The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics and safety of different doses of intravenous and oral Forodesine in children with relapsed or refractory T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma. Preliminary efficacy will also be assessed.
A multi-centre, multi-national, open label trial of Forodesine in children with relapsed or refractory T-cell or B-cell precursor Acute Lymphoblastic Leukaemia or T-cell Non-Hodgkin's Lymphoma. The primary objective of the study is to evaluate the pharmacokinetics and pharmacodynamics of six different dose schedules of Forodesine. Secondary objectives are to evaluate safety and to collect preliminary efficacy data. All patients will receive active drug. The Initial Treatment Phase will last 37 days with a final response assessment on Day 37. Patients who achieve a response may be eligible to receive extended treatment with Forodesine for up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
PK study
Unnamed facility
Vienna, Austria
Unnamed facility
Prague, Czechia
Prof Gerard Michel
Marseille, France
Charite Universitymedicine
Berlin, Germany
Dr Giovanna Gioriani
Pavia, Italy
Sally Kinsey
Leeds, United Kingdom
Pharmacokinetics and pharmacodynamics - data will be collected on Day 1, 5, 8 and 36.
Time frame: Day 1, and 36
Safety data will be collected throughout the study. Efficacy will be assessed on Day 15 and Day 37.
Time frame: Day 15 and 37
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