NCT01950364

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma

A Phase 1 Study to Estimate MMAE Metabolites in Human Plasma and Urine in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma Receiving Brentuximab Vedotin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.

Conditions

• Hodgkin Lymphoma
• Anaplastic Large-cell Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
DRUG	Brentuximab vedotin and rifampicin	Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-10-01
• Completion: 2015-06-01
• First posted: 2013-09-25
• Last updated: 2016-05-11
• Results posted: 2016-02-09

Locations

6 sites across 3 countries: Belgium, Lithuania, Spain