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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 19 Jan 2023

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At a glance

  • Drugs Brentuximab vedotin (Primary)
  • Indications Anaplastic large cell lymphoma; Hodgkin's disease
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Takeda Oncology

    • Most Recent Events

    • 13 Dec 2022 Results using data from NCT01492088 and NCT02979522 to develop PPK models , identifying factors impacting the pharmacokinetics of ADC and MMAE, and exposure response analyses assessing the risk benefit profiles of brentuximab vedotin combined with chemotherapy, presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 28 Jun 2020 An population PK (POPPK) analysis used data from pediatric (NCT01492088) and adult (NCT00430846) studies of brentuximab vedotin to quantify body size effects on ADC exposure; results published in the Journal of Clinical Pharmacology
    • 26 Apr 2018 Status changed from active, no longer recruiting to completed.

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