scholarly journals A Phase II Study of Decitabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in High-Risk Patients with Myeloid Malignancies

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2107-2107
Author(s):  
Christopher R. D'Angelo ◽  
Aric C. Hall ◽  
Kyungmann Kim ◽  
Ryan J. Mattison ◽  
Walter L. Longo ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Chronic Gvhd ◽  
Infectious Complications ◽  
Myeloablative Conditioning ◽  
Hematopoietic Stem ◽  
Post Transplant ◽  
Risk Patients

Abstract Introduction: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only curative therapy for myelodysplastic syndrome (MDS) and high-risk acute myeloid leukemia (AML). Patients with high-risk disease have a markedly increased risk of relapse and death following transplant (Armand et al, Blood, 2014). Those who remain disease-free are at risk of severe morbidity from graft-versus- host-disease (GvHD). These issues highlight the importance of improved allo-HSCT platforms designed to reduce relapse rate without increasing risk of GvHD. Decitabine has minimal non-hematologic toxicity and proven efficacy in myeloid diseases (Blum et al, PNAS, 2010). Use of post-transplant cyclophosphamide has demonstrated improved rates of GvHD following allo-HSCT using haplo-identical donors (Bashey et al, JCO, 2013). No studies have reported on outcomes in patients undergoing decitabine immediately prior to transplantation followed by post-transplant cyclophosphamide (PTCy). We hypothesized that the combination of decitabine induction prior to transplant and PTCy would be safe and result in improved disease control with low rates of GVHD, translating into improved survival in a high-risk transplant cohort. Methods In this single-arm, single institution trial, eligible patients received 10 days of IV decitabine at 20mg/m2 no sooner than 24 days and no later than 17 days prior to conditioning. Myeloablative conditioning included fludarabine (50mg/m2 day-5-2), busulfan (IV 3.2mg/kg/day -5-2), and 4 Gy total body irradiation on day -1. Patients above age 65 received a 25% busulfan dose reduction. Patients received a fully or partially matched related bone marrow graft on day 0. GvHD prophylaxis included 50mg/kg of IV cyclophosphamide on day +3-4. Patients with fully matched donors received only PTCy while those with partially matched donors also received mycophenolate mofetil through day +35 and tacrolimus through day +180. Results We enrolled 20 patients, fifteen patients with AML and 5 with MDS. The cohort had a median age of 64 (29-73) and was predominantly male (14/20, 70%). Eight (40%) patients scored as high risk by the HSCT comorbidity index. Eighteen patients (90%) had a high or very high-risk score by the refined disease risk index. All patients received decitabine and 18/20 (90%) underwent transplantation; 2 patients did not receive a transplant due to infectious complications. The majority of patients received a haplo-identical graft (13/18, 72%), and the remaining 5 received a matched related graft. Outcomes are reported in table 2 and figure 1. There were no engraftment failures. Five patients, 3 MDS and 2 AML, are long-term survivors with median follow-up over 3 years. One patient developed donor derived MDS and required a second transplant. Most transplanted patients (13/18, 72%) survived to day 100 with a median post-transplant survival of 138 days. There were 15 deaths on study with the majority due to underlying disease. Six patients (6/20, 30%) died of infectious complications or did not receive a transplant due to infection. Incidence of grade 3-4 acute GvHD was low among those surviving at least 40 days from transplant (3/17, 17%). There were also low rates of chronic GvHD among the 12 patients alive without ongoing GvHD at day 100 (2/12, 17%). Conclusions Decitabine induction followed by myeloablative conditioning in this high-risk population resulted in a high treatment related mortality of 40%. Still, outcomes fell into an expected range for high-risk myeloid disease in an elderly and comorbid population. Based on expected outcomes for high-risk patients from the literature (Armand et al, Blood, 2014), decitabine did not markedly improve overall survival outcomes, recognizing that no direct comparisons are available in our limited study population. Decitabine may increase the risk of peri-transplant infections by contributing to a cumulative immunologic insult combined with disease-related immunosuppression and transplant-related toxicity, highlighting the importance of strict vigilance for infections within this setting. Diligent monitoring may improve infectious outcomes as shown in the second half of the cohort; only two out of the latter 10 patients on protocol died of treatment related complications. There were no cases of engraftment failure. Rates of acute and chronic GvHD using a PTCy platform were low and support other studies reporting this benefit. Disclosures No relevant conflicts of interest to declare.

A Prospective Cost Analysis of Non-Myeloablative Hematopoietic Stem Cell Transplantation.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2239-2239
Author(s):  
Chris Skedgel ◽  
Jo-Ann Edwards ◽  
Jean Roy ◽  
Andrea McNeil ◽  
Yvonne Gulliver ◽  
...  
Keyword(s):  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Hospital Admissions ◽  
Chronic Gvhd ◽  
Direct Costs ◽  
First Year ◽  
Hematopoietic Stem ◽  
Post Transplant ◽  
The Cost

Abstract Hematopoietic stem cell transplantation (HSCT) is an intensive medical therapy used to treat both malignant and non-malignant conditions. Non-myeloablative transplantation (NMT) is an emerging transplant modality often performed on an outpatient basis. While NMT is associated with fewer acute complications compared to myeloablative HSCT, long-term complications, particularly chronic graft vs host disease (GvHD), are of concern. To our knowledge, there have been few economic evaluations of NMT and none in a Canadian healthcare environment. We prospectively developed and validated a process for capturing the costs and outcomes of NMT in order to estimate the cost per patient of NMT at a Canadian transplant centre. Ten consecutive patients undergoing NMT were followed from the first day of conditioning (Day −11) until either 1 year post-transplant or death. Donor costs were also recorded. All patient encounters, procedures and interventions during the study period were prospectively recorded. Nursing and other non-physician human resource costs were calculated based on recorded contact times and salaries. Physician costs were derived from Nova Scotia fee codes. Costs of hospital admissions were derived from Ontario Case Costing Initiative (OCCI) data and were specific to the primary diagnosis. Drug costs were based on acquisition costs at hospital and community pharmacies. Materials and equipment costs were based on costs at the QEII Health Sciences Centre, Halifax NS. The proportion of administrative costs to direct costs was derived from OCCI data and applied to local direct costs. All costs are in 2005 Canadian dollars ($CAN). Ten patients were followed for a median of 12 months (range 3.6–12) from September 2003 to April 2005. Eight patients were male and the median age of the cohort was 60 years (19–73). Five patients had AML; 3 had lymphoma and 2 had multiple myeloma.Cyclophosphamide and fludarabine were used as conditioning and tacrolimus and mycophenolate mofetil were used as GvHD prophylaxis. There were 7 hospital admissions among the 10 patients: 3 before day 100 and 4 after day 100. Eight patients survived at least one year post-transplant. No patients developed acute GvHD, while all 8 patients surviving to 1 year post-transplant developed chronic GvHD. Three patients relapsed within 1 year. The average cost per NMT was $CAN 43,377 of which $CAN 31,761 were recipient costs, $CAN 2,562 were donor costs and $CAN 8,675 were equipment and overhead costs. The key cost driver was hospital admissions for complications and/or palliative care at $CAN 9,793 per recipient. Physician fees ($CAN 6,958) and chemotherapy ($CAN 6,485) were also significant. Compared to published estimates of the cost of myeloablative HSCT, NMT appears considerably less costly in the first year post-transplant. Our analysis suggests that the lower cost of NMT was largely attributable to the limited amount of inpatient care these patients received. Further follow-up will be informative since the major complications of NMT including chronic GvHD and relapse may impact per transplant cost after the first year post-transplant. Direct comparison with myeloablative HSCT using our prospective costing method is also planned.

scholarly journals Prophylactic Intervention with N-Acetyl-L-Cysteine before Allotransplant Could Reduce the Occurrence of Poor Hematopoietic Reconstitution after Allogeneic Hematopoietic Stem Cell Transplantation

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2074-2074
Author(s):  
Yuan Kong ◽  
Yu Wang ◽  
Yuan-Yuan Zhang ◽  
Min-Min Shi ◽  
Xiao-Dong Mo ◽  
...  
Keyword(s):  
Risk Factor ◽  
Stem Cell ◽  
High Risk ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Graft Function ◽  
Hematopoietic Stem ◽  
Hematopoietic Reconstitution ◽  
Risk Patients

Abstract Background Poor hematopoietic reconstitution including poor graft function (PGF), characterized by pancytopenia, and prolonged isolated thrombocytopenia (PT), defined as the engraftment of all peripheral blood cells other than platelets, remains a life-threatening complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and the clinical management is challenging. Endothelial cells (ECs) play a crucial role in regulating hematopoiesis in bone marrow (BM) microenvironment. N-acetyl-L-cysteine (NAC), a reactive oxygen species (ROS) scavenger, is clinical used as a mucolytic drug. In this regard, we reported that PGF and PT patients had impaired BM ECs post-HSCT (BBMT 2013; BMT2016;Blood 2016; AJH2018). Recently, we reported in vitro treatment with NAC could improve the defective HSCs through repairing the impaired BM ECs of PGF and PT patients (Blood 2016; AJH2018). However, our previous studies evaluated BM ECs in PGF and PT patients at +3 month(M) post-HSCT. Therefore, whether BM ECs dysfunction in PGF and PT patients is responsible for the defective hematopoiesis, or vice versa, requires to be further clarified. Moreover, prophylactic intervention to improve the impaired BM ECs and HSCs remains unidentified. Aims In order to investigate whether the defective BM ECs pre-HSCT is the risk factor for the occurrence of PGF and PT post-HSCT. Moreover, to evaluate whether prophylactic NAC intervention could repair the impaired BM ECs and reduce the incidence of PGF and PT. Methods Two registered prospective clinical trials were included. The first trial compared the dynamic reconstitution of the BM ECs pre- and post-HSCT among PGF, PT, and good graft function (GGF) patients at Peking University People's Hospital. Multivariate analyses were performed to identify the risk factors for the occurrence of PGF and PT. Receiver operating characteristic (ROC) curves were used to identify the cut-off percentage of BM ECs pre-HSCT to predict high risk patients for PGF and PT. Subsequently, the second trial was performed to investigate whether prophylactic NAC intervention could reduce the incidence of PGF and PT and its underlying mechanism. The quantity and function of BM ECs were evaluated at -14 day (D), 0D pre-HSCT, and +1M, +2M post-HSCT in the patients who were willing to provide BM samples after the written consent. Results In the first trial, 15 patients of the enrolled 68 patients developed PGF or PT, whereas the remaining 53 patients were GGF at +2M post-HSCT. PGF and PT patients demonstrated impaired BM ECs at -14D pre-HSCT and defective dynamic reconstitution at +1M, +2M post-HSCT. Moreover, the BM ECs impairment positively correlated with their ROS levels. Multivariate analysis identified BM EC<0.1% at -14D pre-HSCT was the independent risk factor for the higher incidence of PGF and PT post-HSCT. Based on the ROC cut-off percentage of BM ECs pre-HSCT, the enrolled patients were designated into EC≥0.1% group (N=38) and EC <0.1% group (N=30). Significant higher incidence of PGF and PT was found in EC<0.1% group compared to those in EC ≥0.1% group. The second trial enrolled EC<0.1% patients (N=35) to accept oral NAC (400 mg three times per day) from -14D pre-HSCT to +2M post-HSCT continuously. The remaining EC ≥0.1% patients (N=39) received allo-HSCT only. Prophylactic NAC intervention promoted the dynamic reconstitution of BM ECs and CD34+ cells, whereas reducing their ROS levels, in EC<0.1% group to the similar levels in EC≥0.1% group post-HSCT, which was further confirmed by in situ BM trephine biopsies analyses. No significant difference was observed in the incidence of PGF and PT between the two groups. Importantly, prophylactic NAC intervention significantly reduced the incidence of PGF and PT in EC<0.1% group of the second trial compared with those in EC<0.1% without prophylactic NAC group of the first trial. Summary / Conclusion: BM EC<0.1% at -14D pre-HSCT helps to identify high risk patients for the occurrence of PGF and PT post-HSCT. Prophylactic NAC intervention was safe and effective to prevent the occurrence of PGF and PT in EC<0.1% patients through repairing the impaired BM ECs. Although requiring validation, our data indicate that the impaired BM ECs pre-HSCT is responsible for the occurrence of PGF and PT. Therefore, improvement of BM ECs through prophylactic NAC intervention may represent a promising therapeutic approach to promote hematopoietic recovery post-HSCT. Disclosures No relevant conflicts of interest to declare.

scholarly journals Evaluation of Infectious Complications after Haploidentical Hematopoietic Stem Cell Transplantation with Post-Transplant Cyclophosphamide Following Reduced-Intensity and Myeloablative Conditioning: A Study on Behalf of the Francophone Society of Stem Cell Transplantation and Cellular Therapy (SFGM-TC) Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5758-5758
Author(s):  
Amandine Fayard ◽  
Fabien Tinquaut ◽  
Didier Blaise ◽  
Patrice Chevallier ◽  
Mauricette Michallet ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Infectious Complication ◽  
Ex Vivo ◽  
Infectious Complications ◽  
Bk Virus ◽  
Myeloablative Conditioning ◽  
Hematopoietic Stem ◽  
Post Transplant

Abstract Introduction: Hematopoietic stem cell transplantation (HSCT) is a major treatment for many hematological disorders. However, this treatment comes with significant risks linked to toxicity and infectious complications which may lead to death. Recently haploidentical transplants without ex vivo T-depletion have been developed through the use of post-transplant cyclophosphamide, thus reducing the risk of lethal GVHD. Toxicity data are still limited and few studies have evaluated infectious complications following haploidentical transplants without ex vivo T-cell depletion. In this study, we evaluated the incidence of infectious complications in patients who received haploidentical HSCT with post-transplant cyclophosphamide. Patients and methods: Data from 21 French centers and one Belgian center were retrospectively collected. Between January 2013 and December 2014, 159 patients all older than 18 years, affected with hematological malignancy and having undergone a haploidentical HSCT were included. Informed consent was obtained in accordance with the Declaration of Helsinki. Clinical data were obtained through ProMISe (Project Manager Internet Server), the internet-based system shared by all Francophone transplantation centers. Results: In total, 159 patients were included (Table 1). The median age at transplantation was 51.2 years (20-72 years). All patients were treated with post-transplant cyclophosphamide combined with an anticalcineurin and mycophenolate mofetil as GVHD prophylaxis. The median follow-up of the cohort was 14 months. Meanwhile, 49 patients (13%) developed acute GVHD (grade 2-4). Forty-three patients (27%) developed chronic GVHD. Median overall survival wasn't reached and the median progression-free survival was 571 days. At the end of the study, 69 patients had died, 29 were in relapse and 36 presented treatment related toxicity. TRM was of 14% and 22% at day 100 and 365 respectively. At least one infectious complication occurred in 135 patients. These were mostly clinically or microbiologically documented. Median time from transplant to the first occurrence of infectious complication was 12 days. Twenty five percent of patients presented between 3 and 5 infectious complications. The average number of infectious complications per patient was 2.9 (0-12). Sixty-two percent of early infectious complications occurred throughout conditioning or within 20 days post- transplant. Fifty-two percent of those infections were bacterial, 33% viral (39% of which related to CMV and 28% to BK virus), and 4.5% were parasitic or fungal (50% of which related to aspergillosis). Overall 436 infectious episodes were reported: bloodstream infections (62%) (bacteremia, viremia, fungemia or parasitaemia), respiratory (10%), urinary tract (8%), digestive tract (6%), skin (3%), septic shock and multi organ failure (6%), others (5%). Among those complications, 46% were bacteria related, 36% were virus related (17% of which due to BK virus and 39% to CMV), 7% were parasitic or fungal related (in these cases, 61% aspergillosis related). In total, 26 cases (6%) of BK virus infections were observed. Conclusion: In conclusion, in these preliminary results, except for maybe in the case of BK infections, incidence of infectious disease after haploidentical HSCT seem not to differ to related or unrelated HSCT. Further prospective studies are necessary to confirm these results, especially by evaluating infectious viremia with BK virus after HSCT haploidentical with post-transplant cyclophosphamide following reduced-intensity and myeloablative conditioning for this patient population. Table 1: Patient disease and treatment characteristics Table 1 Table 1. Disclosures Michallet: Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Astellas Pharma: Consultancy, Honoraria; MSD: Consultancy, Honoraria; Genzyme: Consultancy, Honoraria.

scholarly journals Post-Transplantation Cyclophosphamide after Allogeneic Hematopoietic Stem Cell Transplantation: Results of the Prospective Randomized HOVON-96 Trial in Recipients of Matched Related and Unrelated Donors

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1-1 ◽  
Author(s):  
Cornelis N. De Jong ◽  
Ellen Meijer ◽  
Katerina Bakunina ◽  
Erfan Nur ◽  
Marinus van Marwijk Kooij ◽  
...  
Keyword(s):  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Stem Cell Transplantation ◽  
Financial Support ◽  
Acute Gvhd ◽  
Chronic Gvhd ◽  
Skin Involvement ◽  
Hematopoietic Stem ◽  
Free Survival ◽  
Post Transplant

Background Allogeneic hematopoietic stem cell transplantation (alloHSCT) has been established as a powerful treatment modality for patients with hematological malignancies. The graft-versus-leukemia effect, however, is strongly associated with the occurrence of graft-versus-host disease (GVHD) and subsequent transplant-related mortality (TRM). Several strategies are applied in order to prevent GVHD following T-cell replete alloHSCT including conventional immunosuppression (CIS) with post-transplant administration of cyclosporine A (CyA) and mycophenolic acid (MA), or post-transplant cyclophosphamide (PT-Cy) either or not combined with CIS. Studies in haplo- and HLA matched donor transplantation have shown that PT-Cy is well tolerated and associated with low rates of severe GVHD and TRM. However, evidence from randomized clinical trials on the efficacy of PT-Cy as compared to CIS in the setting of HLA matched alloHSCT is scarce. Aims In the present prospective randomized, multicenter, phase III trial we set out to compare a PT-Cy based immunosuppressive regimen with CIS and address the question whether PT-Cy would be associated with improved GVHD-free/relapse-free survival (GRFS). Endpoints included time to acute and chronic GVHD, progression free survival (PFS), GRFS, overall survival (OS), and adverse events. Methods Hematological patients (pts) with a matched related donor or at least an 8 out of 8 matched unrelated donor were included. Pts randomized for the CIS regimen received CyA twice daily until day +120 followed by tapering until day +180 and MA 16 mg/kg twice daily with a maximum dose of 2160 mg a day until day 84 post-transplant. Pts randomized for PT-Cy received 50 mg/kg of cyclophosphamide on day +3 and +4 combined with CyA from day +5 until day +70. Results A total of 160 pts was randomized 1:2 between CIS and PT-Cy, of whom 94% proceeded to transplant (52 versus 99 pts). Median age was 58 years (range: 20-70), 66% were male. Two pts received myeloablative conditioning. The donor type was matched related in 31% and matched unrelated in 69% of pts. Transplants were derived from peripheral blood in 97% of pts and consisted of median 6.14x106/kg CD34+ cells/kg (range: 1.36-19.4) and median 230x106/kg CD3+ T cells (range: 0-519). Baseline patient and transplantation characteristics were equally distributed between the two treatment arms. The cumulative incidence (CI) at six months of grade II-IV acute GVHD was 48% in recipients of CIS versus 32% following PT-Cy (SHR 0.52, 95%CI 0.31-0.87, p=0.014), and grade III-IV 12% versus 6%. In recipients of PT-Cy, acute GVHD was generally limited to stage 1 skin involvement, whereas more severe skin involvement and bowel involvement were observed following CIS. The two-year CI of chronic extensive GVHD was 50% in recipients of CIS versus 19% following PT-Cy (SHR 0.38, 95%CI 0.21-0.67, p=0.001). The three-year estimate of PFS was 60% (44%-73%) and 58% (46%-67%). The three-year CI of progression/relapse was 26% in the CIS arm versus 32% in the PT-Cy arm. The three-year estimate of OS was 69% (53%-80%) and 63% (52%-73%). The one-year estimate (95% confidence interval) of GRFS was 22% (12%-34%) and 45% (35%-55%), respectively. Conclusion Use of high-dose PT-Cy results in a significant reduction in severe acute and chronic GVHD without affecting relapse, thereby resulting in improved GRFS. Hence, a more intensified immunosuppression regimen with PT-Cy might be preferred as GVHD prophylaxis in the setting of RIC alloHSCT. Figure Disclosures Nur: Novartis Pharmaceuticals: Consultancy. Maertens:Cidara: Other: Personal fees and non-financial support; Gilead Sciences: Other: Grants, personal fees and non-financial support; Amplyx: Other: Personal fees and non-financial support; Merck: Other: Personal fees and non-financial support; Pfizer: Other: Grant and personal fees; Astellas Pharma: Other: Personal fees and non-financial support; F2G: Other: Personal fees and non-financial support. Deeren:Alexion, Amgen, Janssen, Roche, Sunesis, Takeda, Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

Haploidentical Stem Cell Transplantation for Children with High-Risk Leukemia In Chile: Report of the First 15 Cases.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4581-4581
Author(s):  
Julia I Palma ◽  
Lucia Salas ◽  
Flavio Carrion ◽  
Cristián Sotomayor ◽  
Paula Catalán ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Chronic Gvhd ◽  
Viral Reactivation ◽  
High Risk Population ◽  
Hematopoietic Stem ◽  
Post Transplant ◽  
Engraftment Failure

Abstract Abstract 4581 The Chilean population is ethnically diverse, and more than 50% of the children referred for hematopoietic stem cell transplantation lack a suitable donor. To expand the donor pool we assessed the feasibility, tolerance, and efficacy of using a parental haploidentical (HI) donor and a reduced-intensity conditioning regimen for patients with high-risk leukemia; this study was preceded by 2 years of technology transfer from St. Jude Children's Research Hospital. Between March 2006 and November 2009 fifteen patients (median age, 9.6 years) received T cell-depleted grafts at Calvo Mackenna Hospital, from peripheral stem cells mobilized with G-CSF from parental donors. N° aphaeresis/patient = one; 6/15 products required a second depletion, final Log of depletion= 3, 11 (5, 05-1, 64). Median cell doses were CD34+: 9.5 × 106 cells/kg (range, 2.13 – 20.0), CD3+: 1.0 ×105cells/kg (0.11 – 1.59), and CD56+: 67, 9 × 106cells/kg (7, 6–131, 8). 14/15 patients engrafted one1ry primary engraftment failure and in 2 cases a 2ry engraftment failure (CMV and Toxoplasmosis treatment). Eight remain alive and clinically well at a median follow up of 12.4 months post-transplant (7.2 – 52.2). Four patients died after bone marrow relapse, while only one died of transplant-related causes. Virus reactivation was the main post-transplant complication: 9/15 had positive CMV PCR but none had CMV disease. One patient developed acute GvHD > grade II and one had chronic GvHD. In this setting, HI transplantation offers a rational option for children who lack suitable stem cell donors. This information is especially relevant for populations that are poorly represented in international donor registries. On the other hand HISCT with RIC with ATG and TNI permits a good OS and EFS in this especially high risk population low TRM. This approach is associated with low incidence of GvHD and high viral reactivation incidence but no lethal infection even without CD3+ lymphocyte recovery due probably to pre-emptive treatment and fast NK cell recovery. Disclosures: No relevant conflicts of interest to declare.

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