RESUMEN
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.
RESUMEN
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.