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Purpose: Copanlisib, a pan-PI3K inhibitor, has previously shown clinical efficacy and a tolerable safety profile in patients with indolent non-Hodgkin lymphoma. However, the pharmacokinetics, safety, tolerability, and efficacy of copanlisib in Chinese patients have not been reported. Methods: This was a single-arm, open-label, phase I study of copanlisib in Chinese patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). Patients received a single intravenous 60 mg infusion of copanlisib over 1 h on days 1, 8, and 15 of a 28-day cycle, with 1 week of rest. Safety was monitored throughout the study, and plasma copanlisib levels were measured for pharmacokinetic analysis. Tumor response was determined by independent central radiologic review. Results: Sixteen patients were enrolled and 13 were treated with 60 mg of copanlisib for a median of 15.0 weeks. With a Cmax of 566 μg/L and a AUC (0–24) of 1880 μg·h/L following single intravenous infusion, the pharmacokinetic parameters of copanlisib were consistent with that in previous studies, and no accumulation in plasma was observed. Treatment-emergent adverse events were reported for all 13 patients, the most common of which were hyperglycemia (100.0%), hypertension (76.9%), decreased neutrophil count (76.9%), and decreased white blood cell count (69.2%). Seven out of 12 evaluated patients achieved partial response, resulting in an overall response rate of 58.3% Conclusions: Copanlisib was well tolerated in Chinese patients with relapsed or refractory iNHL at the dose of 60 mg and demonstrated encouraging disease control, thus warranting further clinical investigation. Clinical trial registration number: NCT03498430 (April 13, 2018). [ABSTRACT FROM AUTHOR]

Little is known regarding the outcome of lymphoma patients undergoing autologous hematopoietic stem cell transplantation (AHSCT) using inadequate hematopoietic stem cell (HSC) doses. Fifty-six patients were enrolled in the study, and the cohort was subdivided into two groups according to the infusion dose: < 1 × 106/kg (poor HSC group) and 1–2 × 106/kg (unfavorable HSC group). Compared with the unfavorable group, the poor HSC group had a longer median time to neutrophil (13 vs. 11 days, p =.007) and platelet engraftment (17 vs. 13 days, p =.024). CD34+ cell infusion dose of < 1 × 106/kg was the only risk factor for neutrophil and platelet engraftment. The expected 3-year progression-free survival and overall survival rates for the whole cohort were 53% and 66%, and no statistical difference was observed between two groups. In conclusion, inadequate HSC infusion dose did not negatively impact AHSCT patient survival but significantly prolonged the time to hematopoietic engraftment. [ABSTRACT FROM AUTHOR]