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  • 1
    In: Cytokine & Growth Factor Reviews, Elsevier BV, Vol. 30 ( 2016-08), p. 95-101
    Type of Medium: Online Resource
    ISSN: 1359-6101
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2016
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  • 2
    In: Bone Marrow Transplantation, Springer Science and Business Media LLC, Vol. 57, No. 7 ( 2022-07), p. 1116-1123
    Type of Medium: Online Resource
    ISSN: 0268-3369 , 1476-5365
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    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 3
    In: Transplant International, Frontiers Media SA, Vol. 26, No. 8 ( 2013-08), p. e64-e68
    Type of Medium: Online Resource
    ISSN: 0934-0874
    URL: Issue
    Language: English
    Publisher: Frontiers Media SA
    Publication Date: 2013
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  • 4
    In: Leukemia & Lymphoma, Informa UK Limited, Vol. 61, No. 10 ( 2020-08-23), p. 2365-2374
    Type of Medium: Online Resource
    ISSN: 1042-8194 , 1029-2403
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2020
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  • 5
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 1965-1965
    Abstract: MCL is a relatively rare, but aggressive subtype of non-Hodgkin’s lymphoma. The current standard therapeutic approach for MCL combines rituximab–containing chemotherapy, followed by autologous stem cell transplantation. Using such approach, most patients will achieve complete remission (CR). However, almost all patients will experience relapse with MCL being an uncurable disease. With this background, and given its curative potential, reduced intensity conditioning allogeneic stem cell transplantation (RIC-allo-SCT) may represent an attractive strategy in MCL. Here, we report a large multicenter retrospective analysis including 60 MCL patients who underwent RIC-allo-SCT. In this series, 43 patients were males. All patients but one, received at least one line of chemotherapy prior to RIC-allo-SCT including auto-SCT in 37 cases. The median number of previous therapies was 2 (range, 0–5). At time of RIC-allo-SCT, 26 patients were in CR, 20 in PR, while 14 were in stable/progressive or refractory disease. Median age at time of transplantation was 56 years (range, 33–67). Median time between diagnosis and transplantation was 3.5 years (range, 0.5–10). PBSCs were used in the majority of cases (n=56). HLA-identical sibling donors were used in 25 cases. HLA-mismatched or HLA-matched unrelated donors were used in the remaining 35 cases. Different RIC regimens were also used: fludarabine-busulfan-ATG in 17 cases, fludarabine and low-dose TBI in 10 cases, fludarabine-melphalan-ATG-rituximab in 6 cases, and other various regimens in 27 cases. In all, the RIC regimen included low-dose TBI in 14 cases, fludarabine in 56 cases and ATG in 34 cases. The median follow-up for surviving patients was 2 years (range, 0.1–8.5). Fifteen patients died of non-relapse-related causes, while 6 patients did not engraft. Disease-related deathes accounted for 6 cases. The 3-years OS estimate was 47% (95%CI, 31–60). According to disease status at transplantation, the 3-years OS estimates for patients who reached CR were 59% (95%CI, 34–77) as compared to 36%(95%CI, 8–65.5) for patients who reached PR and 17% (95%CI, 1– 49) for all others (P=0.001). According to disease status at transplantation (excluding those patients who failed to engraft), the 3-years EFS estimates for patients who reached CR were 68.5% (95%CI, 42–85) as compared to 45% (95%CI, 15–72) for patients who reached PR and 21% (95%CI, 1–57) for all others (P=0.005). Interestingly, the number of lines of chemotherapy administered prior to RIC-allo-SCT had no significant impact on OS and EFS Despite its retrospective nature, and the heterogeneity of the patients included in this analysis, these results suggest that RIC-allo-SCT may be an effective therapy in MCL, especially in those patients with a chemo-sensitive disease at time of transplantation, irrespective of the number of lines of prior therapy.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 6
    In: Journal of Diabetes Science and Technology, SAGE Publications, Vol. 16, No. 1 ( 2022-01), p. 144-151
    Abstract: New diagnostic and therapeutic technologies are increasingly changing the treatment of people with diabetes (PWD), along with increased usage of digital tools. To date, however, there is little data to which level and how diabetologists and PWD implement digitalization. Also, not much is known about the view of diabetologists on the current status and future developments in this respect. Method: In an online survey, diabetologists working in clinics and practices across Germany provided responses regarding their view on digitalization and the adoption of new technologies in diabetology to 56 questions. These comments reflect the opinion of several experts about the current importance and use of specific digital/technological topics. Results: Overall, 326 diabetologists took part in the survey. They reported a positive attitude (75.8%) toward new technologies and digitalization, and they see more advantages rather than disadvantages. Younger age of the diabetologists was significantly associated with a more positive attitude ( r = −0.176; P 〈 .01), and there was no gender effect ( P = .738). On average, in each practice, 5.5% of PWD are using an insulin pump for therapy, 4.8% a real-time continuous glucose monitoring system, 16.9% an intermittent scanning continuous glucose monitoring system, and 0.3% an automated insulin delivery (AID) system. With respect to digitalization, the three most important current topics are software for glucose data analysis (average rank on a scale from one to six, with one being the most important: 2.4), compatibility with other systems (2.9), and AID systems (3.8)). Conclusions: This survey, which is going to be repeated annually, showed that the diabetologists who participated predominantly have a positive attitude toward new technologies and digital applications and were aware of the associated advantages. However, perceived disadvantages need to be addressed to enable wider adoption of new technologies and digital solutions.
    Type of Medium: Online Resource
    ISSN: 1932-2968 , 1932-2968
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 7
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 19 ( 2017-07-01), p. 2157-2164
    Abstract: To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
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  • 8
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 2776-2776
    Abstract: Introduction. Autologous stem cell transplantation (ASCT) after cytoreductive induction is considered standard of care for younger patients (pts) with multiple myeloma (MM). However, 40% of pts fail to achieve remission to standard cytotoxic regimens obviously necessitating improvement. Bortezomib (Vel) is considered the most potent single agent MM therapy. Bortezomib-containing induction treatments have already been shown to be superior to vincristine, adriamycine, and dexamethasone. Methods. As previously reported, 30 pts were included in the dose finding study to determine the optimum dose of intravenous cyclophosphamide (C) in conjunction with Vel and dexamethasone (D). Here we report on the results of the planned interim analysis with an additional 70 pts up to 60 years of age with untreated MM. They were enrolled between 03/2006 and 03/2008 to receive a maximum of 3 three-week cycles of induction treatment with Vel 1.3 mg/m2 IV d1,4,8,11; D 40 mg/d d1,2,4,5,8,9,11,12; and C 900mg/m2 IV d1 before scheduled ASCT as a consolidation. Primary study objective is response rate (≥ PR) to VelCD before ASCT according to the stringent EBMT criteria. Results. Data from the first consecutively completed 100 pts (mean age, 52 years; 78% stage III) from 22 German centers were analyzed. Molecular cytogenetic analysis was available for 79% with the most frequent cytogenetic abnormalities being 13q− (34%), 17p− (14%) and t[4;14] (8%). All 100 pts (84% of whom completed three cycles) were included in the intent-to-treat analysis. Overall response rate was 79% with 11% CR and 68% PR + VGPR; only 2 subjects (2%) progressed. Typically VAD induces app. 60% response. Additionally, response by cytogenetic risk group was assessed. Response was documented in 73.5% of the subjects with 13q−, in 100% with t(4;14) and in 57.1% with 17p−. 42 SAEs were reported: 18 pts had a SAE associated with Vel, 17 had a SAE associated with C, and for 10 pts SAE associated with D was established. One patient died due to gastric hemorrhage possibly related to dexamethasone. This is a remarkably low rate of early deaths (1%) in this setting. 53% of the patients experienced grade 3 + 4 AE with leucopenia (34%), thrombocytopenia (6%), neutropenia (5%), anaemia (4%), nausea (3%) and bone pain (3%) being the most frequent. Infections of grade 3 and 4 have been reported in 2% and a low incidence of grade 3 (2%) but no grade 4 paraesthesia occurred while 13% of pts developed peripheral neuropathy (only of grades 1 and 2). Conclusion. This analysis demonstrates Bortezomib combined with D and intravenous C is a highly effective treatment regimen regardless of cytogenetic risk factors for newly diagnosed MM with acceptable toxicity. Given the importance of high-quality response prior to ASCT, VelCD is considered a very active induction regimen. Table 1. Response to study therapy (intent-to-treat set, n=100) Response to VelCD n (%) CR 11 PR + VGPR 68 MR 8 SD 11 PD 2 Table 2. Response by result of cytogenetic analysis (intent-to-treat set, n=100) Responding patients (≥ PR) N % No FISH abnormality 15/17 88.2 13q− 25/34 73.5 t(4;14) 8/8 100 17p− 8/14 57.1 Other 26/29 89.7
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 9
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 4304-4304
    Abstract: Dose-reduced conditioning followed by allogeneic stem cell transplantation (HSCT) is a potentially curative therapy in B non Hodgkin lymphomas (NHL). However, the number of patients who experienced an early relapse is significant, and the achievement of a prolonged second remission is usually a rare event. Posttransplant immunotherapy with DLI to induce graft versus lymphoma (GVL) effect is a reasonable option to prevent or treat relapse, however the risk of graft versus host disease (GvHD) is high. Since B-cells might serve as antigen presenting cells to induce GvHD, additional B-cell depleting therapy with monoclonal antibody (anti CD20) might reduce the risk of GvHD while inducing additional cytotoxicity to B-cells originating from B-cell lymphoma. In the current pilot study we investigated the feasibility of a combined rituximab (Rtx) plus DLI therapy in B-cell malignancies after allogeneic stem cell transplantation to prevent (n=10) or treat relapse (n=2). Twelve consecutive patients, 8 male and 4 female, affected by B cell malignancies and transplanted between July 2002 and February 2007, were included in this study. The median age at alloHSCT was 58 ys (range 27–64). The conditioning regimen consisted of melphalan (140 mg/m2), fludarabine (150 mg/m2) and ATG–Fresenius (30–60 mg/kg) (n=9) or busulfan (8–10 mg/kg), fludarabine (150 mg/kg) (n=3), donors were HLA identical sibling in the half of the group, with one HLA mismatched-unrelated donor. The source of stem cell was peripheral blood in all patients. Seven patients were not in disease remission at the time of HSCT. The indication of Rtx-DLI administration was prophylaxis of relapse in all but two patients. The schedule of this approach was: Rtx (375 mg/mq, in 4 consecutive weekly infusions), started at a median time of 194 dy from HSCT (range 77–895). DLI, in a single dose, was administered from a minimum of 1×105/Kg up to 5×106/Kg, after discontinuation of immuno-suppression, without signs of GvHD. Three patients developed acute GvHD after DLI, two with gastro-intestinal and one with cutaneous involvement, whereas 6/12 patients experienced chronic GvHD, limited in all but two. Two cases of bacterial and one case of Pneumocystis jirovecij pneumonia were diagnosed after the treatment, in 3 different patients. Two patients died in complete remission due to infectious complications. The median number of B-circulating lymphocytes before and after Rtx was 42/μL (range 0–477) and 4 (range 0–226) respectively, and the difference is not statistically significant in terms of incidence of infection in our group (χ2 test). After a median follow up of 21 mo (range 4–37) from the 1st Rtx infusion, 8/12 patients are alive at the last follow-up, six of them without disease, whereas 2 patients died due to progressive disease(table1). Rituximab and DLI post allogeneic HSCT seems to be a safe and effective approach to prevent early relapse in B malignancies in complete remission after allogeneic stem cell transplantation. Table 1 Pt no Indication of R-DLI Infection aGVHD cGVHD Relapse Last follow-up 1 prophylaxis pneumonia II (GI tract) n n alive in CR 2 prophylaxis n n n n alive in CR 3 prophylaxis n n n n alive in CR 4 prophylaxis n n n y alive with disease 5 prophylaxis n n lim n alive in CR 6 prophylaxis n n n n alive in CR 7 relapse n n lim y alive with disease 8 relapse n n n y dead with disease 9 prophylaxis PJP n ext n dead in CR 10 prophylaxis pneumonia n lim n dead in CR 11 prophylaxis n II (skin) lim y dead with disease 12 Prophylaxis N I (skin) ext n Alive in CR
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
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  • 10
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 415-415
    Abstract: Introduction Polyneuropathy, organomegaly, endocrinopathy, dermopathy associated with a paraproteinaemia (POEMS syndrome) is a rare paraneoplastic syndrome secondary to a plasma cell dyscrasia. Effective treatment of the underlying plasma cell dyscrasia, including ASCT, can control the disease and often dramatically control symptoms though limited data is available for ASCT in POEMS. Specific Aim The aim of this study was to describe the clinical outcome of ASCT for patients with POEMS syndrome. We wish to determine the impact of patient and disease-specific factors on prognosis and effectively measure the extent of systemic disease involvement and organ-specific responsiveness of ASCT. Methodology Patient-, disease-, and transplant-related variables were collected according to the data entries in the EBMT database, including tracking incomplete data entries from participating centers. Systemic involvement and organ-specific response to ASCT was detailed utilizing an organ involvement tool pre- and post-ASCT. Results 127 patients underwent an ASCT between 1997-2010 and satisfied the entry criteria. The median age was 50 years (range 26-69) with 51.2% ≤50 years of age. The extent of systematic disease involvement was: peripheral neuropathy in 58.6%, volume overload in 66.2%, organomegaly in 48.3%, papilledema in 19.8%, dermopathy in 46.6% and 34.5% had sclerotic bone lesions at presentation. The median time from diagnosis to ASCT was 7.5 months (range 1-346) with 31.5% of patients receiving an ASCT 〉 12 months from diagnosis. The graft source was PBSC in 100% of patients. Disease status at ASCT was: 47.5% CR/PR, 34% SD/MR/untreated and 18.4% in PD (missing information in 19% of patients). The conditioning regimen was Melphalan ≥200mg/m2 in 52.5%, Melphalan 〈 200mg/m2 in 9.3% (38.1 of data on dose is missing) and TBI-containing in only 1 patient. The total rate of engraftment at 3 months was 96.8%, with 2 patients (1.6%) dying before engraftment. Engraftment syndrome was documented in 37% of ASCT recipients including peri-engraftment fever in 23.4% & pulmonary infiltrates in 4.8%. Haematological complete response (CHR) was characterized in 25.2% with 16.5% having progressive disease or died without attaining CHR. CHR was demonstrated in13.3% at 12 month, 20% at 36 months and 23% at 60 months (median time to CHR of 8.6 months) post-ASCT. Both organ-specific & overall systemic response data is currently under analysis, including time-to-maximum response. With a median follow-up of 47.7 months (95%CI 38.3, 58.6), the non-relapse mortality at 1, 2 & 5 years was 3.3% (95%CI 0.1-6.4%), 4.4% (95%CI 0.6-8.2%) & 7.7% (1.9-13.6%), respectively. The median progression-free survival (PFS) was 106 months (95% CI 87.8, NR) with a 5-year PFS of 73.5% (95%CI 63.2-83.7%). The 5-year overall survival (OS) was 88.6% (95% CI 81.5-95.8%). The data analyzed in this study, demonstrates that ASCT can be an effective & safe therapeutic modality for patients with POEMS syndrome. Due to the systemic inflammatory nature of the condition, due care should be taken to supporting these patients through this procedure, especially in relation to engraftment syndrome. Disclosures: Nagler: Teva: Honoraria, Travel grants, research grants Other.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
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