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A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

NCT01060904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-12-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Conditions

  • Disease, Hodgkin

Interventions

DRUG

brentuximab vedotin

0.6-1.2 mg/kg IV every 2 weeks

DRUG

doxorubicin

25 mg/m2 IV every 2 weeks

DRUG

vinblastine

6 mg/m2 IV every 2 weeks

DRUG

dacarbazine

375 mg/m2 IV every 2 weeks

DRUG

bleomycin

10 units/m2 IV every 2 weeks

DRUG

brentuximab vedotin

0.9-1.2 mg/kg IV every 2 weeks

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Naomi Hunder, MD · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Canada

Study Locations

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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 NCT01060904 on ClinicalTrials.gov