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

Table 1 Timing of sample collection for pharmacokinetics assessment

Cycle	Date	Time	Permissible range
Cycle 1	Day 1	Before administration	≤ 2 h.
	Day 1	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.
	Day 1	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

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

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