Search

Prophylactic donor lymphocyte infusions (DLI) are used to augment post-transplant immune recovery to reduce both infectious complications and disease recurrence. Preclinical studies implicate the naive T-cell subset as the primary driver of graft-versus-host disease (GvHD). In this phase I dose escalation study, we assessed the safety of a DLI that was depleted of CD45RA+ naive T cells. Sixteen adult patients received a prophylactic DLI at a median of 113 days (range 76–280 days) following an HLA-identical, non-myeloablative allogeneic hematopoietic stem cell transplantation. Three patients each received the naive T-cell depleted DLI with a CD3+ dose of 1 × 105/kg, 1 × 106/kg, and 5 × 106/kg. The maximum dose of 1 × 107/kg was expanded to 7 patients. No dose-limiting grade III/IV acute GvHD or adverse events attributable to the DLI were observed at any dose level. One patient developed grade 2 acute GvHD of skin and upper intestines, and another developed moderate chronic GvHD of the lungs following the DLI. With a median follow-up of 2.8 years, 2-year progression-free and overall survival is 50.0% and 68.8%, respectively. In conclusion, these data suggest that a DLI that has been depleted of CD45RA+ naive T cells is feasible and carries a low risk of acute or chronic GvHD.

Patients undergoing allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT) require extensive hospitalizations or daily clinic visits for the duration of their transplantation. Home HCT, wherein patients live at home and providers make daily trips to the patient's residence to perform assessments and deliver any necessary interventions, may enhance patient quality of life and improve outcomes. We conducted the first study of home HCT in the United States to evaluate this model in the US healthcare setting and to determine the effect on clinical outcomes and quality of life. This case-control study evaluated patients who received home HCT at Duke University in Durham, North Carolina, from November 2012 to March 2018. Each home HCT patient was matched with 2 controls from the same institution who had received standard treatment based on age, disease, and type of transplant for outcomes comparison. Clinical outcomes were abstracted from electronic health records, and quality of life was assessed via Functional Assessment of Cancer Therapy-Bone Marrow Transplant. Clinical outcomes were compared with Student's t-test or Fisher's exact test (continuous variables) or chi-square test (categorical variables). Quality of life scores were compared using the Student t-test. All analyses used a significance threshold of 0.05. Twenty-five patients received home HCT, including 8 allos and 17 autos. Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within 1 year of transplantation. Pre-HCT quality of life was well preserved for autologous home HCT patients. This Phase I study demonstrated that home HCT can be successfully implemented in the United States. There was no evidence that home HCT outcomes were inferior to standard-of-care treatment, and patients undergoing autologous home HCT were able to maintain their quality of life. A Phase II randomized trial of home versus standard HCT is currently underway to better compare outcomes and costs.

Prophylactic donor lymphocyte infusions (DLI) are used to augment post-transplant immune recovery to reduce both infectious complications and disease recurrence. Preclinical studies implicate the naive T-cell subset as the primary driver of graft-versus-host disease (GvHD). In this phase I dose escalation study, we assessed the safety of a DLI that was depleted of CD45RA+ naive T cells. Sixteen adult patients received a prophylactic DLI at a median of 113 days (range 76-280 days) following an HLA-identical, non-myeloablative allogeneic hematopoietic stem cell transplantation. Three patients each received the naive T-cell depleted DLI with a CD3+ dose of 1 × 10

PURPOSE: Pain is common for hematopoietic stem cell transplant (HSCT) patients, and may be experienced pre-transplant, acutely post-transplant, and for months or years following transplant. HSCT patients with persistent pain may be at risk for poor quality of life following transplant; however, the impact of pre-transplant pain on quality of life post-transplant is not well understood. Self-efficacy for chronic disease management is associated with quality of life among cancer patients and may impact quality of life for HSCT patients. The primary aim was to examine the effect of pre-transplant pain and self-efficacy on quality of life domains in the year following transplant. METHODS: 166 HSCT patients completed questionnaires providing information on pain, self-efficacy, and quality of life prior to transplant, at discharge, and 3-, 6-, and 12-months post-transplant as part of a longitudinal, observational study. Linear mixed modeling examined the trajectories of these variables and the effect of pre-transplant pain and self-efficacy on post-transplant quality of life. RESULTS: Pain and social and emotional quality of life remained stable in the year following transplant while self-efficacy and physical and functional quality of life improved. Pre-transplant pain was significantly related to lower physical well-being post-transplant. Lower pre-transplant self-efficacy was related to lower quality of life across all domains post-transplant. CONCLUSION: Above and beyond the effect of pre-transplant pain, self-efficacy for managing chronic disease is important in understanding quality of life following transplant. Identifying patients with pain and/or low self-efficacy pre-transplant may allow for early intervention with self-management strategies.

Importance Cutaneous chronic graft-vs-host disease (cGVHD) is common after allogeneic hematopoietic stem cell transplant and is often associated with poor patient outcomes. A reliable and practical method for assessing disease severity and response to therapy among these patients is urgently needed. Objective To evaluate the interrater agreement and reliability of skin-specific and range of motion (ROM) variables of the 2014 National Institutes of Health (NIH) response criteria for cGVHD and a skin sclerosis grading scale (SSG). Design, Setting, and Participants In this observational study performed at a single tertiary academic center, 6 academic blood and marrow transplant specialists and 4 medical dermatologists examined 8 patients with diagnosed cutaneous cGVHD on July 10, 2015. The patient cohort was enriched for patients with sclerotic features. Each patient was evaluated by using the skin-specific and ROM criteria of the 2014 NIH response criteria for cGVHD and an SSG ranging from 0 to 3. Each patient was also asked to complete quality-of-life scoring instruments. Interrater agreement and reliability were estimated by calculating the Krippendorff α and Cohen κ statistics. Data were analyzed from September 29, 2015, through November 22, 2018. Main Outcomes and Measures Estimation of interrater agreement by interclass coefficient (Krippendorff α and Cohen κ statistics) for the skin-specific and ROM components of the 2014 NIH Response Criteria for Chronic GVHD and for the SSG. Results The median age of the patients evaluated was 54 years (range, 46-58 years). Patients were predominantly male (6 [75%]). Six of the 8 patients had a predominantly sclerotic cutaneous phenotype. Interrater agreement among our experts was acceptable for NIH skin feature score (0.68; 95% CI, 0.30-0.86) and good for NIH ROM scoring (0.80; 95% CI, 0.68-0.86). Dermatologists had acceptable agreement for NIH skin GVHD score (0.69; 95% CI, 0.25-0.82) and skin feature score (0.78; 95% CI, 0.17-0.98), good agreement in ROM grading (0.85; 95% CI, 0.69-0.90), and near perfect agreement in identifying sclerosis (0.82; 95% CI, 0.27-0.97). Conclusions and Relevance Although dermatologists had acceptable agreement in NIH skin GVHD score and skin features score, near perfect agreement in identifying cutaneous sclerosis, better agreement in grading severity of cutaneous cGVHD, especially in the intermediate grades, appears to be needed.

Topic Significance & Study Purpose/Background/Rationale Chimeric Antigen Receptor Therapy (CAR T) is a dynamic rapidly developing area of cancer treatment. The delivery of this therapy is complex and many centers struggle with operationalizing the various phases of this treatment, including which specialty area is best equipped to administer, monitor and safely manage the patient for potentially life threatening side effects during each phase of therapy. Without a dedicated CAR T service, it was the determined that adult patients receiving this treatment would be best managed on our intermediate care leukemia/lymphoma unit. Methods, Intervention, & Analysis Prior to treating our first commercial patient, a multidisciplinary team met biweekly to outline a process diagram delineating phases of treatment, team member responsibilities, and SOPs for monitoring and administration of therapy. The inpatient nursing leadership team quickly recognized the need for education and standardization to adequately prepare staff and create a safe patient environment. After an extensive literature search looking at various CAR T programs throughout the country, the nursing leadership team identified a list of high priority action items to develop before the first patient was treated. Using functionality within the EMR, a directed neurologic assessment tool was developed for CAR T patients, order sets for admission, Cytokine Release Syndrome (CRS), and neurotoxicity were implemented, and a best practice advisory (BPA) was created to ensure team members knew the patient was getting CAR T therapy no matter where they were located within our center. A "one call" process was developed for nursing to verify sufficient doses of tocilizumab were available in advance of administration of CAR T cells, and a very specific after-hours coverage plan was implemented that bypassed the standard hierarchy for notification of abnormal findings and allowed nursing staff to directly the established APP team during the week and the attending physician on call over the weekend and holidays. Findings & Interpretation Between 04/01/2018 and 10/1/2019 there were 17 adult patients treated with a commercial CAR T product. The average length of stay for patients was 15 days. 11 of 17 (65%) of patients developed some degree of CRS and 7 of 17 (41%) of patients developed some degree of neurotoxicity. Only one patient required a transfer to our neuro ICU. Despite having limited experience with assessment and monitoring of these complex side effects, nurses on the intermediate care unit report a high degree of satisfaction with delivering care to CAR T patients. Discussion & Implications With adequate preparation and an engaged multidisciplinary team, CAR T therapy can safely be administered on a non-BMT intermediate care unit. Efforts to streamline and standardize nursing assessment and documentation are essential and help create an environment founded in safety for nurses and patients alike.

Introduction Prophylactic, donor lymphocyte infusion (DLI) is used to augment immune recovery and graft vs. tumor effect following a T-cell depleted alloSCT. However, it carries the risk of inducing severe GvHD. Our pre-clinical murine studies have implicated the naive T-cell, defined by CD62L marker, as the primary driver of alloreactivity. We hypothesize that transferring selected memory T-cells without naive-T cells would endow the patient with cells that do not cause GvHD while augmenting host defense against infection and tumor recurrence. Objectives The goal of the study was to determine the maximum tolerated dose of a prophylactic, delayed DLI that has been depleted of naive T-cells. Methods We enrolled 16 adult patients, median age 54 who met following criteria; a. underwent an alemtuzumab or thymoglobulin-containing non-myeloablative allogeneic transplant from an HLA-identical family donor or an 8/8 HLA-matched unrelated donor (MUD), b. at least 60 days from day of transplantation, c. no active acute GvHD grade II or higher. Primary diseases were CLL; n=1, MM; n=2, MF; n=1, NHL; n=5, MDS; n=1, AML; n=6. A dedicated, non-mobilized donor apheresis procedure was performed following enrollment. Naive, CD45RA+ T-cells were depleted from the collection under an IND using the Miltenyi clinimacs system. A standard phase I, 3+3 dose escalation schema was employed. The dose-limiting toxicity of the DLI was defined as development of grade III/IV acute GvHD within 90 days of the DLI. Results The DLI was infused on median 112.5 days (76 to 280 days) following transplant. 8 patients received matched sibling grafts and 8 received MUD grafts. 3 patients each received naive T-cell depleted CD3+ dose of 1 × 105/kg, 1 × 106/kg, and 5 × 106/kg. The top dose of 1 × 107/kg was expanded to 7 patients. No dose limiting toxicity or adverse event attributable to the DLI was observed at any dose level. 1 patient developed grade 2 acute GvHD and 1 developed moderate chronic GvHD attributable to the DLI. 4 patients had relapsed disease; 2 in the lowest dose and 2 in the highest dose levels. With a median follow-up of 2.75 years, 2-year relapse free and overall survivals are 56.25% and 68.75%, respectively (Fig 1 and 2). NK cells, CD3+T lymphocytes, CD4+ T lymphocytes and CD8+ T lymphocytes show positive correlations of 0.24, 0.40, 0.42 and 0.38 respectively with time following the DLI (Fig 3). Conclusion A prophylactic, naive T-cell depleted DLI can be provided safely, without significant risk of acute GvHD at a dose of 1 × 10e7 CD3/kg. Larger studies in a more homogeneous patient population will be needed to confirm the impact on immune recovery and relapse prevention.

INTRODUCTION: Gastrointestinal (GI) complications including graft versus host disease (GVHD) are a major cause of morbidity and mortality in allogenic stem transplant recipients. While several studies have previously looked into the acute gastrointestinal complications, fewer smaller studies have reported late complications. In this large study, we focus on the late (100 days post-transplant) gastrointestinal complications in allogenic stem transplant recipients METHODS: This is a single center, retrospective study, of all of the adult allogenic stem cell transplant recipients who had their transplant at Duke University over a six year period. A total of 479 patients underwent allogenic stem cell transplant, of whom 392 recipients survived for at least 100 days post-transplant. Late gastrointestinal symptoms were noted in 71 patients, prompting endoscopic evaluation. The primary end point of our study was the diagnosis of GI-GVHD based on endoscopic findings, while overall survival and non-relapse mortality were the secondary end points. RESULTS: Of the 71 patients who underwent endoscopy, 45 (63%) patients had GI-GVHD. Of these 45 patients, 39 (87%) had late acute GVHD, 1 (2%) had chronic GVHD, and 5 (11%) patients had overlap disease. Of the patients who did not have GVHD, the symptoms were mostly related to infectious and inflammatory causes. Less common causes included drug toxicity, food intolerance, disease relapse, and motility issues. In a multivariate analysis, the factors that were most indicative of GI-GVHD were histological findings of apoptosis on the tissue specimen (OR=2.35, 95% CI=1.18 – 4.70, p=0.015) and clinical findings of diarrhea (OR=5.43, 95% CI =1.25 – 23.54, p=0.024). The median survival time from the first endoscopy was 8.5 months. The incidence of non-relapse mortality at 6 months was 31% in patients with GI-GVHD and 19% in patients without GI-GVHD (p=0.42). All the patients with GI-GVHD were on steroid therapy and 31% of them received total parental nutrition. CONCLUSIONS: In our population, close to one-fifth of allogenic transplant recipients experienced late GI complications, warranting endoscopic evaluation. Most of these patients were found to have GI-GVHD which had a high incidence of non-relapse mortality at 6 months and close to one-third of these patients needed total parental nutrition.

BACKGROUND Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). OBJECTIVE This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. METHODS Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. RESULTS Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants’ experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P CONCLUSIONS Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain. CLINICALTRIAL ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ)

Our group previously showed that B cells signal aberrantly through the B cell receptor (BCR) in allogeneic hematopoietic stem cell transplant (HCT) patients with active chronic graft-versus-host disease (cGVHD). Preclinical mouse studies have demonstrated the importance of the proximal BCR molecule, spleen tyrosine kinase (SYK), in cGVHD development. Hypothesizing that the oral small molecule SYK inhibitor, fostamatinib, would safely target aberrant BCR-activated B cells in HCT patients, we are conducting a single-center, investigator-initiated phase 1 trial (NCT02611063). Our primary objective is to evaluate the safety and tolerability of fostamatinib in patients early after HCT and in those with refractory active cGVHD. Secondary objectives include assessment of cGVHD manifestations, B cell activation, and immune recovery. Methods: All patients receive HCT treatment per program standards at Duke University. Prophylaxis (P-cGVHD) subjects enroll 80-150 days after HCT and have no evidence of cGVHD. P-cGVHD subjects receive drug for up to 1 year post-transplant (215-285 fostamatinib days). Steroid-refractory cGVHD (SR-cGVHD) subjects enroll with active cGVHD that persists despite systemic high-dose steroids. SR-cGVHD subjects receive drug for up to 365 days total. For all enrollees, modified continual reassessment criteria are used to determine starting dose (100mg daily, 150mg daily, or 100mg twice BID) and any needed dose modifications. We monitor for drug-limiting toxicities (DLTs), adverse events (AEs), and cGVHD manifestations using NIH cGVHD consensus criteria at up to 12 follow-up visits. Results: 15 of a planned 18 total patients have enrolled. In the P-cGVHD group (n=5), of the 4 patients who completed treatment (mean 239 fostamatinib days), 1 patient developed cGVHD while enrolled and 2 patients subsequently developed cGVHD, 4 and 6 weeks after study completion. The fifth P-cGVHD subject discontinued therapy on study day 155 (provider decision to initiate donor lymphocyte infusion for low CD3+ chimerism). In the SR-cGVHD group (n=10), 2 patients completed treatment (mean 365 fostamatinib days); 3 patients withdrew (mean 132 fostamatinib days), for non-cardiac chest pain, progression of cGVHD, and moved away; and 5 patients are actively enrolled (mean 207 fostamatinib days). Both SR-cGVHD patients who completed the study clinically improved while on fostamatinib and requested continuation of drug. A total of 2, 9, and 4 patients have been initiated on 100mg daily, 150mg daily, and 100mg BID, respectively. At the 100mg daily dose, no DLTs were noted. At the 150mg daily dose, 1 patient developed liver function test (LFT) elevation. At the 100mg BID dose, 2 patients developed LFT elevation and 1 patient developed non-cardiac chest pain. One patient required dose adjustment: 100mg BID to 150mg daily, for LFT elevation. Two serious AEs possibly related to fostamatinib occurred: 1 patient developed non-cardiac chest pain and 1 patient developed a deep venous thrombosis. No probably- or definitely-related serious AEs occurred. To assess whether fostamatinib effectively targets aberrantly activated B cells, we examined subjects' whole blood using flow cytometry. When comparing CD19+ B cells on study day 1 versus study day 60 in the SR-cGVHD group (n=7), we found the relative proportion of CD19+CD38+IgDlow plasmablast-like cells was decreased (p=0.03, Fig 1A-B), suggesting fostamatinib 'hit target.' Importantly, in the P-cGVHD group, total lymphocyte and B cell counts did not decrease during day 1 to day 225 (Fig 1C-D), suggesting fostamatinib did not affect immune recovery when given early after HCT. Further investigations with functional assays are underway. Conclusions: This study demonstrates for the first time that fostamatinib is safe and tolerated in HCT recipients both early after transplant and in those with active cGVHD. Importantly, fostamatinib does not appear to hinder lymphocyte or B cell recovery when initiated between days 80-150 after HCT. Additionally, fostamatinib may effectively target aberrantly activated B cells in patients with active SR-cGVHD. Fostamatinib, now FDA-approved for treatment of immune thrombocytopenia, merits a phase 2, randomized controlled trial to assess efficacy as a prophylactic agent against cGVHD. This work was supported by a National Institutes of Health grant, NIH (NHLBI) R01 HL 129061. Fostamatinib was supplied by Rigel. Disclosures Horwitz: Abbvie Inc: Membership on an entity's Board of Directors or advisory committees. Gasparetto:BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Sung:Novartis: Research Funding; Merck: Research Funding; Seres: Research Funding. 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.

Introduction: Patients receiving autologous (auto) and allogeneic (allo) hematopoietic stem cell transplantation (HCT) typically undergo extensive inpatient hospitalizations, daily "day hospital" visits, or a combination of the two. This aspect of transplant poses a variety of challenges, ranging from nosocomial infections to hospital-induced delirium to lifestyle adjustments. By keeping patients at home, we may lower complications and improve quality of life, as well as potentially lower costs and resource utilization. Methods: We conducted a phase 1 study of home HCT to investigate the safety and feasibility of implementing this strategy in the United States. Patients interested in participating needed to live within a 30 minute drive of a transplant center and underwent a home inspection to assess suitability and safety (e.g. absence of black mold). Eligible patients would still receive pre-transplant conditioning at the hospital or day hospital, but they would be discharged home after receiving their stem cell infusion. The goal was to keep trial participants at home for the duration of transplant. In the morning, nurse practitioners or physician assistants made daily house calls to conduct assessments, examine patients, and draw blood for laboratory studies. These studies were run at the hospital, and in the afternoon a nurse returned to the patient's home to provide home blood transfusions, home intravenous fluids, electrolytes, or antibiotics, or other interventions. If an acute event occurred that could not be safely managed at home (e.g. first evaluation of febrile neutropenia), patients returned to the hospital or day hospital for further workup and care. Likewise, patients returned to the hospital or day hospital for certain routine procedures, such as intravenous methotrexate given as part of graft-versus-host disease prophylaxis or first blood transfusion to ensure there were no reactions. Transplant outcomes were monitored by the medical team throughout the patient's care and confirmed by a clinical research nurse or specialist by chart review. Stool samples, to assess changes in the gut microbiome, were collected at baseline and weekly for the first four weeks, at day 60, 100, and day 180. Samples will undergo 16s rRNA sequencing to identify the taxonomic groups of bacteria present in the gut. Results: Twenty-two patients received home HCT (Table 1). This included 6 allos and 16 autos. Ages ranged from 34-63 years for allos and 46-74 years for autos. In both groups, 2/3 or more of patients had a baseline Karnofsky Performance Status of 70 or 80. Patients in the allo group spent 72% of their days entirely at home, while patients in the auto group spent 52% of their days at home. The main reason for returning to the hospital or day hospital were febrile neutropenia (4 allos and 9 autos). Aside from CMV reactivation (3 of 6 allos, 50%), only 2 allos (33%) and 2 autos (13%) developed bloodstream infections. Three allos developed GVHD; interestingly, these were the three patients that spent the most time in the hospital/day hospital even prior to Day 30 (median 23 days vs. 11 days), even prior to development of GVHD. There was one case of treatment-related mortality (GVHD) in the entire cohort. Overall, patients and their caregivers endorsed the program, providing numerous expressions of appreciation and gratitude on exit interviews, and quality of life was well-preserved as assessed by FACT-BMT: median scores for autos stayed the same when comparing baseline (median 113) to day 30 (median 114) and increased on day 100 (median 124). Discussion: Our results suggest that home HCT is safe and feasible. Despite including mostly older adults with suboptimal performance status, patients did quite well at home. They were able to maintain their quality of life and had low rates of infectious complications. Though patients did have to return to the hospital or day hospital at various times during transplant, keeping patients out of the hospital for even half the duration of transplant could have tremendous cost savings that would offset the increased staffing and travel required for house calls. Studies of the gut microbiome are pending to test the hypothesis that home HCT will preserve the gut microbiome, thereby preventing GVHD. In addition, a randomized phase 2 study of home vs. standard transplant for allogeneic HCT is currently in progress. Disclosures Sung: Novartis: Research Funding; Merck: Research Funding; Cellective: Research Funding. Gasparetto: Janssen, BMS, Celgene: Consultancy; Janssen, BMS, Celgene: Other: Travel, accommodations, or other expenses paid or reimbursed; Celgene: Research Funding; Janssen, BMS, Celgene, Takeda: Honoraria. Rizzieri: Shire: Research Funding; Erytech: Research Funding.