Efficacy and safety of outpatient fludarabine, cyclophosphamide, and rituximab based allogeneic hematopoietic cell transplantation in adults with severe aplastic anemia.

The age effect in severe aplastic anemia (SAA) following allogeneic hematopoietic cell transplantation (HCT) favors the use of reduced intensity conditioning (RIC) regimens in older adults. We implemented a non-myeloablative regimen consisting of fludarabine, cyclophosphamide, and rituximab (FCR) to improve HCT outcomes in SAA. Patients who underwent first HCT for SAA utilizing an FCR regimen between January 2016 and May 2022 were included. Outcomes analyzed included time to engraftment, incidence of graft failure, GVHD, viral reactivation, disease recurrence, and GVHD-free, relapse-free survival (GRFS). Among 24 patients included, median age was 43.5 years (22-62) and a variety of donor types and stem cell sources were represented. At median follow-up of 26.9 months (2.4-72.7), no cases of grade III-IV acute (aGVHD) or severe chronic GVHD (cGVHD) were recorded. Viral reactivation was minimal, and there were no cases of graft failure or PTLD, with 100% disease-free and overall survival at last follow up. The estimate of 1-year GRFS was 86.3% (95% CI: 72.8-100%), with moderate cGVHD accounting for all events. The FCR regimen in SAA was well tolerated, even in older adults, with 100% disease-free survival with low GVHD and infection rates. These encouraging findings should be validated in larger prospective trials.

Outpatient CAR T-Cell Therapy as Standard of Care: Current Perspectives and Considerations.

Chimeric antigen receptor T-cell therapy (CAR-T) has altered the treatment landscape of several hematologic malignancies. Until recently, most CAR-T infusions have been administered in the inpatient setting, due to their toxicity profile. However, the advent of new product constructs, as well as improved detection and management of adverse effects, have greatly increased the safety in administering these therapies. CAR-T indications continue to expand, and inpatient administration is associated with increased healthcare resource utilization and overall cost. Therefore, transitioning CAR-T administration to the outpatient setting has been of great interest in an effort to improve access, reduce financial burden, and improve patient satisfaction. Establishment of a successful outpatient CAR-T requires several components, including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Additionally, clear criteria for outpatient administration eligibility and for inpatient admission with pathways for prompt toxicity evaluation and admission, and toxicity management guidelines should be implemented. Education about CAR-T therapy and its associated toxicities is imperative for all clinical staff, as well as patients and their caregivers. Finally, rigorous financial planning and close collaboration with payers to ensure equitable access, while effectively managing cost, are essential to program success and sustainability. This review provides a summary of currently published experiences, as well as expert opinion regarding implementation of an outpatient CAR-T program.

Prevention and management of acute toxicities from conditioning regimens during hematopoietic stem cell transplantation.

Hematopoietic stem cell transplantation (HSCT) remains the only curative option for several hematological malignancies. Its use has continued to grow, with an estimated 23,500 transplants performed annually in the United States alone. The acute toxicities that occur from conditioning chemotherapy can impact the peri-transplant period and have substantial implications on patients' tolerability and outcomes, irrespective of the treatment of their disease. Chemotherapy-induced nausea vomiting (CINV), mucositis, transplant-associated thrombotic microangiopathy (TA-TMA), and sinusoidal obstruction syndrome, also known as a veno-occlusive disease (SOS/VOD) can all have significant implications for patients. These acute complications begin with the start of conditioning chemotherapy and add to potential toxicity for patients throughout the early post-transplant period, from Day +30 for CINV, mucositis, and SOS, and which can continue through at least Day +100 with the onset of TA-TMA. These toxicities must be prevented and managed appropriately. This review will summarize the literature surrounding them and guide their management.

An international learning collaborative phase 2 trial for haploidentical bone marrow transplant in sickle cell disease.

ABSTRACT: In the setting of a learning collaborative, we conducted an international multicenter phase 2 clinical trial testing the hypothesis that nonmyeloablative-related haploidentical bone marrow transplant (BMT) with thiotepa and posttransplant cyclophosphamide (PTCy) will result in 2-year event-free survival (no graft failure or death) of at least 80%. A total of 70 participants were evaluable based on the conditioning protocol. Graft failure occurred in 8 of 70 (11.4%) and only in participants aged <18 years; all had autologous reconstitution. After a median follow-up of 2.4 years, the 2-year Kaplan-Meier-based probability of event-free survival was 82.6%. The 2-year overall survival was 94.1%, with no difference between children and adult participants. After excluding participants with graft failure (n = 8), participants with engraftment had median whole blood donor chimerism values at days +180 and +365 after transplant of 100% (n = 58), respectively, and 96.6% (57/59) were off immunosuppression 1 year after transplant. The 1-year grade 3 to 4 acute graft-versus-host disease (GVHD) rate was 10%, and the 2-year moderate-severe chronic GVHD rate was 10%. Five participants (7.1%) died from infectious complications. We demonstrate that nonmyeloablative haploidentical BMT with thiotepa and PTCy is a readily available curative therapy for most adults, even those with organ damage, compared to the more expensive myeloablative gene therapy and gene editing. Additional strategies are required for children to decrease graft failure rates. The trial was registered at www.clinicaltrials.gov as #NCT01850108.

Impact of initiating oral anticancer agents for leukemia on adherence to medications for multiple chronic conditions.

INTRODUCTION: Increased use of oral anticancer agents (OAAs) has empowered adults with chronic lymphocytic leukemia (CLL) and chronic myelogenous leukemia (CML) to manage their therapy, but this shift may complicate medication use, particularly among adults with multiple chronic conditions (MCC). METHODS: This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with CML or CLL. To be included, patients must have been at least 18 years old, diagnosed with and had 2+ claims for an OAA indicated for either CML or CLL, continuously enrolled 12 months before and after OAA initiation, and treated for (2+ fills) at least two select chronic conditions. Proportion of days covered (PDC) determined medication adherence and was compared for 12 months before and after OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. RESULTS: Among CLL patients, mean OAA adherence in the first year of therapy was 79.8% (SD: 21.1) and 74.7% (SD: 24.9) for commercial and Medicare patients, respectively; mean adherence for CML patients was 84.5% (SD: 15.8) and 80.1% (SD: 20.1) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (PDC ≥ 80%) to comorbid therapies was generally unchanged following OAA initiation. Consistently unremarkable changes in MCC adherence were observed in 12-month difference-in-differences models, but significant decline was observed in MCC adherence after 6 months of OAA use. CONCLUSIONS: OAA initiation among adults with CML or CLL was not associated with significant, initial changes to adherence to medications for chronic diseases.

Chimeric Antigen Receptor T-Cell Therapy in the Outpatient Setting: An Expert Panel Opinion from the American Society for Transplantation and Cellular Therapy.

The first series of chimeric antigen receptor T (CAR-T) cell therapy products were approved in 2017 to 2019 and have shown remarkable efficacy in both clinical trials and the real-world setting, but at the cost of prolonged patient hospitalization. As the toxicity management protocols were refined, the concept of cellular therapy administered in the outpatient setting gained steam, and single institutions began to perform certain aspects of CAR-T monitoring in the outpatient setting for select patients. However, there are many considerations for a successful outpatient program. In anticipation of increasing use of CAR-T-cell therapy in the outpatient setting as a mechanism to overcome frequent hospital bed shortages and high cost of inpatient care, the American Society for Transplantation and Cellular Therapy convened a group of experts in hematology, oncology, and cellular therapy to provide a comprehensive review of the existing publications on outpatient CAR-T cell therapy, discuss selected ongoing clinical trials of outpatient CAR-T, and describe strategies to optimize safety without compromising efficacy for patients treated and monitored in the outpatient setting.

Real-world analysis of tumor lysis syndrome in patients started on venetoclax combination for acute myeloid leukemia.

INTRODUCTION: Venetoclax is utilized with low-dose cytarabine or a hypomethylating agent for the treatment of acute myeloid leukemia. Clinical trials report a risk of tumor lysis syndrome and the package insert recommends a venetoclax dose ramp-up at the initiation. The purpose of this study was to evaluate the risk of tumor lysis syndrome in a large population of patients with acute myeloid leukemia outside of a clinical trial and evaluate the incidence of hospital-acquired complications during inpatient ramp-up. METHODS: We performed a retrospective study of adult patients with acute myeloid leukemia receiving venetoclax with a hypomethylating agent or low-dose cytarabine. The primary outcome was the incidence of tumor lysis syndrome. Secondary outcomes included risk factors for tumor lysis syndrome, length of admission, and incidence of hospital-acquired complications. RESULTS: One hundred thirteen patients were included. Although all patients were given some form of prophylaxis, the incidence of tumor lysis syndrome was 8.8%. All were laboratory tumor lysis syndrome; one with hyperuricemia, nine with hypocalcemia, and ten with hyperphosphatemia. Six patients received sevelamer. Tumor lysis syndrome was resolved in all cases. No clinical tumor lysis syndrome occurred. Hepatic dysfunction, tumor lysis syndrome high-risk stratification, higher baseline white blood cell count, and lactate dehydrogenase levels were more common in the tumor lysis syndrome group. Hospital-acquired complications reached 13% in those directly admitted for dose ramp-up. CONCLUSIONS: Tumor lysis syndrome was uncommon and manifested as minor lab abnormalities. White blood cell count continues to be an indicator of risk for tumor lysis syndrome. Those who present with an elevated white blood cell or are otherwise at high risk for tumor lysis syndrome should be admitted for ramp-up. Otherwise, initiation and monitoring of venetoclax are feasible in the outpatient setting.

Evaluation of healthcare-associated infection rates in patients with hematologic malignancies and stem cell transplantation during the coronavirus disease 2019 (COVID-19) pandemic.

Objective: To evaluate whether rates of healthcare-associated infections (HAIs) changed during the coronavirus disease 2019 (COVID-19) pandemic in malignant hematology and stem cell transplant patients. Design: A retrospective, cohort study. Patients: The study included malignant hematology and stem cell transplant patients admitted between March 1, 2019, through July 31, 2019, and March 1, 2020, through July 31, 2020. Methods: Rates of catheter-associated urinary tract infections (CAUTIs), central-line-associated bloodstream infections (CLABSIs), central-line-associated mucosal barrier injury infections (CLAMBIs), and Clostridioides difficile infections (CDIs) during the pandemic were compared to those in a control cohort. Secondary outcomes included the rate of non-COVID-19 respiratory viruses. Results: The rate of CAUTIs per 1,000 hospital days was 0.435 before the pandemic and 0.532 during the pandemic (incidence rate ratio [IRR], 1.224; 95% confidence interval [CI], 0.0314-47.72; P = .899). The rate of CLABSIs was 0.435 before the pandemic and 1.064 during the pandemic (IRR, 2.447; 95% CI, 0.186-72.18; P = .516). The rate of CLAMBIs was 2.61 before the pandemic and 1.064 during the pandemic (IRR 0.408, 95% CI 0.057-1.927; P = .284). The rate of CDIs was 2.61 before the pandemic and 1.579 during the pandemic (IRR, 0.612; 95% CI, 0.125-2.457; P = .512). Non-COVID-19 respiratory virus cases decreased significantly from 12 (30.8%) to 2 cases (8.3%) (P = 0.014). Conclusions: There was no significant difference in HAIs among inpatient malignant hematology and stem cell transplant patients during the COVID-19 pandemic compared to those of a control cohort. Rates of infection were low among both cohorts. Rates of community-acquired respiratory viruses decreased significantly during the pandemic among this population.

Antiemetic Strategies in Patients Who Undergo Hematopoietic Stem Cell Transplantation.

Hematopoietic stem cell transplantation (HSCT) is an integral part of the treatment strategy in patients with a hematological disorder. Chemotherapy-induced nausea and vomiting (CINV) is still an issue in patients who undergo HSCT. While several guidelines for the antiemetic therapy against CINV have been published, there is no detailed information about appropriate antiemetic drugs for each conditioning regimen in HSCT. Various studies reported that the triplet of 5-HT3RA, NK1RA, and dexamethasone appears useful in HSCT. However, each antiemetic has unique adverse effects or interactions with specific drugs. Here, we review the literature relating to clinical trials on the prevention of CINV, and summarize the information to clarify the benefit of antiemetic regimens.

Implementation of a model integrating primary and oncology pharmacists' care for patients taking oral anticancer agents (OAA).

Improvements in chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) treatment options have increased the 5-year survival rates for patients with these hematologic malignancies. In addition to cancer management, these patients may need help to manage multiple chronic conditions (MCC). The overall objective of this study is to examine the impact and implementation of a model that coordinates care between oncology and primary care pharmacists for people taking an oral anti-cancer agent (OAAs) and medications for comorbid chronic conditions. This is a multi-center, prospective, single-arm pilot study that will recruit up to 40 patients from Michigan Medicine and Vanderbilt University Medical Center (VUMC). Eligible participants will be 18 years of age or older, prescribed an OAA, have a diagnosis of either CML, CLL or MM, and be diagnosed with and taking medication for at least two specified chronic conditions. The Pharmacists Coordinated Care Oncology Model (PCOM) is a two-month intervention that builds upon current pharmacist clinical responsibilities. Generally, participants will complete a patient-reported outcome measure at 2 and 6 weeks post-OAA initiation that is sent to their oncology pharmacist, and they will also receive a comprehensive medication review at week 4 from a primary care pharmacist for their chronic medications. The pharmacists will communicate about the results via electronic medical record (EMR) and intervene if necessary. The primary endpoints are (1) dose-adjusted OAA proportion of days covered (PDC), and (2) PDC for chronic condition medications. PDCs will be determined via prescription records. The association of OAA and chronic medication PDCs will be quantified via correlation and chi-squared tests. The association between symptom experience and OAA adherence will be examined via correlation analyses. For implementation, characteristics of patient participants, feasibility, acceptability, adoption, fidelity, and trialability will be described. Data will be collected via EMR and pharmacist and patient interviews. Median/IQR for acceptability, adoption and fidelity will be reported, and patient interviews will be analyzed using a grounded theory approach and pharmacist interviews will be analyzed using thematic analyses.

Chimeric antigen receptor T-cell therapy: Challenges and framework of outpatient administration.

Adoptive cellular therapy has made a landmark change within the treatment paradigm of several hematologic malignancies, and novel cellular therapy products, such as chimeric antigen receptor T-cell therapy (CART), have demonstrated impressive efficacy and produced durable responses. However, the CART treatment process is associated with significant toxicities, healthcare resource utilization, and financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile. Improved toxicity management strategies and a better understanding of cellular therapy processes are now established. Therefore, efforts to transition CART to the outpatient setting are warranted with the potential to translate into enhanced patient quality of life and cost savings. A successful launch of outpatient CART requires several components including a multidisciplinary cellular therapy team and an outpatient center with appropriate clinical space and personnel. Telemedicine should be incorporated for closer monitoring. Additionally, clear criteria for admission upon clinical decompensation, a pathway for prompt inpatient transition, and clear toxicity management guidelines should be implemented. Effective education about cellular therapy and toxicity management is imperative, especially for the Emergency Department and Intensive Care Unit teams. Here, we have outlined the various logistical and clinical considerations required for the care of CART patients, which will aid centers to establish an outpatient CART program.

Medication Adherence Among Adults With Comorbid Chronic Conditions Initiating Oral Anticancer Agent Therapy for Multiple Myeloma.

PURPOSE: Increased use of oral anticancer agents (OAAs) has empowered adults with multiple myeloma (MM) to manage their oncolytic therapy, but such a shift may result in issues with medication use, particularly among patients being concurrently treated for pre-existing, multiple chronic conditions. METHODS: This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with MM. To be included, adults (18 years and older) must have been diagnosed with and had 2+ claims for an OAA, had continuous enrollment for 12 months before and after OAA initiation, and have been previously diagnosed with and had prescription fills for 2+ select chronic conditions. The proportion of days covered metric assessed medication adherence and was compared for 12 months before and after the OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. RESULTS: The mean OAA adherence in the first year of therapy was 58.3% (standard deviation: 24.5) and 65.1% (standard deviation: 27.01) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (proportion of days covered ≥ 80%) to comorbid therapies generally declined in the first year after OAA initiation. Changes in medication use were particularly noticeable among those on antihypertensive therapy: adjusted analyses uncovered a 2.5% (Medicare) and 5.2% (commercial) difference in adherence to these medications between those initially adherent and nonadherent to OAA therapy (both P < .05). CONCLUSION: Initiating OAA therapy in adults with MM may complicate an already complex treatment regimen, resulting in poor overall medication adherence in patients with multiple comorbid conditions.

Reduction in the Prevalence of Thrombotic Events in Sickle Cell Disease after Allogeneic Hematopoietic Transplantation.

Thrombosis is a recognized complication in sickle cell disease (SCD). Allogeneic hematopoietic cell transplantation (allo-HCT) remains the sole curative option for patients with severe SCD phenotypes. Data describing the effects of allo-HCT on recurrent thrombotic events (venous and arterial events) are limited, however. We evaluated 31 patients with SCD who underwent allo-HCT with a median follow-up of 34.5 months (range, 13 to 115) post-transplantation. No patient continued anticoagulation or antiplatelet therapy after allo-HCT. There was an absolute difference of 32% (95% confidence interval [CI], 12.3% to 32.2%; P = .002) in the prevalence of venous thromboembolic (VTE) events before and after allo-HSCT. In addition, there was an absolute difference of 38.5% (95% CI, 10.63 to 45.96; P = .006) in the number of ischemic cerebrovascular accidents (CVAs) occurring before and after allo-HSCT. Patients with severe SCD who undergo allo-HCT are less likely to develop recurrent thrombotic events compared with a control cohort of patients matched for age and genotype (odds ratio, 0.22; 95% CI, 0.058 to 0.83; P = .025). Following curative therapy with allo-HCT, there is a reduction in recurrent arterial and venous thrombosis in patients with severe SCD phenotypes.

The use of venetoclax-based salvage therapy for post-hematopoietic cell transplantation relapse of acute myeloid leukemia.

For patients with high risk myeloid disease, allogeneic hematopoietic cell transplantation (HCT) is the only potentially curative therapy. Unfortunately, many of these patients relapse after HCT and have a limited survival. The recent approval of venetoclax, an orally bioavailable BCL-2 inhibitor, resulted in significant responses in treatment naïve acute myeloid leukemia (AML), and off-label use in the relapsed/refractory setting is increasing. We report the outcomes of 21 patients who underwent allogeneic HCT for myeloid disease, relapsed with AML, and were treated with venetoclax. Several patients had poor risk features including antecedent hematologic malignancy (6/21), complex karyotype (6/21), and TP53 mutations (5/21). The median age was 64.5 years and time from HCT to relapse was 5.7 months (range: 0.9 to 44.9 months). Of the 19 patients who were assessed for response, there were meaningful treatment responses seen in eight patients: five CR, three CRi, zero PR, for an ORR of 42.1%. Treatment effect was seen in six additional patients, including four in the morphologic leukemia-free state. Nine patients maintained their response for ≥3 months and eight were receiving therapy at data cut. Post-HCT AML relapse has an exceedingly poor outcome, and venetoclax-based therapy is a potent therapy option that should be studied prospectively in this setting.

Maintenance Strategies After Hematopoietic Cell Transplantation.

Hematopoietic cell transplantation (HCT) is an essential component of potentially curative therapy for patients with hematologic malignancies. High-dose chemotherapy with autologous (auto) stem cell rescue is used to overcome chemoresistance in multiple myeloma, non-Hodgkin lymphoma, and Hodgkin lymphoma. Alternatively, poor-risk acute leukemias rely on the graft versus leukemia effect of allogeneic (allo) products. Long-term remissions are feasible with both auto- and allo-HCT; however, disease relapse is the leading cause of death after HCT for many patients. In recognition of this, novel therapies are being investigated in the upfront, relapsed/refractory, and post-HCT maintenance settings to deepen response and maintain disease control. To date, the most robust data to support this approach are in multiple myeloma, where post-transplant maintenance therapy has improved clinical outcomes. In Hodgkin lymphoma, patients with high-risk features may benefit from post-auto-HCT vedotin (BV) regardless of pre-HCT BV exposure. Apart from mantle cell lymphoma, where rituximab maintenance is generally accepted, post-auto-HCT maintenance in other forms of NHL is less established. In patients who undergo allo-HCT, the utilization of maintenance therapy is an important component of improving post-HCT outcomes, however, an individualized approach that considers patient factors such as residual toxicity from HCT, an immature graft with poor graft function, infection, and graft-versus-host disease create a complex environment for aggressive interventions. Initiation of directed agents in patients with identified mutations prior to allo-HCT, including FLT3 in acute myeloid leukemia and Philadelphia chromosome in acute lymphoid leukemia have generally improved post-HCT outcomes. Ongoing studies are exploring the safety and efficacy of additional maintenance strategies post-allo-HCT in an effort to further improve post-HCT outcomes.

Medication Adherence, Health Care Utilization, and Costs Among Patients Initiating Oral Oncolytics for Multiple Myeloma or Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

BACKGROUND: Oral oncolytic therapies have improved survival in hematologic cancers, such as chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and multiple myeloma (MM), which are now being managed like chronic conditions. However, compared with other cancers, there is a lack of studies assessing adherence, health care resource utilization, and costs in patients with these cancers. OBJECTIVE: To assess factors associated with adherence to oral oncolytic therapies, health care utilization, and costs in patients with CLL/SLL or MM. METHODS: A retrospective database study was conducted using the IBM MarketScan Commercial Claims and Medicare Supplement databases. Adults (aged ≥ 18 years) diagnosed with and prescribed an oral oncolytic for CLL/SLL (ibrutinib or idelalisib) or MM (thalidomide, lenalidomide, or pomalidomide) between 2013 and 2016 and with continuous eligibility 6 months before and 12 months after oral oncolytic initiation were identified. Adherence to oral oncolytics was measured using the proportion of days covered (PDC) metric. Multiple linear regression and multivariable logistic regression were used to identify adherence predictors. Count models assessed the relationship between adherence and resource utilization, and generalized linear models assessed the relationship between adherence and health care costs. RESULTS: A total of 701 and 2,385 patients were identified with CLL/SLL or MM, respectively. Mean PDC (SD) for CLL/SLL and MM patients was 75.3 (22.5) and 57.6 (26.5), respectively. For CLL/SLL patients, those aged ≥ 65 years (beta [B] = -4.00) had lower medication use. Among MM patients, multiple predictors of higher medication use emerged: aged ≥ 65 years (B = 3.44), higher than average outpatient resource utilization (B = 3.53), insurance plan other than preferred provider organization (PPO; B = -2.58), previous cancer therapy (B = -2.81), higher number of concurrent unique therapeutic classes (B = -0.35), and higher comorbidity burden (B = -2.55). Patients with CLL/SLL and enrolled in plans other than a PPO were more likely to be adherent (OR = 1.41, 95% CI = 1.01-1.98), whereas patients who were aged ≥ 65 years, were residents of the southern United States, and had visited the emergency department in the baseline period were less likely to be adherent. For MM patients, those aged ≥ 65 years (OR = 1.68, 95% CI = 1.38-2.04) and with higher than average outpatient services utilization (OR = 1.24, 95% CI = 1.01-1.52) were more likely to be adherent, whereas those enrolled in plans other than a PPO, previously treated with cancer therapy, and with higher comorbidity burden were less likely to be adherent. In both cohorts, adherent patients had significantly lower odds of health care utilization and incurred lower medical costs, but higher prescription costs, following oncolytic initiation; however, total costs were not significantly lower in those adherent. CONCLUSIONS: Factors were identified that influenced adherence at the patient, treatment, and health system levels. These factors can be used to identify patients requiring interventions for improving medication-taking behavior and associated health care burden. DISCLOSURES: This study received no outside funding. Dashputre was recently employed by Novartis; K. Gatwood has received speaker fees from Jazz Pharmaceuticals; and J. Gatwood has received research funding from Merck & Co. and GlaxoSmithKline, unrelated to this study..

New-onset post-transplant diabetes mellitus after haploidentical hematopoietic cell transplant with post-transplant cyclophosphamide.

Haploidentical hematopoietic cell transplant (haplo-HCT) with post-transplant cyclophosphamide (PTCY) is utilized for patients with hematological disorders but without conventional donors. The effects of new-onset post-transplant diabetes mellitus (PTDM) following haplo-HCT are unknown. We examined PTDM incidence and outcomes after haplo-HCT with PTCY. Patients without diabetes receiving haplo-HCT (n=64) were analyzed for PTDM diagnosis (defined as blood glucose≥ 200 mg/dL). By day 100, 14 (22%) patients developed PTDM (median, 18 days). Hyperglycemia (blood glucose ≥ 200 mg/dL) preceded corticosteroids in 11 (79%) individuals. PTDM patients had increased death/relapse (p=0.029). PTDM occurs frequently, precedes corticosteroids, and leads to inferior outcomes following haplo-HCT. PTDM prophylaxis/treatment may improve HCT survival.