CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
brentuximab vedotin +4 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/NCT01777152
NCT01777152Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas

Seagen Inc.·interventional·Posted Jan 28, 2013·Updated Nov 30, 2021

In Brief

A Phase 3 clinical trial evaluating brentuximab vedotin, doxorubicin, and 3 other interventions for Anaplastic Large-Cell Lymphoma and 2 related conditions. Completed, enrolled 452 participants across 144 sites in 16 countries.

Detailed Summary

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaplastic Large-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma
CountriesAustralia, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartJan 31, 2013
Primary CompletionAug 15, 2018
Study CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 13.4 years ago

Interventions

brentuximab vedotindrug

1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles

doxorubicindrug

50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

prednisonedrug

100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

vincristinedrug

1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles

cyclophosphamidedrug

750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles