scholarly journals Letermovir profilaxis allogén vérképző-őssejt transzplantációban: egy hazai centrum gyakorlati tapasztalatai

2021 ◽  
Vol 54 (3) ◽  
pp. 153-157
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Allogeneic Stem Cell Transplantation ◽  
Cytomegalovirus Infection ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Allogeneic Stem Cell Transplant ◽  
Antiviral Compound ◽  
Transplant Patients

Összefoglaló. Bevezetés: A humán cytomegalovírus infekció direkt és indirekt szövődményei napjainkban is veszélyeztetik az allogén őssejt-transzplantációval kezelt betegeket. A széles körben alkalmazott preemptív stratégia mellett előnyös lehet a kórokozó reaktivációjának megelőzése profilaktikusan adagolt vírusellenes vegyülettel. A letermovir innovatív hatásmechanizmusú, szűk spektrumú antivirális szer, mely allogén őssejt-transzplantáltak körében végzett, placebo kontrollált klinikai vizsgálatban csökkentette a cytomegalovírus infekciók gyakoriságát és javította a túlélést. A szerzők 23, allogén őssejt-transzplantált beteg retrospektív módon gyűjtött adatait ismertetik, akik a beavatkozás kapcsán letermovir profilaxisban részesültek. A betegek több mint fele akut leukémiában szenvedett, harmaduk aktív betegséggel került transzplantációra, kétharmaduk donora haploidentikus egyezést mutatott. A letermovir adagolása során 2, azt követően további 3 személyben lépett fel cytomegalovírus infekció. Szervi érintettséggel járó cytomegalovírus betegség egyetlen esetben sem alakult ki. A megfigyelési időszak során 2 fő hunyt el, cytomegalovírustól független okok miatt. Az alkalmazhatóságot korlátozó mellékhatást nem észleltek. A letermovir a mindennapi klinikai gyakorlatban is hatékonynak és biztonságosnak bizonyult az őssejt-transzplantáltak cytomegalovírus fertőzésének megelőzésére. Summary. Introduction: Direct and indirect effects of cytomegalovirus infection remain an ongoing threat to patients treated with allogeneic stem cell transplantation. In addition to the widely used preemptive approach, prevention of viral replication with a prophylactically administered antiviral drug seems to be feasible. Letermovir, a narrow-spectrum antiviral compound with an innovative mechanism of action, has been shown to decrease the incidence of cytomegalovirus infection and to improve survival in a placebo-controlled clinical trial recruiting allogeneic stem cell transplant patients. Authors present retrospectively collected data from 23 patients receiving letermovir prophylaxis as a part of their allogeneic stem cell transplantation procedure. More than half of prophylaxed individuals had acute leukemia, a third of them underwent transplantation with an active disease and two third of the cohort had a haploidentical donor. During prophylaxis 2, subsequently further 3 patients developed a cytomegalovirus infection. No organ-specific disease could be detected. Through the observational period 2 patients have died due to causes unrelated to cytomegalovirus. No side effect interfering with drug use could be revealed. In this real-life case series letermovir has been shown to be effective and safe for the prevention of cytomegalovirus infection in allogeneic stem cell transplant patients.

Incidence and Risk Factors for Thromboembolism in Patients with Hematologic Malignancies Undergoing Allogeneic and Autologous Stem Cell Transplantation.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1141-1141
Author(s):  
Nicole M. Kuderer ◽  
Alok A. Khorana ◽  
Jonathan W. Friedberg ◽  
Eva Culakova ◽  
Gordon L. Phillips ◽  
...  
Keyword(s):  
Risk Factors ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Stem Cell Transplant ◽  
Multivariate Logistic Regression Analysis ◽  
Hematologic Malignancies ◽  
Cell Transplant ◽  
Multivariate Logistic Regression ◽  
Transplant Patients

Abstract Background: Thromboembolism (TE) is a common complication of hospitalized non-transplant cancer patients. To date, the extent and impact of TE in stem cell transplant patients is unknown, in part because it is considered a low risk group given the high prevalence of thrombocytopenia. The purpose of this study is to evaluate the incidence of and risk factors for TE in cancer patients undergoing stem cell transplantation. Methods: We conducted a retrospective analysis of all discharge summaries from the 115 US academic health centers reporting to the University HealthSystem Consortium from 1995 to 2002. We identified a total of 7,087 patients with hematologic malignancies undergoing allogeneic and autologous stem cell transplantation. The incidence of and risk factors for venous and arterial TE was analyzed in univariate and multivariate logistic regression analysis with adjusted odds ratios as estimates of relative risk. Results: TE was reported in 389 (5.5%) transplant patients with 4.8% patients developing venous and 0.7% arterial TE. The incidence of TE was greater in allogeneic (6.8%) compared to autologous (4.8%) transplant patients (p<0.0001). Among those receiving allogeneic transplantations, BMT patients experienced a higher rate of TE than PBSC patients (7.5% vs 5.6%; p<0.05). In multivariate logistic regression analysis, the following clinical variables were significantly associated with TE in stem call transplant patients with hematologic malignancies: gram negative sepsis (OR=1.76; 1.02–3.02; p=0.04), gram positive sepsis (OR=1.75; 1.25–2.45; p=0.001), line infections (OR=1.48; 1.11–1.97; p=0.008), central venous catheters (OR=1.74; 1.39–2.17; P<0.0001), pulmonary disease (OR=1.87; 1.47–2.37; p<0.0001), liver disease (OR=1.31; 1.01–1.70; p=0.04) and length of stay >30 days (OR=1.66; 1.30–2.13; p<0.0001). Hodgkin’s disease (OR= 0.59; 0.37–0.94; p=0.026) was associated with a lower risk of TE. In multivariate analysis, the type of transplant failed to remain an independent risk factor for TE after controlling for other transplant complications. Conclusions: This is the first substantive report on the incidence of thromboembolism in stem cell transplant patients. We found that thromboembolic events are a frequent complication in patients with hematologic malignancies undergoing stem cell transplantation. The incidence of TE is high among most subgroups studied. Prospective studies are needed to evaluate the efficacy and safety of thromboprophylaxis in this high-risk population.

Allogeneic haemopoietic stem cell transplantation

2007 ◽  
pp. 269-282
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Allogeneic Stem Cell Transplant ◽  
Haemopoietic Stem Cell ◽  
Haemopoietic Stem Cell Transplantation ◽  
Reduced Intensity

Principles 270 Complications of allogeneic transplant 274 Reduced intensity conditioning (RIC) transplants 280 An allogeneic stem cell transplant is where the source of haemopoietic (blood forming) stem cells is from someone other than the patient. There are a number of reasons why an allogeneic stem cell transplant may be useful:...

Preliminary Data on Once-Daily IV Busulfan at 3.2 mg/kg/day Indicate That It Is Safe as a Component of the Conditioning Regimen for Hematopoietic Stem Cell Transplantation.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5033-5033
Author(s):  
Mark W. Brunvand ◽  
Robert Rifkin ◽  
Jeffry V. Matous ◽  
Peter McSweeney ◽  
Scott Bearman
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Hematological Malignancies ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Transplant Patients ◽  
Daily Dose ◽  
Cell Transplants ◽  
Related Mortality

Abstract Busulfan is a useful chemotherapy in many stem cell transplant regimens. Data support the use of buslfan in transplant patients, especially if they have had prior treatment with radiation therapy. The dose of the busulfan used in myloablative stem cell transplantation has traditionally been sixteen oral doses of 1mg/kg/dose. The oral dosing has been limited by unreliable oral absorption of busulfan tablets. Transplant related mortality and incidence of venocclusive disease are directly related to high peak levels of busulfan. Relapse has been associated with low peak levels of busulfan. Recently, busulfan has become available as an IV preparation and preliminary data indicate that the peak busulfan levels are predictable via the IV administration route. The bulk of the data available on outcomes after transplantation using IV busulfan have used a QID dosing schedule of 0.8mg/kg/dose for sixteen doses. A smaller data base has utilized IV busulfan for stem cell transplantation as a single daily dose of 3.2mg/kg/day for 2–4 days. We present data on 19 patients treated at RMBMTP for hematological malignancies with the 3.2mg/kg/day dosing for stem cell transplantation. Sixteen of the 19 patients underwent allogeneic stem cell transplantation from related or unrelated donors from April 2003 to March 2004. Three patients underwent autologous stem cell transplants using the IV busulfan 3.2 mg/kg/day with cyclophosphamide 120 mg/kg total dose. None of the autologous transplant patients developed VOD or death during the first 100 days. 8 of the 16 patients undergoing allogeneic stem cell transplant have died: 4 patients died of relapsed disease, 2 died of GVHD, 1 patient died of sepsis, and 1 died of GVHD, relapse and a fungal infection. No autologous or allogeneic stem cell transplant patients died of regimen related toxicity. This single daily dose regimen has been well tolerated with no increase in transplant related mortality or VOD. The 3.2 mg/kg/day dose appears adequate to assure engraftment of allogeneic stem cells. The patients presented had high-risk hematological malignancies. Although the followup is short, the OS survival of 100% for the autologous stem cell transplants and 50% for the allogeneic stem cell transplantation is consistent with published data for transplantation of high-risk hematological malignancies. There does not appear to be a higher transplant related mortality, GVHD or VOD rate for patients treated with busulfan at 3.2 mg/kg/day as a single dose.

Allogeneic Stem Cell Transplant Versus Tandem High-Dose Melphalan for Front-Line Treatment of Deletion 13q14 Myeloma – An Interim Analysis of the German DSMM V Trial.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 51-51 ◽  
Author(s):  
Stefan Knop ◽  
Peter Liebisch ◽  
Holger Hebart ◽  
Ernst Holler ◽  
Monika Engelhardt ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Interim Analysis ◽  
Stem Cell Transplant ◽  
High Dose ◽  
Cell Transplant ◽  
Allogeneic Stem Cell Transplant ◽  
High Dose Melphalan

Abstract Abstract 51 Background Allogeneic stem cell transplantation (allo SCT), a treatment modality based on transfer of immunocompetent donor lymphocytes offers curative potential to subjects with a variety of hematological cancers. In multiple myeloma (MM), high-dose melphalan followed by autologous stem cell transplantation (auto SCT) is adopted as a standard of care. However, it remains palliative since virtually all patients (pts) relapse and renders allo SCT an option of interest. Deletion of chromosome 13q14 (13q-) in MM has been shown to negatively impact prognosis. Therefore, improvement of therapy for 13q- pts is highly desirable. Patients and methods A prospective two-arm multi-center trial (DSMM V) was set up by our group to compare tandem high-dose melphalan 200 mg/m2 (HD Mel) with a reduced intensity conditioning allo-SCT after one cycle of HD Mel for 13q- MM. Eligibility criteria were 13q- on bone marrow FISH analysis; age up to 60 years; newly diagnosed MM in Salmon and Durie stages II and III; and measurable disease. Allocation to either treatment arm was by availability of an HLA-matched (one mismatch allowed) volunteer related (VRD) or unrelated donor (VUD). Initially, all pts received four cycles of anthracycline/dexamethasone-based induction followed by chemomobilization of peripheral blood stem cells (PBSCT) and one cycle of HD Mel. Allogeneic SCT was performed after preparation with fludarabine (30 mg/m2 for 3 consecutive days) and melphalan 140 mg/m2. ATG was administered for VUD transplants. Results 199 pts with a median age of 53 (range, 30 – 60) years were enrolled between October 2002 and March 2007 and included in this interim analysis. Sixty-seven percent had stage III disease. Allo SCT was performed in 126 of 199 pts (63%), 76 of whom (60%) received VUD allografts. The remaining 73 subjects uniformely received tandem HD Mel. Pts following allo SCT were more likely to achieve CR (59%) when compared to tandem HD Mel (32%; p=.003) within one year after end of therapy. Similarly, overall response rate was significantly higher with allo SCT (91% versus 86%; p=.003). Of note, depth of response to allo SCT was not associated with presence of acute graft-versus-host disease (GVHD): 62% CR with grades II to IV GVHD vs 58% CR with grades 0 and I (p=.75). Treatment-related mortality (TRM) at 2 years from allo SCT was 16/126 (12.7%). At a median follow up of 25 months for tandem HD Mel and 34 months for allo SCT, projected 3-year overall survival is 72% (auto) and 60% (auto/allo SCT; p=0.22), respectively. Conclusions This is the largest trial on first-line allogeneic stem cell transplant in MM so far. Our interim results show a higher CR rate in FISH 13q- subjects undergoing allo SCT when compared to tandem HD Mel. Despite a majority of allografts in our study being delivered from unrelated donors, TRM was comparable to trials confined to sibling transplants. At a relatively short follow-up, there is not yet a difference between both arms regarding OS, albeit longer follow-up may be important as previously described. This as well as analysis of the impact of donor type and chronic GVHD on outcome will be presented at the meeting. Disclosures: No relevant conflicts of interest to declare.

Improved Outcomes with Allogeneic Stem Cell Transplantation for Aplastic Anaemia Using HLA Identical Sibling Donors: The Indian Stem Cell Transplant Registry (ISCTR) Experience

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4386-4386
Author(s):  
Biju George ◽  
Manoranjan Mahapatra ◽  
Pravas Mishra ◽  
Shashikant Apte ◽  
Sharat Damodar ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Retrospective Analysis ◽  
Aplastic Anaemia ◽  
Cell Transplantation ◽  
Median Time ◽  
Allogeneic Stem Cell Transplantation ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Transplant Registry

Abstract Introduction: Allogeneic stem cell transplantation (SCT) is the best form of therapy for a young patient (< 50 years) with severe aplastic anaemia. In developing countries, there is a big time interval between diagnosis and SCT leading to increased transfusions and increased risk of infections, both of which adversely affects transplant outcome. This retrospective analysis is aimed at studying the outcomes of SCT among Indian patients with aplastic anaemia. Methodology: The Indian Stem cell transplant registry (ISCTR) is a group of transplant physicians representing about 30 active transplant centres in India. This retrospective analysis was done on data reported on 634 patients by 20 centres who reported outcomes of SCT for aplastic anaemia. Data was collected from individual medical records and databases. Analysis was done using SPSS software version 16.0 Results: Six hundred and thirty four patients [445 males and 189 females] with a median age of 21 years (range: 2 - 65) underwent allogeneic SCT between 1990 and March 2015. There were 209 children (age < 15 years). The median time from diagnosis to SCT was 5 months (range: 1 - 120) while the median number of transfusions was 20 (range: 1 - 150). All donors were HLA identical sibling or family donors; matched unrelated and haplo-identical donor transplants were excluded from this analysis. Conditioning regimen was Cyclophosphamide based (Cy/ Cy+ ATG/ Cy+ TBI/TLI) in 78 patients (12.3%) while majority received Fludarabine with Cyclophosphamide (n = 481; 75.8%) and 75 received other conditioning regimens (Flu/TBI, Flu/Bu, Bu/Cy etc). Graft source was bone marrow [BM] in 124 (19.5%) and peripheral blood stem cells in 510 patients (80.5%). Graft versus host disease (GVHD) prophylaxis predominantly consisted of Cyclosporine and methotrexate in 543 patients (85.6%). Engraftment was seen in 572 patients (90.4%) while 19 (2.9%) had primary graft failure and 43 (6.7%) expired prior to engraftment due to infection or bleeding. The median time to neutrophil engraftment was 13 days (range: 8 - 21) while platelet engraftment occurred at 13 days (range: 5 - 37). Grade II - IV acute GVHD occurred in 29.3% while grade III-IV was seen in 14.1%. Chronic GVHD was seen in 41% of evaluable patients which was limited in most patients. At a median follow up of 43 months (range: 1 - 264), 431 patients are alive. The 5 yr OS for the entire group is 66.3 + 2.0%. The OS was higher in children compared to adults (73.4 + 3.3% vs 62.8 + 2.5%; p = 0.006), better for Flu/Cy compared to Cy based conditioning (69.8 + 2.2% vs 57.8 + 5.6%; p = 0.002) and better for PBSC compared to BM (68.9 + 2.2% vs 56.1 + 4.8%; p = 0.020). There has been significant improvement in outcomes over the past 15 years [3 yr OS of 41.9 + 1.3% for 1984-1995, 40.9 + 1.2% for 1996-2000, 70.6 + 5.0% for 2001 -2005, 70.3 + 3.1% for 2006-2010 and 68.8 + 3.0% from 2011 onwards]. Conclusion: Outcomes of patients with aplastic anaemia are improving and patients have a 70% chance of getting cured with a HLA identical sibling donor transplant. The use of PBSC as graft source is not associated with inferior outcomes. Disclosures No relevant conflicts of interest to declare.

Leflunomide therapy for refractory cytomegalovirus infections in hematopoietic stem cell transplant recipients

2018 ◽  
Vol 25 (7) ◽  
pp. 1731-1737 ◽  
Author(s):  
Emily Wang ◽  
Anna S Jan ◽  
Vi P Doan ◽  
Jill B Ferguson ◽  
Jason C Yeh
Keyword(s):  
Stem Cell ◽  
Patient Population ◽  
Cytomegalovirus Infection ◽  
Transplant Patient ◽  
Stem Cell Transplant ◽  
Case Series ◽  
Cell Transplant ◽  
Allogeneic Stem Cell Transplant ◽  
Transplant Patients ◽  
Cytomegalovirus Infections

Background Currently, there are no prospective, randomized trials analyzing leflunomide for the treatment of cytomegalovirus infection or disease in allogeneic stem cell transplant patients. Objective The primary objective of this case series was to determine the clinical and virological responses of utilizing leflunomide as therapy for refractory cytomegalovirus infections, unresponsive to first-line therapy in allogeneic stem cell transplant patients. Additionally, patient and leflunomide specific characteristics were identified and determined in this descriptive case series. Methods This is a single-center, case series of adult allogeneic stem cell transplant patients with refractory cytomegalovirus infections receiving leflunomide between 1 January 2005 and 31 March 2015. Results A total of 14 patients with refractory cytomegalovirus infections received leflunomide. All patients received concurrent anti-cytomegalovirus therapy. Nine of 13 patients tested positive for phosphotransferase UL97 and/or viral DNA polymerase UL54 genotype mutations. Nine patients achieved a virological response with undetectable cytomegalovirus titers. Of the 13 patients with teriflunomide serum levels, eight patients maintained levels >40 micrograms/milliliter (mcg/mL). Common adverse effects were pancytopenia (n = 8) and elevated liver function tests (n = 4). Conclusions Despite current strategies, refractory or recurrent cytomegalovirus infection and disease remain a clinical challenge to treat in the stem cell transplant patient population. Leflunomide used in combination with other concomitant therapies use for refractory cytomegalovirus infection in clinical practice may be a safe and effective option in the allogeneic stem cell transplant patient population.

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