Relapsed or Refractory Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.
The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is
being tested to treat children who have relapsed or refractory (r/r) anaplastic large-cell
lymphoma (sALCL) or Hodgkin lymphoma (HL). This study will look at the maximum tolerated dose
and/or recommended phase 2 dose, safety and pharmacokinetics of brentuximab vedotin along
with overall response of people who took brentuximab vedotin.
The study enrolled 36 patients. In the phase 1 portion of the study, 12 participants were
enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, 30-minute IV infusion, Day 1 of every
21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Once the maximum tolerated dose and/or recommended phase 2 dose and pharmacokinetics of
brentuximab vedotin was reached, participants were enrolled by diagnosis into two phase 2
study arms: relapsed or refractory sALCL or relapsed or refractory HL and received
brentuximab vedotin 1.8 mg/kg as 30-minute IV on Day 1 of every 21-day cycle for up to 16
cycles. One participant received a maximum of 20 cycles at the joint discretion of the
sponsor and the investigator for continued clinical benefit.
This multicenter trial is being conducted worldwide. The overall time to participate in this
study is approximately 5 years. Participants made multiple visits to the clinic, and were
contacted by telephone every 12 weeks for 12 months after the end of treatment (EOT) for
progression free survival and then every 6 months until death, study closure, or 2 years
after enrollment of the last participant for overall survival.
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