Abstract: Background: Aurora kinases play essential roles in regulating cell division, and increased expression has been noted in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). We previously conducted a phase I study of alisertib combined with "7+3" induction chemotherapy in untreated patients with AML, and found the combination to have an adverse event profile similar to 7+3 alone, with promising efficacy, particularly for patients with high-risk disease, such as those who were older, with high-risk molecular features, or with secondary AML. These patients collectively have a historically grim prognosis, with an approximate rate of remission, in trials, of 45%. CPX-351, a liposomal daunorubicin-cytarabine product, was recently approved for use in secondary AML after it was demonstrated to be superior to 7+3 induction, with a median survival of 9.6 months versus 5.9 months among older patients, in a phase 3 trial. We recently completed accrual to a phase II study of alisertib plus induction chemotherapy in patients with untreated, high-risk AML. Methods: Patients were eligible if they had AML defined by WHO 2016 and either an adverse-risk karyotype (European Leukemia Net Guidelines), secondary (post-MDS/MPN) AML, therapy-related AML, or age ≥ 65 vears. We used a Simon two-stage design, assuming a null composite remission rate (complete remission [CR] and CR with incomplete count recovery [CRi] ) of 45%. Patients could be enrolled prior to cytogenetic classification, but those without adverse-risk karyotype who lacked other eligibility criteria were removed before day 8 and replaced. All patients received continuous infusion cytarabine 100mg/m2 on days 1-7 [D1-7] and idarubicin 12mg/m2 [or daunorubicin 60mg/m2] D1-3 (7+3). On D8 through D15, alisertib at 30mg BID orally (PO) was administered. All underwent a mid-induction marrow biopsy to assess for residual disease, which if present, was treated with 5+2 re-induction without alisertib. Following remission, patients could receive up to 4 consolidation cycles with cytarabine (3g/m2 BID D1,3,5 for age 〈 60 and 2g/m2 daily D1-5 for age ≥60) with alisertib PO at 30mg BID, D6-12, and alisertib maintenance at 30mg BID PO (D1-7 of 3 week cycles) thereafter for 12 months. Patients who pursued stem cell transplant (SCT) were followed for EFS and OS. Results: 39 eligible patients were enrolled. The median age was 67 (range 33-83); 25 (64%) were male, and 33 (85%) were Caucasian. 22 patients (56%) had secondary AML (16 with antecedent MDS, 2 with antecedent CMML, 1 with antecedent MPN, and 3 with therapy-related AML). 13 (33%) exhibited adverse risk karyotype. FLT3 mutations were seen in 7 (18%), NPM1 in 7 (18%), IDH1 in 5 (13%), IDH2 in 5 (13%), CEBPA in 3 (8%), and TP53 mutations in 4 (10%) patients. 33 patients (85%) demonstrated an ablated marrow at mid-treatment, and six (15%) received re-induction at mid-treatment. 8 patients (21%) were refractory to induction, and five (13%) died prior to response assessment due to infection or bleeding. The 30-day and 60-day mortality rates were 8% and 13%, respectively. Patients experienced expected grade 4 toxicities of leukopenia, anemia, thrombocytopenia, and febrile neutropenia; no new attributable safety signals were detected. The CR+CRi rate was 64% (2-stage 95% CI 48-79%) with 20 patients (51%) achieving CR and 5 (13%) achieving Cri. The CR+CRi rate was 59% (13 of 22) in those with secondary AML, 67% (18 of 27) in those aged ≥ 65, 77% (10 of 13) in those with adverse risk karyotype, and 75% (3 of 4 patients) in patients with TP53 mutations. One (3%) patient achieved a partial remission. Based on the composite remission rate of 64%, the combination was deemed effective per study design. 5 patients have relapsed to date. 10 have received at least 1 cycle of consolidation, 16 patients (41%) have gone on to SCT. With a median follow-up of 14 months (Figure), the 12-month overall survival (OS) is 51% (37-65%). Although the data continues to mature, median OS is 12.2 months (90% CI 8.8-NA). In the subset of patients achieving a CR+CRi, the 12-month relapse-free survival was 52% (90% CI 34-67%). Conclusions: Alisertib, a novel aurora A kinase inhibitor, combined with conventional induction, is efficacious and demonstrates a promising rate of remission and survival among patients with previously untreated high-risk AML. Larger randomized studies are under consideration to better assess the promise of this novel combination. Figure. Figure. Disclosures Brunner: Takeda: Research Funding; Novartis: Research Funding; Celgene: Consultancy, Research Funding. DeAngelo:Glycomimetics: Research Funding; ARIAD: Consultancy, Research Funding; BMS: Consultancy; Novartis Pharmaceuticals Corporation: Consultancy, Honoraria; Shire: Honoraria; BMS: Consultancy; Amgen: Consultancy; Pfizer Inc: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Glycomimetics: Research Funding; ARIAD: Consultancy, Research Funding; Amgen: Consultancy; Takeda: Honoraria; Blueprint Medicines: Honoraria, Research Funding. Amrein:Takeda: Research Funding. Steensma:Acceleron: Consultancy; Amphivena: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; H3 Biosciences: Research Funding; Janssen: Consultancy, Research Funding; Kura: Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees; Onconova: Consultancy; Otsuka: Membership on an entity's Board of Directors or advisory committees; Syros: Research Funding; Takeda: Consultancy. Garcia:Celgene: Consultancy. Rosenblatt:Bristol-Myers Squibb: Research Funding; Celgene: Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Merck: Membership on an entity's Board of Directors or advisory committees. Chen:Magenta Therapeutics: Consultancy; REGiMMUNE: Consultancy; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda Pharmaceuticals: Consultancy. Fathi:Astellas: Honoraria; Seattle Genetics: Consultancy, Honoraria; Boston Biomedical: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Agios: Honoraria, Research Funding; Jazz: Honoraria.

Abstract: The role of haploidentical hematopoietic cell transplantation (HCT) using posttransplant cyclophosphamide (PTCy) for acute lymphoblastic leukemia (ALL) is being defined. We performed a retrospective, multivariable analysis comparing outcomes of HCT approaches by donor for adults with ALL in remission. The primary objective was to compare overall survival (OS) among haploidentical HCTs using PTCy and HLA-matched sibling donor (MSD), 8/8 HLA-matched unrelated donor (MUD), 7 /8 HLA-MUD, or umbilical cord blood (UCB) HCT. Comparing haploidentical HCT to MSD HCT, we found that OS, leukemia-free survival (LFS), nonrelapse mortality (NRM), relapse, and acute graft-versus-host disease (aGVHD) were not different but chronic GVHD (cGVHD) was higher in MSD HCT. Compared with MUD HCT, OS, LFS, and relapse were not different, but MUD HCT had increased NRM (hazard ratio [HR], 1.42; P = .02), grade 3 to 4 aGVHD (HR, 1.59; P = .005), and cGVHD. Compared with 7/8 UD HCT, LFS and relapse were not different, but 7/8 UD HCT had worse OS (HR, 1.38; P = .01) and increased NRM (HR, 2.13; P ≤ .001), grade 3 to 4 aGVHD (HR, 1.86; P = .003), and cGVHD (HR, 1.72; P ≤ .001). Compared with UCB HCT, late OS, late LFS, relapse, and cGVHD were not different but UCB HCT had worse early OS (≤18 months; HR, 1.93; P & lt; .001), worse early LFS (HR, 1.40; P = .007) and increased incidences of NRM (HR, 2.08; P & lt; .001) and grade 3 to 4 aGVHD (HR, 1.97; P & lt; .001). Haploidentical HCT using PTCy showed no difference in survival but less GVHD compared with traditional MSD and MUD HCT and is the preferred alternative donor HCT option for adults with ALL in complete remission.

Abstract: Introduction: Geriatric assessment (GA) is a multidimensional evaluation of patient health and function that may detect impairments not identified as part of routine care, predict treatment-related morbidity and mortality, and inform treatment plans. Given evidence of these benefits, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend GA for older candidates of hematopoietic stem cell transplantation (HCT). However, both older and younger HCT candidates will often receive multiple rounds of chemotherapy before HCT, leading to functional impairments in all age groups. Furthermore, HCT patients often experience a significant gap between when they are first evaluated and actually proceed to transplant (e.g., while a donor search is conducted), creating an opportunity to identify impairments and optimize function prior to transplant. Methods: To address this opportunity, we created a clinical pre-HCT optimization program (C-POP) to evaluate physical function, cognitive function, nutritional status, and mental health in all adults who were deemed potential candidates for allogeneic HCT by a HCT physician. We applied this standard of care program to all adult candidates for HCT, regardless of age, with the goal of identifying functional impairments and then referring patients to services to optimize those impairments prior to HCT. We defined impairments using validated measures and compared results to established norms or scoring, controlling for age and gender where appropriate (e.g., the cut-off for six-minute walk distance was adjusted for age, gender, height, and weight, while the cut-off for falls was any fall regardless of characteristics). Patients with impairments were referred to the appropriate supportive care (e.g., physical function impairment - 〉 referral to physical therapy). Results were prospectively analyzed at new patient evaluation (NPE), which was the first time the patient met a HCT physician and sign-off, which occurred within a week before starting transplant. While the program is ongoing, we present here the results of patients evaluated between October 16th, 2017 and July 1st, 2019. Patients are divided into three pre-specified age groups: 〈 40 years old, 40-59 years old, and 〉 =60 years old, with results compared using a chi-squared test. Results: We evaluated 115 patients: 21 (18%) 〈 40 years, 40 (35%) 40-59 years, and 54 (47%) 〉 =60 years). There were no differences between the age groups in other demographics (gender, race, and ethnicity). At NPE, 93 (81%) met criteria for at least 1 impairment in physical function, cognitive function, nutritional status, or mental health; 62 (54%) met criteria for impairments in 2 or more areas. Surprisingly, patients 〈 40 years were more likely to screen positive for physical function (20/21, 95%) than patients 40-59 years (26/40, 65%) and patients 〉 =60 years (36/54, 67%) (p=0.03). Of those 115 patients, 52 (45%) proceeded to HCT, including 12 (57%) 〈 40 years, 18 (45%) 40-59 years, and 22 (41%) 〉 =60 years (p=0.75); of those patients who have not proceeded to HCT, 40 (35%) will never proceed to HCT (e.g., deemed not a candidate after functional evaluation or died of disease prior to HCT) while 23 (20%) are still awaiting HCT (e.g., donor search ongoing). Patients who proceeded to HCT were less likely to have mental health impairments (2/52, 4% vs. 9/40, 23%, p=0.006). Of the 52 who were seen at new patient evaluation and proceeded to transplant, 40 (77%) were seen at sign off. Of those who had impairments at NPE, 12/23 (52%) improved their physical function to normal limits, 4/9 (44%) improved their cognitive function, and 9/13 (69%) improved their nutritional status by the time of sign-off (of those who were seen at sign-off, none had mental health impairments at NPE). Discussion: These results demonstrate that younger as well as older candidates for HCT exhibit a high degree of functional impairment. However, this impairment could be amenable to improvement prior to HCT. These findings support application of GA to all HCT candidates regardless of age. We will investigate the effect of referred interventions (e.g., physical therapy, seeing a dietician) in improving functional impairments in future studies, as well as look at the effect of these findings on HCT outcomes. Disclosures Wiggins: Incyte, Inc.: Speakers Bureau. Gasparetto:Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Rizzieri:Millennium: Speakers Bureau; Novartis: Consultancy; AbbVie: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; Incyte: Consultancy, Speakers Bureau; TEVA: Consultancy; Spectrum: Consultancy; Kite Pharma: Consultancy; Gilead Sciences: Consultancy, Speakers Bureau; Seattle Genetics: Consultancy, Speakers Bureau; Jazz Pharmaceuticals: Speakers Bureau. Horwitz:Abbvie Inc: Membership on an entity's Board of Directors or advisory committees. Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding.

Abstract: Abstract 4058 Stratification models for prediction of the likelihood of success of peripheral blood stem cell collection via apheresis in patients are lacking. Peripheral blood (PB) CD34+ cells concentration ([CD34+]) pre-apheresis, and blood volume processed (BVP) have been shown to predict the CD34+ cell dose collected on the first day of apheresis (Pierelli et al Vox Sanguinis 2006, 91; 126). We sought to determine the predictive value of these factors, in addition to other mobilization and patient characteristics, in a total 851 consecutive autologous apheresis procedures performed at M.D. Anderson Cancer Center between 01/05–12/09. Patients and Methods: Baseline patient characteristics considered include age, gender, weight, diagnosis, complete blood counts on day of collection, and the absolute PB CD34+ counts within 24 hours of the first apheresis procedure. The study population was randomly divided into equal study (n=425) and validation (n=426) samples. Results: We report results of analyses performed on the study sample which included 241 Multiple Myeloma patients (pts), 135 Non-Hodgkin's Lymphoma pts, and 49 Hodgkin's pts. Logistic regression analysis was used to evaluate the association between CD34+ collected dose 〉 2 × 106/Kg (available for 401/425 pts) and BVP (L); BVP/Kg; pre-apheresis blood counts including [CD34+], Hemoglobin level (≤10 vs. 〉 10 g/dL), WBC ( 〈 4 vs. 〉 4 x109/L), absolute neutrophil count [ANC] ( 〈 vs.≥ median), and platelet count (≤150 vs. 〈 150 x109/L); days to first apheresis procedure from start of mobilization regimen ( 〈 vs. ≥ median); patient's age (quartiles) and gender; and diagnosis. On univariate analysis, pre-apheresis [CD34+] count was the most significant predictor of CD34+ dose collected on the first day of apheresis (graph). Ninety-six percent of patients with [CD34+] 〉 40/μL (n=158) collected 〉 2 x106CD34+ cells/Kg, while only 8% of those with [CD34+] ≤ 10/μL (n=25) reached that target. The proportion of patients who collected 〉 2 x106CD34+ cells/Kg increased from 15% to 67% with increasing [CD34+] counts ranging between11–40/μL (n=218). Additional significant predictors of higher CD34+ dose collected in this group of pts (n=218) included larger BVP/Kg ( 〉 0.2 L/Kg, n=50, p 〈 0.001), shorter than the median duration from start of mobilization to the first apheresis procedure (n=122, p 〈 0.001), and male gender (n=128, p 0.01). Low Hemoglobin (n=42, p 0.007), low WBC (n=69, p 0.02), low platelet count (n=41, p 0.02), age 〉 60 yrs (n=90, p0.06), and NHL histology (n=56, p 0.02) were associated with collection of lower CD34+yield/Kg. There was no impact of patient's weight or ANC. Multivariate analyses are ongoing to evaluate the independent prognostic value of these predictors. The resulting model will be validated in an independent sample. Conclusion: Patients whose pre-apheresis absolute CD34+ counts are between 11–40/μL may be able to collect a higher CD34+ cell dose/Kg on the first day of stem cell collection if higher blood volume is processed, especially patients who took longer to mobilize.Table:ABS PRE APHERESIS CD34 between 11–40/μL (N=218)N 〉 2 X106/Kg CD34 D1OR95% CIP valueFinal pre-apheresis CD34+ count/μL    11–155915%Ref.    16–258831%2.41.06–5.70.04    25–302952%5.92.1–160.001    31–404267%114.3–29 〈 0.001BVP, L, Day 1 quartiles    146333%Ref.     〉 14–165240%1.30.6–2.90.4     〉 16–185437%1.20.5–2.50.7     〉 184736%1.10.5–2.50.8BVP, L/Kg, Day 1, quartiles    ≤ 0.216631Ref     〉 0.250562.91.5–7.70.001*Days on GCSF 〈 med    Yes8716%5.52.8–10.8 〈 0.001    No11951%Combination days on G-CSF/BV    Fewer days G-CSF/High BVP3266%Ref.    Fewer days G-CSF/Low BVP8746%0.40.2–1.030.06    More days on G-CSF/High BVP1533%0.30.1–0.90.04    More days on G-CSF/Low BVP7113%0.10.03–0.2 〈 0.001Age, years    ≤ 6012841%Ref.     〉 609029%0.60.3–1.020.06Labs Before starting mobilizationHgb g/dL, quartiles    ≤104221%0.40.2–0.80.007     〉 1017339%Ref.WBC x109/L, quartiles     〈 46919%0.20.05–0.70.02    ≥ 414644%Ref.PLT x109/L, quartiles    ≤1504119%0.40.2–0.80.02     〉 15017440%RefWBC Day 1 apheresis    ≤median10424%0.30.2–0.6 〈 0.001     〉 median11447%Diagnosis    Non-Hodgkin's lymphoma5623%0.40.2–0.90.02    Hodgkin's1937%0.80.3–2.20.7    Multiple Myeloma14341%Ref.Gender    Female9027%0.50.3–0.90.01    Male12843%Ref. Disclosures: No relevant conflicts of interest to declare.

Abstract: Abstract 4047 Stem Cell collection via apheresis is the preferred method of collecting stem cells for hematopoietic stem cell transplantation. Accurate prediction of stem cell yield is important for the planning of apheresis procedures and for the collection of adequate stem cells. Pierelli et. al. (Vox Sanguinis 2006, 91; 126) proposed a mathematical formula to estimate the CD34+ dose collected on 1st day of apheresis based on the peripheral blood (PB) CD34+ concentration pre-apheresis and the blood volume processed (BVP). Patients and Methods : We tested the predictive value of this formula in a multicenter sample of 1608 apheresis procedures performed at 5 centers (SCSP n=85, CAS n=195, HIAE n=305, China n=172, MDACC n=851). A 50% randomly selected sample of the MDACC study population was included in this analysis. Each contributing institution selected all consecutive apheresis procedures performed over a designated time frame. Baseline patient characteristics were collected including age, gender, diagnosis, mobilization regimen, complete blood counts on day of collection, and the absolute PB CD34+ counts within 24 hours of the first apheresis procedure. Subjects who did not have data on the PB CD34+ counts were not included in the analysis. Information on total BVP and CD34+ cells collected/kg was also collected. There were 694 males (59%), median age was 50 years. To facilitate comparison of results, we used the same statistical methods reported by Pierelli et. al. to assess the correlation between the actual (ay) and predicted (py) CD34+ yields, including assessment of the linear correlation between these measures and the distribution of the ay/py ratio. Results: Data on both actual and predicted yields were available for 1148 (97%) records. Overall, Pearson's correlation coefficient (r) between ay and py was 0.67, ranging from 0.67 for MDACC to 0.86 for China and CAS. Median ay/py ratio was 1.1 (0.02–433) ranging from 0.99 for HIAE to 1.5 for China and CAS. To characterize the correlation between ay and py and facilitate the clinical application of our findings, we classified the actual and predicted yields as falling below ( 〈 2), within (2–5), or above ( 〉 5) the conventionally acceptable collected CD34+ doses (x106/Kg). Positive predictive value (PPV) of py was estimated considering the distribution of ay as the “gold standard”. PPV was relatively high for py 〉 5 [85% (95% CI 81–89%)], average for py 〈 2 [72% (95% CI 68–76%)], and low for py between 2 and 5 [56% (95% CI 51–62%)] . This pattern was consistent across institutions. PPV ranged from 55% (SCSP) to 80% (China) for py 〈 2; from 37% (CAS) to 68% (MDACC) for py between 2 and 5, and from 73% to 94% for py 〉 5, exceeding 80% at all institutions except SCSP. Overall, 13% of cases predicted to have a CD34+ yield between 2 and 5, had an actual yield 〈 2. This proportion varied across institutions ranging from 5% at SCSP to 28% at HIAE. Notably, the distribution of BVP (ml/Kg) was comparable across the 3 categories of ay defined above with a median of 204 (range 74–263). Consistent pattern was also observed within institutions. Conclusion: Our data indicate that the formula of Pierelli et.al. is associated with high PPV for predicted CD34+ doses 〉 5, acceptable PPV for doses 〈 2, and relatively low PPV for doses falling between 2 and 5. The data also suggests that CD34+ yields correlate with pre-apheresis CD34+ count and are independent of BVPNTotal 1182rangeSCSP 85rangeCAS 195rangeChina 172rangeHIAE 305rangeMDACC 425rangeAbsolute PB CD34+ × 106/μl (median, range)280.3–2735314.2–279251.3–1750140.3–411310.6–604312–2735Weight, Kg (median, range)729–1696738–143619–1106322–1007313–1438411–169Day 1 Blood volume processed, L (median, range)153–131148–25123–299.54.5–12.5195–131168–27Actual Day 1 CD34+ dose (x 106/Kg), (median, range)2.90.01–1092.90.2–293.80.01–1091.80.01–503.50.1–442.80.2–101 〈 236%27%33%53%34%33%2–531%40%28%20%27%39% 〉 533%33%38%27%39%28%Predicted Day 1 CD34+ dose (× 106/Kg), (median, range)2.40.02–2112.60.3–242.20.1–730.960.02–253.20.1–672.40.1–211 〈 244%45%44%63%33%42%2–530%25%37%17%28%35% 〉 527%30%19%20%38%23%Ratio CD34+ dose collected/predicted1.10.02–4331.10.2–111.50.03–6.31.50.02–4330.990.04–121.10.1–9.9Pearson's correlation coefficient0.670.830.860.860.770.67Pearson's within Predicted Day 1 dose 〈 20.420.080.630.50.570.282–50.280.250.280.20.360.25 〉 50.560.770.810.70.630.6 Disclosures: No relevant conflicts of interest to declare.

Abstract: Patients diagnosed with acute myeloid leukemia (AML) face sudden-onset life-threatening disease that requires intensive treatments. Although their early disease trajectory is characterized by significant, toxic side effects, limited data are available describing coping strategies among patients with AML and how these inform patient-reported outcomes. We used cross-sectional secondary data analyses to describe coping in 160 patients with newly diagnosed high-risk AML. The Brief COPE, Hospital Anxiety and Depression Scale, Post-Traumatic Stress Disorder Checklist–Civilian Version, and Functional Assessment of Cancer Therapy–Leukemia were used at time of AML diagnosis to measure coping strategies, psychological distress, and quality of life (QOL), respectively. The median split method for distribution of coping domains and multivariate regression models were used to assess the relationship between coping and patient-reported outcomes. Participants (median age, 64.4 years) were mostly non-Hispanic White (86.3%), male (60.0%), and married (73.8%). Most (51.9%) had high utilization of approach-oriented coping strategies, whereas 38.8% had high utilization of avoidant coping strategies. At time of diagnosis, use of approach-oriented coping was associated with less psychological distress (anxiety, β = –0.262, P = .002; depression symptoms, β = –0.311, P & lt; .001; and posttraumatic distress disorder symptoms, β = –0.596, P = .006) and better QOL (β = 1.491, P = .003). Use of avoidant coping was associated with more psychological distress (anxiety, β = 0.884, P & lt; .001; depression symptoms, β = 0.697, P & lt; .001; and posttraumatic distress disorder symptoms, β = 3.048, P & lt; .001) and worse QOL (β = –5.696, P & lt; .001). Patients with high-risk AML use various approach-oriented and avoidant coping strategies at time of diagnosis. Use of approach-oriented coping strategies was associated with less psychological distress and better QOL, suggesting a possible target for supportive oncology interventions.

Abstract: Introduction: While hematopoietic stem cell transplantation (HSCT) has great therapeutic potential, intensive conditioning regimens and variability in time to stem cell engraftment result in a period of pancytopenia and immunosuppression in which patients are vulnerable to infection. Bloodstream infections (BSIs) occur in 20-45% of inpatient autologous and allogeneic transplant patients, leading to prolonged hospitalization and increased mortality. One method of infection prevention is daily application of the antiseptic chlorhexidine gluconate (CHG). Daily CHG bathing, either with a CHG wash or with application of CHG-impregnated cloths, has been shown to reduce the incidence of all-cause hospital-acquired BSIs in critically ill patients, such as those in the ICU, though very few studies include HSCT patients. Methods: We conducted an observational cohort study to assess the impact of daily CHG bathing on the rate of BSIs among adults undergoing inpatient HSCT at the Duke University Medical Center. Patients were included if they were admitted for pre-transplant conditioning and inpatient monitoring for allogeneic or autologous HSCT from January 2016 through December 2018. CHG bathing was instituted in January 2017 for all patients admitted to the inpatient HSCT unit using 2% CHG-impregnated cloths (SAGE™), providing one year of data with no CHG bathing and two years of data with bathing. Patients were tracked from admission until unit discharge, transfer, or first infection. Laboratory-confirmed bloodstream infections (LCBI), central-line associated bloodstream infections (CLABSI), and mucosal barrier injury laboratory-confirmed bloodstream infections (MBI-LCBI) were determined per CDC/NHSN definitions. An additional variable of "clinically-significant infection" was recorded; this included both laboratory-confirmed BSIs and infections deemed significant by the treatment team but that did not meet CDC/NHSN criteria. For example, patients that were febrile, hypotensive, and treated with antibiotics, but with only one positive culture of a common commensal were deemed to have a clinically-significant BSI. Because not all patients adhered to CHG, patients were grouped into four categories by rate of daily CHG usage: High ( 〉 75%), Medium (50-75%), Low (1-49%), and None (0%). Baseline characteristics and clinical outcomes between groups were compared via ANOVA, Chi-squared test, or Cochran-Armitage two-sided trend test. Multivariate analysis using the Fine-Grey subdistribution hazard model was conducted to compare time to all infection variables, accounting for the effects of CHG usage, antibiotic prophylaxis regimen, and type of transplant. Results: We evaluated 192 patients hospitalized for HSCT, including 118 (62%) allogeneic transplants and 74 (38%) autologous transplants. Of these, 25 (13%) had high CHG usage, 33 (17%) medium, 45 (23%) low, and 89 (46%) none. Demographics and transplant characteristics were evenly matched between the CHG usage groups with the exception that high usage groups were more likely to receive levofloxacin for antibiotic prophylaxis (p=0.003). Increased CHG usage was significantly associated with decreased incidence of clinically-significant infection (p=0.006), CLABSI (p=0.04), and MBI-LCBI (p=0.002) (Table 1). Multivariate analysis did not demonstrate a significant contribution of antibiotic prophylaxis regimen. No significant difference was found between CHG usage groups in median days to stem cell engraftment, incidence of febrile neutropenia or C. difficile infection, or rashes requiring medical treatment. There were no rashes attributable to CHG usage. Among patients who were VRE rectal swab negative on admission, there was a significant trend toward lower rates of VRE acquisition with increasing CHG usage (High CHG 13.6% vs No CHG 25.3%, p=0.02). Discussion: Increased CHG usage is associated with a significant trend toward lower rates of clinically-significant infection, CLABSI, MBI-LCBI, and VRE colonization in adult inpatients undergoing HSCT. Effects are most strongly seen at 〉 75% daily CHG usage. There were no adverse effects due to CHG application. The significant decrease in MBI-LCBI with topical CHG suggests an interaction between the skin microbial environment and enteric organisms. Therefore, further research exploring the effects of CHG on the skin and gut microbiota is warranted. Disclosures Gasparetto: BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Horwitz:Abbvie Inc: Membership on an entity's Board of Directors or advisory committees. Rizzieri:Celgene, Gilead, Seattle Genetics, Stemline: Other: Speaker; AbbVie, Agios, AROG, Bayer, Celgene, Gilead, Jazz, Novartis, Pfizer, Sanofi, Seattle Genetics, Stemline, Teva: Other: Advisory Board; AROG, Bayer, Celgene, Celltron, Mustang, Pfizer, Seattle Genetics, Stemline: Consultancy; Stemline: Research Funding. Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding.

Abstract: Abstract 4387 Absolute peripheral blood (PB) pre-apheresis CD34+ count has been shown to predict the CD34+ yield/Kg in patients undergoing autologous stem cell mobilization and apheresis. Determining correlates of PB pre-apheresis CD34+ counts would facilitate identifying patients that may be at high risk of mobilization failure. Methods. A total of 851 consecutive autologous apheresis procedures were performed at M.D. Anderson Cancer Center between January 2005 and December 2009. We randomly selected half (N=413) of this study population to serve as a study sample (described in table), and preserved the remaining for validation studies. In this study population, we observed that 96% of patients with PB pre-apheresis CD34+ counts of 〉 40/μL collected 〉 2×106 CD34+cells/Kg on the first day of apheresis. We sought to determine patient and disease characteristics that are associated with higher PB pre-apheresis CD34+ counts ( 〉 40/μL). These factors included patient age (quartiles), gender, weight (quartiles), diagnosis (Multiple Myeloma vs. Hodgkin's and Non-Hodgkin's Lymphoma), disease status at transplant (remission vs. active disease), number of prior chemotherapy regimens ( 〈 2 vs. ≥2), blood count on day of collection: hemoglobin level (≤10 vs. 〉 10 g/dL), WBC ( 〈 4 vs. ≥ 4 ×109/L), absolute neutrophil count [ANC] ( 〈 vs.≥ median), and platelet count (≤150 vs. 〈 150 ×109/L); and number days (≤ vs. 〉 median) from the beginning of mobilization to the first apheresis procedure. Results. On univariate analysis, shorter duration from beginning of mobilization therapy to first day of apheresis (odds ratio [OR] =4.7, p 〈 0.001), and weight 〉 95 Kg (OR=1.8, p=0.01), were significantly associated with a PB CD34+count 〉 40/μL; whereas a diagnosis of Multiple Myeloma (OR=0.5, p=0.002), age 〉 60 years (OR=0.6, p=0.009), pre-apheresis WBC 〈 4 × 109/L (OR=0.5, p=0.004) and ANC ( 〈 median p=0.003) were significantly associated with PB CD34+ counts of ≤ 40/μL. These factors, with the exception of age, remained significant on multivariate analysis. Shorter duration of mobilization (OR=8.1, p 〈 0.001) had the strongest association with PB CD34+ count 〉 40/μL. A diagnosis of Multiple Myeloma was associated with lower PB CD34+ count in patients who had a shorter mobilization course (OR=0.3, p 〈 0.001), but not in those who took longer to mobilize. Lower WBC and ANC counts were associated with lower PB CD34+ count, and this effect was more pronounced for patients who had both low WBC and ANC (OR=0.4, p=0.001) than for those who had low ANC but high WBC count (OR=0.5, p=0.025). Weight 〉 95 Kg was still associated with higher PB CD34+ count, (OR=1.9, p 0.01). There was no association between PB CD34+ count and any of the remaining factors evaluated. Conclusion: Our data suggest that patients who take longer to mobilize, have low WBC and [ANC] pre-apheresis might benefit from early intervention with novel mobilization strategies. Totals may vary because of missing data. Disclosures: Popat: Otsuka: Research Funding.

Abstract: Introduction: Allogeneic hematopoietic stem cell transplantation (allo-HCT) provides a potential cure for a multitude of diseases but can result in high rates of morbidity and mortality. These outcomes have been associated with donor choice, with umbilical cord blood (UCB) perceived as an inferior option to matched related or matched unrelated donors (MRD/MUD) due to increased morbidity and mortality the first year after allo-HCT due to delayed engraftment and increased graft versus host disease (GvHD). At the same time, studies have shown that recipients of cells from younger donors do better, and UCB is the youngest donor cell source available. Given that UCB may have long-term benefits, we evaluated long-term survival in recipients of UCB vs. MRD/MUD in patients who had survived at least 1 year. Methods: This is a retrospective analysis of ≥1 year (≥365 days) survivors of first allo-HCT from the Duke Adult Bone Marrow Transplant (ABMT) program over a twenty year period from January 1, 1996 to December 31, 2015. Detailed clinical data was extracted from the Duke ABMT database and electronic medical record. Patients who either died or were lost to follow-up within 1 year of transplant were excluded. Also excluded were those who received an allo-HCT for a disease other than a hematologic malignancy and those who received haploidentical or mismatched adult cells, as these donor sources have been associated with worse outcomes and the goal was to compare UCB to MRD/MUD. Patient characteristics included gender, race, ethnicity, transplant diagnosis, transplant year, hematopoietic cell transplantation-specific comorbidity index (HCT-CI), Karnofsky performance score (KPS) at transplant workup, age at transplant, donor cell characteristics, conditioning regimen, acute GvHD (aGvHD), date of relapse, and date of death. Chi-square tests or Fisher's exact tests were used to compare categorical variables, as appropriate, and Wilcoxon Rank Sum tests or t-tests were used to compare continuous variables, as appropriate. A Kaplan-Meier estimator was used to analyze overall survival. A Cox Proportional Hazard model with stepwise selection with significance of entry=0.1 and significance of stay=0.2 was used to evaluate the patient characteristics of age, gender, race, disease, KPS, conditioning type, history of aGvHD, and decade of transplant and adjusted for selected covariates to compare the two groups. Results: Over the 20-year study period, 848 patients received a first allo-HCT, of whom 456 (54%) survived at least 1 year post-HCT: 102 (22%) UCB and 354 (78%) MRD/MUD. UCB recipients were more likely to be younger (median 42 years vs. 50 years, p= 〈 0.001), African American (25% vs 6%, p 〈 0.001), and have acute leukemia (70% vs. 49%, p=0.001). There were no differences in conditioning regimen (myeloablative conditioning 61% vs. 51%, p=0.08), pre-HCT performance status (KPS 80-100 87% vs. 82%, p=0.08), or comorbidities (HCT-CI ≤3 61% vs. 74%, p=0.052). With regard to post-HCT outcomes, UCB recipients had a higher rate of any aGvHD (70% and 59%, p= 〈 0.001). Conditional on ≥1 year survival of allo-HCT, UCB recipients had a better unadjusted overall survival than adult cell recipients (Figure 1, log rank p=0.03). After adjusting for selected covariates (age, gender, conditioning type, decade of transplant), the hazard rate of UCB recipients was 37% lower than that of MRD/MUD recipients after the 1 year threshold, though this was no longer statistically significant (p=0.09). Discussion: Among patients who survived at least 1 year post-HCT, those who received UCB had a significantly lower risk of mortality on univariate analysis than those who received adult cells. Though this finding was no longer statistically significant on multivariate analysis, there was a strong trend and the lack of statistical significance could be an effect of the small sample size. Additional research across larger populations (e.g. CIBMTR) is warranted to further explore the clinical characteristics and long-term health outcomes between the two groups, especially given the potential for newer UCB approaches such as ex-vivo expansion to decrease the early post-HCT morbidity and mortality associated with UCB and delayed engraftment. If other studies support improved long-term outcomes with UCB, those findings coupled with advances in UCB transplants may promote UCB as a donor source. Disclosures Gasparetto: Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Rizzieri:Celgene, Gilead, Seattle Genetics, Stemline: Other: Speaker; AbbVie, Agios, AROG, Bayer, Celgene, Gilead, Jazz, Novartis, Pfizer, Sanofi, Seattle Genetics, Stemline, Teva: Other: Advisory Board; AROG, Bayer, Celgene, Celltron, Mustang, Pfizer, Seattle Genetics, Stemline: Consultancy; Stemline: Research Funding. Horwitz:Abbvie Inc: Membership on an entity's Board of Directors or advisory committees. Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding.

Abstract: Background: Aggressive non-Hodgkin lymphoma (NHL) commonly affects older adults and is often treated with intensive therapies. Receipt of intensive therapies and absence of a clear transition between the curative and palliative phases of treatment yield prognostic uncertainty and risk for poor end-of-life (EOL) outcomes. However, data regarding the EOL outcomes of this population are lacking. Methods: We conducted a retrospective analysis of adults & gt;65 years with aggressive NHL treated with systemic therapy at Massachusetts General Hospital from 4/2000-7/2020 who subsequently died. We abstracted patient and clinical characteristics and EOL outcomes from the electronic health record (EHR), including patients' place of death, cause of death, palliative care and hospice utilization, and hospice length of stay using the EHR and the Social Security Death Index. We also determined whether patients were hospitalized (yes versus no), received systemic therapy (yes versus no), or were admitted to the ICU (yes versus no) within 30 days of death. Using multivariable logistic regression, we examined factors associated with hospitalization within 30 days of death and hospice utilization. Results: Among 91 patients (median age = 75 years; 37.4% female), the most common lymphoma diagnosis was de novo DLBCL/grade 3B follicular lymphoma (64/91, 70.3%), and the majority (64/91, 70.3%) had advanced stage disease. Overall, 70.3% (64/91) were hospitalized, 34.1% (31/91) received systemic therapy, and 23.3% (21/90) had an intensive care unit admission within 30 days of death. The rates of palliative care consultation and hospice utilization were 47.7% (42/88) and 39.8% (35/88), respectively. A minority (21/88, 23.9%,) received palliative care more than 30 days before death. Of those receiving palliative care consultations, the majority (33/42, 78.6%) occurred exclusively in the inpatient setting, and most (32/42, 76.2%) were seen either as a one-time consultation or followed during a single inpatient hospitalization. Symptom management (24/42, 57.1%) was the most common reason for palliative care consultation, followed by both symptom management and goals of care (11/42, 26.2%) and goals of care (4/42, 9.5%). Only 39.8% (35/88) received hospice services, with 80.7% (71/88) having a hospice length of stay ≤ 7 days. Among hospice enrollees, the median length of stay on hospice was 7 days (range: 0-117). Among all patients, 51.6% (47/91) died in hospital, rehab, or nursing home, 23.1% (21/91) died at home, 11.0% (10/91) died in inpatient hospice or a hospice house, and 14.3% (13/91) had an unknown or other place of death. The most common cause of death was cancer progression (44/91, 48.4%,) followed by infection or cancer treatment complication (20/91, 22.0%). In multivariable analysis, elevated LDH was associated with risk of hospitalization within 30 days of death (OR 3.61, p=0.014). Palliative care consultation (OR 4.45, p=0.005) and hypoalbuminemia (OR 0.29, p=0.026) were associated with likelihood of hospice utilization. Conclusions: Older adults with aggressive NHL often experience high health care utilization and infrequently utilize hospice care at the EOL. Our findings underscore the need for interventions to optimize the quality of EOL care for this population, and provide important data to guide informed decision-making and help inform future interventions aimed at improving the EOL care of this unique geriatric oncology population. Disclosures No relevant conflicts of interest to declare.