CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
brentuximab vedotin +1 moredrug
Likely dose
brentuximab vedotin 1.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01950364
NCT01950364Phase 1Completed
CompareCT.gov

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

Millennium Pharmaceuticals, Inc.·interventional·Posted Sep 25, 2013·Updated May 11, 2016

In Brief

A Phase 1 clinical trial evaluating brentuximab vedotin and Brentuximab vedotin and rifampicin for Hodgkin Lymphoma and Anaplastic Large-cell Lymphoma. Completed, enrolled 20 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin Lymphoma, Anaplastic Large-cell Lymphoma
CountriesBelgium, Lithuania, Spain
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2013
Enrollment StartNov 1, 2013
Primary CompletionOct 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.8 years ago

Interventions

brentuximab vedotindrug

Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.

Brentuximab vedotin and rifampicindrug

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.