher P Fox ◽  
Rachel M Pearce ◽  
Julia Perry ◽  
Keiren Kirkland ◽  
...  

Abstract Abstract 2039 Introduction. The role of allogeneic stem cell transplantation in the management of aggressive non-Hodgkin's lymphoma (NHL) remains to be established. Autologous stem cell transplantation (SCT) remains the standard salvage therapy for patients with diffuse large B cell lymphoma failing first line therapy although patients relapsing early after Rituximab based immunochemotherapy have a poor outcome. For patients with aggressive T cell lymphomas the role of consolidation or salvage transplant strategies also remains controversial. Reduced intensity allogeneic transplants have been employed in these diseases with variable success. In the United Kingdom the more intensive BEAM conditioning regimen has been employed prior to allogeneic stem cell transplantation in lymphoproliferative diseases. We report here the outcome of BEAM-CAMPATH conditioning prior to allogeneic stem cell transplantation for aggressive NHL as reported to the British Bone Marrow Registry. Methods. We retrospectively identified all patients reported to the BSBMT registry as having undergone an allogeneic stem cell transplant following BEAM-CAMPATH conditioning for aggressive non-Hodgkin's lymphomas. All patients received conditioning with BEAM (BCNU 300mg/m2, etoposide 800mg/m2, cytarabine 1600mg/m2, melphalan 140mg/m2) and CAMPATH-1H 10mg days -6 to -2. Cyclosporin A was administered for 90 days post transplant. Six transplant centres contributed data to this study. Results. 46 patients (27 male, 19 female) with a median age of 45 (range 17–59) at diagnosis with DLBCL (29), Burkitt's lymphoma (1) or T cell lymphoma (PTCL NOS 14, anaplastic large cell lymphoma 3, angioimmunoblastic lymphoma 1) were identified. 37 patients had stage III/IV disease at diagnosis and 56% of patients had a high or high-intermediate International Prognostic Score. They had received a median of 3 lines of prior therapy (range 1–5), 11 of 29 patients with B cell lymphomas had received Rituximab prior to transplant and 4 patients had received a prior autologous stem cell transplant. The median time from diagnosis to transplant was 11 months (range 3 months–13 years) and 22 patients had received the transplant in first response. At transplant 34 patients had chemosenstive disease and 11 patients had chemorefractory disease. Transplants from 32 siblings and 14 volunteer unrelated donors were performed using peripheral blood stem cells in 42 patients. 3 patients received a mismatched transplant. The Performance Status (PS) at transplant was good (KPS>80) in 40 of 46 patients. All patients engrafted with a median time to neutrophil recovery of 14 days (range 11–27). At last follow up 20 patients are alive with 17 in complete remission. 5 patients have died from non-relapse causes (infection 3, GVHD 1, respiratory failure 1) and 21 died following relapse of lymphoma. Acute GVHD grades II-IV developed in 7 patients and chronic GVHD in 13 (7 limited, 6 extensive) of 37 patients surviving beyond 100 days. The cumulative incidence (CI) of non-relapse mortality (NRM) was 7% at 100 days and 11% at 3 and 5 years post transplant. NRM was significantly worse for those with a poor PS, use of a VUD, prior autologous SCT and more lines of prior therapy. The relapse risk at 1 and 5 years was 51% and 53% respectively and was associated with use of a sibling donor. Disease status at transplant had no impact on the relapse rate. The progression free survival (PFS) was 41% and 36% at 1 and 5 years respectively with a trend to a higher PFS in patients under 45 years. The overall survival (OS) was 54% t 1 year and 42% at 5 years with a significantly better OS in CMV low risk transplants. Conclusion. BEAM-CAMPATH conditioning prior to allogeneic SCT is well tolerated in patients with aggressive NHL although there remains a significant relapse rate following this therapy. A significant minority of patients achieve durable disease free survival. The role of BEAM-CAMPATH allogeneic stem cell transplantation in these diseases warrants further investigation. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2121-2121
Author(s):  
Victoria T Potter ◽  
Simona Iacobelli ◽  
Anja van Biezen ◽  
Johann Maertens ◽  
Jean-Henri Bourhis ◽  
...  

Abstract Since the approval of hypomethylating agents for the treatment of myelodysplastic syndromes (MDS) increasing numbers of patients have received these agents prior to haematopoietic stem cell transplant (HSCT). A number of small studies have suggested that this approach results in similar outcomes to conventional chemotherapy. In light of this we utilised the EBMT dataset to retrospectively analyse the outcomes of hypomethylating agent (HMA) therapy compared with conventional chemotherapy (CC) or cytarabine (ara-C) alone pre-HSCT Because hypomethylating agents were approved in early 2000, we selected MDS patients who received allogeneic stem cell transplantation between 2004 and 2011 reported to EBMT. In order to include a homogeneous group of patients with blasts at time of diagnosis we included only patients classified as RAEB or RAEB-T at time of diagnosis with sufficient data on anthracycline containing chemotherapy, hypomethylating agents or cytarabine. 234 MDS patients treated with hypomethylating agents (N=77), conventional anthracycline-based chemotherapy (N=132) or cytarabine (N-25) receiving myeloablative (N=94) or reduced intensity conditioned (RIC) HSCT (140), from sibling (N=101) or matched unrelated donors (N=133) were identified. 136 (58%) male and 98 (32%) females with a median age of 56 years (range 19-69) were included. The median follow-up of the cohort was 22.1 months (95%CI 0.7-94.3). Patients with >30% blasts were excluded. Cytogenetics were abnormal in 57%, 51% and 26% of patients receiving HMA, CC and ara-C respectively(p=0.04). Of the 77 patients treated with HMA, 73 had RAEB and 4 had RAEB-T, of the 132 patients receiving CC, 117 had RAEB and 11 had RAEB-T (missing data in 4) and of the 25 patients receiving ara-C 15 had RAEB and 1 RAEB-T (missing data in 9). Overall 127 patients (54%) achieved CR prior to HSCT with more CR in the CC group (68%) than either the HMA (32%) or ara-C (48%) groups (p<0.01). A number of patients achieved partial but not complete remission (non-CR) including 22% of patients receiving CC, 48% of patients receiving HMA and 24% of patients receiving ara-C. Primary refractory disease was noted in 10%, 19% and 28% of patients in CC, HMA and ara-C groups. On univariate analysis overall survival (OS), relapse free survival (RFS), and non-relapse mortality (NRM) did not differ significantly between those receiving HMA, CC or ara-C at three years; OS (42% vs 41% vs 54%), RFS (29% vs 36% vs 49%) and NRM (26% vs 26% vs 31%) respectively. The median OS for those treated with HMA was 31 months (10-not reached) vs 18months (13-45) for CC (p=NS). Results for sibling vs unrelated donor HSCT were similar for OS, RFS and relapse with worse outcomes for URD with respect to NRM (HR 1.74 (0.98-3.11) p=0.06). No significant difference in outcomes for standard vs RIC HSCT or normal vs abnormal cytogenetics was observed. When compared to patients in remission those in non-CR had significantly worse outcomes with regard to relapse (HR 1.75 (95%CI 1.05-2.91) p=0.03) and approached significance for RFS (HR 1.47 (95%CI(0.99-2.19) p=0.06). This was not evident for OS (HR 1.29(95%CI 0.83-2.01p=NS), or NRM (HR1.12 (0.58-2.16) p=NS). Patients with primary refractory disease had significantly worse outcomes across all parameters; OS(HR 2.81(95%CI 1.74-4.56) p=<0.01), RFS (HR 2.63 95%CI 1.67-4.16) p=<0.01), relapse (HR 2.32(95%CI 1.22-4.40) p=0.01) and NRM (HR 3(95%CI1.56-5.79) p<0.01). On multivariate analysis when adjusted for CR status at transplantation those receiving CC had inferior outcomes for OS compared to those receiving HMA (HR 1.54 (0.97-2.45), p = 0.07). For patients with primary refractory disease MVA demonstrated significantly worse outcomes for OS, RFS, CIR and NRM (HR 3.4, 3, 2.62 and 3.5 respectively p<0.01 for all). Whilst the inherent limitation of retrospective data analysis are acknowledged these findings support the growing body of evidence that HMA therapy is comparable to both CC and ara-C alone when used as pre-transplant induction treatment. Disease status is clearly important for best outcomes and the results of prospective studies which clarify the ability of hypomethylating agents vs other methods to achieve this are awaited. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2083-2083
Author(s):  
Sairah Ahmed ◽  
Antonio Di Stasi ◽  
Elizabeth J. Shpall ◽  
Issa F. Khouri ◽  
Amin M. Alousi ◽  
...  

Abstract Background Donor cell derived leukemia (DCL) is a rare event after allogeneic stem cell transplantation. First described in 1971, several cases of acute myeloid leukemia (AML) or myelodysplasia (MDS) arising from donor cells have been reported. The true incidence of DCL is difficult to ascertain, however the European Group for Blood and Marrow Transplantation survey reported in 2005 an estimated rate of 124 cases per 100,000 transplants (Hernstein et al., Hematologica 2005;90:969-975). The aim of our study was to determine the incidence and natural history of DCL after allogeneic stem cell transplantation (allo-HCT). Methods We retrospectively reviewed patients that received an allo-HCT at MD Anderson from 1/1997 to 6/2012 for hematologic malignancy (n=2148) and chose to study two groups: (1) patients who had a sex mismatched allo-HCT for AML /MDS (n=433) and (2) those who received an allo-HCT for non-hodgkins lymphoma (NHL) (n=773) – subsequently these cases were reviewed for a diagnosis of AML/MDS post transplant. Donor origin of leukemic cells was confirmed by presence of donor specific sex chromosomes on conventional cytogenetic analysis or FISH studies and by donor specific microsatellite polymorphic markers on DNA analysis (chimerism studies). Demographic and disease-related data are presented in table 1. Results 9 cases of DCL were identified out of 1206 allo-HCTs done (0.7%) from 1997-2012. 4 cases were patients who received sex mismatched allo-HCTs for AML/MDS while the other 5 were patients after allo-HCT for NHL. Median age at transplant was 59 years (range 25-66 years) and median time to diagnosis of DCL was 19 months (range 4-103 months). Only 1 patient was actively treated for GVHD with corticosteroids at diagnosis of DCL. Four of 9 had monosomy 7, 1 of 9 had trisomy 8 while the remainder of patients had diploid cytogenetics. The outcome of DCL was poor with a median survival from diagnosis of 5 months (range 1-89 months). Conclusions Our analysis suggests that DCL occurs in no less than 0.7% of patients receiving allogeneic stem cell transplants for AML/MDS or NHL. While the mechanism of leukemogenesis is unclear, monosomy 7 was demonstrated in 45% of these cases. Although the number of cases analyzed is low, the overall prognosis for DCL seems poor. Cytogenetics (cyto) Recipient (R) Donor (D) Follicular lymphoma (FL) Mantle cell lymphoma(MCL) Large cell lymphoma(LCL) Overall survival (OS) Disclosures: No relevant conflicts of interest to declare.


2010 ◽  
Vol 8 (3) ◽  
pp. 337-345 ◽  
Author(s):  
Edward A. Faber ◽  
Julie M. Vose

Substantial progress has been made in the clinical management of patients with follicular lymphoma over the past 2 decades. However, the role of autologous and allogeneic stem cell transplantation in these patients remains controversial. Myeloablative chemotherapy or radioimmunotherapy supported by autologous hematopoietic cell transplantation has been shown to lead to a longer progression-free survival and, in some studies, improved survival over standard therapy. However, in the era of rituximab-based therapies used as part of induction or salvage, these historical trials may not be representative. Allogeneic stem cell transplantation offers the advantages of a tumor-free graft and some immunologic graft-versus-lymphoma effects. However, fully myeloablative transplants have high morbidity and mortality rates. Dose-reduced conditioning regimens followed by allogeneic hematopoietic cell transplantation have substantially reduced treatment-related mortality and perhaps will produce better outcomes long-term. This article outlines some historical information regarding stem cell transplantation for follicular lymphoma and discusses recent modifications that may improve outcomes, such as adding radioimmunotherapy to autologous stem cell transplantation or using alternative dose-reduced regimens that could benefit patients with reduced toxicities.


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