Skip to main content

Table 1 Timing of sample collection for pharmacokinetics assessment

From: Phase I clinical study of brentuximab vedotin (SGN-35) involving children with recurrent or refractory CD30-positive Hodgkin’s lymphoma or systemic anaplastic large cell lymphoma: rationale, design and methods of BV-HLALCL study: study protocol

Cycle Date Time Permissible range
Cycle 1 Day 1 Before administration ≤ 2 h.
10 min after the completion of administration ± 5 min.
Day 2 24 h after the completion of administration ± 1 h.
Day 4 72 h after the start of administration ± 2 h.
Day 8 168 h after the start of administration ± 3 h.
Day 15 336 h after the start of administration ± 3 h.
Cycle 2 Day 1 Before administration ≤ 2 h.
10 min after the completion of administration ± 5 min.
Day 2 24 h after the completion of administration ± 2 h.
Day 4 72 h after the start of administration ± 2 h.
Day 8 168 h after the start of administration ± 3 h.
Day 15 336 h after the start of administration ± 3 h.
Cycle 3 Day 1   ≤ 2 h.
Safety follow-up
  1. Blood samples for pharmacokinetics assessment should be collected at the following points. In subjects in whom blood collection is considered difficult, blood samples may be collected before administration in each cycle