Publications by authors named "Jaszianne A Tolbert"
Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study.
Thomas Pabst Cristina Papayannidis Fatih Demirkan Vadim Doronin Laura M Fogliatto Jaszianne A Tolbert
Lancet Haematol
November 2023
Article Synopsis
- The study investigated the effectiveness and optimal dosage of cusatuzumab, an anti-CD70 antibody, combined with azacitidine for treating acute myeloid leukaemia in patients not eligible for intensive chemotherapy.
- Conducted across 40 hospitals in seven countries, the randomized trial assigned 103 adult patients to receive either 10 mg/kg or 20 mg/kg doses of cusatuzumab alongside azacitidine in 28-day cycles, aiming to evaluate complete remission rates.
- Although 55% of patients experienced significant treatment results, the study was halted after part one due to changes in the treatment landscape that made continuing with further phases impractical.
Background: A liquid formulation of 6-mercaptopurine (6-MP) was recently approved by the Food and Drug Administration (Purixan®) based on bioavailability (BA) data from healthy adults. We examined the pharmacokinetics (PK) and BA of 6-MP in children with acute lymphoblastic leukemia (ALL) comparing a marketed tablet, two extemporaneously prepared liquid formulations, and data from the approved liquid formulation.
Methods: Twenty-two children (6-17 years) participated in a randomized two-way, crossover study of two cohorts.