Daratumumab in Pediatric Relapsed/Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma: DELPHINUS Study.

Patients with relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) have poor outcomes compared with newly diagnosed, treatment-naïve patients. The phase 2, open-label DELPHINUS study evaluated daratumumab (16 mg/kg intravenously) plus backbone chemotherapy in children with relapsed/refractory B-cell ALL (n=7) after ≥2 relapses and children and young adults with T-cell ALL (children, n=24; young adults, n=5) or LL (n=10) after first relapse. The primary endpoint was complete response (CR) in the B-cell ALL (end of Cycle 2) and T-cell ALL (end of Cycle 1) cohorts, after which patients could proceed off study to allogeneic hematopoietic stem cell transplant (HSCT). Seven patients with advanced B-cell ALL received daratumumab with no CRs achieved; this cohort was closed due to futility. For the childhood T-cell ALL, young adult T-cell ALL, and T-cell LL cohorts, the CR (end of Cycle 1) rates were 41.7%, 60.0%, and 30.0%, respectively; overall response rates (any time point) were 83.3% (CR+CR with incomplete count recovery [CRi]), 80.0% (CR+CRi), and 50.0% (CR+partial response); minimal residual disease-negativity (<0.01%) rates were 45.8%, 20.0%, and 50.0%; observed 24-month event-free survival rates were 36.1%, 20.0%, and 20.0%; observed 24-month overall survival rates were 41.3%, 25.0%, and 20.0%; and allogeneic HSCT rates were 75.0%, 60.0%, and 30.0%. No new safety concerns with daratumumab were observed. In conclusion, daratumumab was safely combined with backbone chemotherapy in children and young adults with T-cell ALL/LL and contributed to successful bridging to HSCT. This trial was registered at www.ClinicalTrials.gov as NCT03384654.

A Prospective Cohort Quality Improvement Study to Reduce the Time to Antibiotics for New Fever in Neutropenic Pediatric Oncology Inpatients.

BACKGROUND: Fever and neutropenia (F&N) is a pediatric oncology emergency due to the risk of disseminated infection. Quality improvement (QI) efforts to improve time to antibiotics for F&N in the emergency department have been documented, but the issue has not been studied in the established inpatient setting. PROCEDURE: We undertook a prospective cohort QI study to decrease time to antibiotics for neutropenic pediatric oncology inpatients with new fever to <60 min. Our key intervention was discussion of a plan in case of new fever, including antibiotic(s) to be started, for each patient on rounds. Timing for each step in the process, from fever identification to antibiotic administration, was measured through the electronic medical record for each fever event. RESULTS: The median time to antibiotics during the 3-three month intervention study period was 76.0 min, although the distribution was skewed due to several long outliers (mean 142.5, interquartile range 51-206, range 47-593 min). Time to antibiotics was significantly shorter when a fever contingency plan was documented in the most recent note than not (mean 102 vs. 254 min, P = 0.039). Over the total 2.75 year data-collection period, the quarterly percentage of patients receiving antibiotics within 60 min has improved from 35 to 65, whereas quarterly mean time to antibiotics has improved from 99 to 50 min. CONCLUSIONS: Daily discussion of a fever contingency plan appears effective in decreasing the time to antibiotics for neutropenic pediatric oncology inpatients with new fever, likely by circumventing the need for multi-level discussion of the antibiotic plan when fever is identified.

Health Literacy and Clinical Outcomes Following Hematopoietic Stem-Cell Transplantation.

PURPOSE: To test associations between health literacy and clinical outcomes in patients undergoing hematopoietic stem-cell transplantation (HSCT). METHODS: English- and Spanish-speaking patients age ≥ 18 years were recruited while admitted for first allogeneic HSCT. Associations between low health literacy (Newest Vital Sign ≤ 3 or Short Test of Functional Health Literacy in Adults ≤ 22) and HSCT outcomes were evaluated. RESULTS: Twenty-eight percent of 177 participants had low health literacy by Newest Vital Sign. None had low health literacy by Short Test of Functional Health Literacy in Adults. There was no statistically significant difference between patients with low and adequate health literacy in hospital readmissions (60% v 54%, P = .4), 2-year overall survival (58% v 66%, P = .19), 2-year cumulative incidence of nonrelapse death (16% v 10%, P = .35), and acute graft-versus-host disease (53% v 44%, P = .3). In multivariable analyses, there were no significant associations between health literacy and clinical outcomes. CONCLUSION: In this cohort of patients undergoing HSCT, we did not identify a relationship between health literacy and clinical outcomes. Although we did not find statistically significant associations between health literacy and HSCT outcomes, interventions to address health literacy should be considered, given complex outpatient care and evidence for adverse outcomes associated with health literacy in similar diseases.