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Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT01925612 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-06-21

Study results available
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Summary

This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.

The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin.

The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.

Conditions

  • Lymphoma, B-cell
  • Lymphoma, Large B-cell, Diffuse

Interventions

DRUG

brentuximab vedotin

1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles

DRUG

brentuximab vedotin

1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles

DRUG

rituximab

375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

DRUG

vincristine

1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)

DRUG

cyclophosphamide

750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

DRUG

prednisone

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

DRUG

doxorubicin

50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Katherine Ruffner · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • United States
  • Czechia
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925612 on ClinicalTrials.gov