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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5. Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5.
Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.
Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
Adverse events, changes from baseline in physical examination and clinical laboratory parameters12-lead ECGAssessment of pharmacokinetic endpoints of 506U78, ara-G and intracellular ara-GTP concentration.
Time frame: Day 21
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement.
Time frame: Day 21
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