Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Status:
Completed
Trial end date:
2009-07-15
Target enrollment:
Participant gender:
Summary
In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small
patient population. While the small number of patients presents a practical limitation to the
size of a clinical trial, patients whose disease has not responded to or has relapsed after
treatment with multiple prior chemotherapy regimens have no accepted standard therapies
available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese
patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability,
and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize
the contribution of each available patient.