NCT01060904

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

January 29, 2010

Last Update Submit

December 17, 2014

Conditions

Disease, Hodgkin

Keywords

Antibodies, MonoclonalAntibody-Drug ConjugateAntigens, CD30Disease, HodgkinHematologic DiseasesImmunotherapyLymphomamonomethyl auristatin E

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and laboratory abnormalities

    Through 1 month after last dose

Secondary Outcomes (3)

  • Brentuximab vedotin concentration in blood

    Through 1 month after last dose

  • Antitherapeutic antibodies in blood

    Through 1 month after last dose

  • Best clinical response

    Through 1 month after last dose

Study Arms (2)

1

EXPERIMENTAL

brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)

Drug: brentuximab vedotinDrug: doxorubicinDrug: vinblastineDrug: dacarbazineDrug: bleomycin

2

EXPERIMENTAL

brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)

Drug: doxorubicinDrug: vinblastineDrug: dacarbazineDrug: brentuximab vedotin

Interventions

brentuximab vedotinDRUG

0.6-1.2 mg/kg IV every 2 weeks

Also known as: SGN-35
1
doxorubicinDRUG

25 mg/m2 IV every 2 weeks

12
vinblastineDRUG

6 mg/m2 IV every 2 weeks

12
dacarbazineDRUG

375 mg/m2 IV every 2 weeks

12
bleomycinDRUG

10 units/m2 IV every 2 weeks

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
  • Measurable disease of at least 1.5 cm
  • Eastern Cooperative Oncology Group performance status \<3

You may not qualify if:

  • History of another primary malignancy that has not been in remission for at least 3 years
  • Known cerebral/meningeal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030, United States

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (1)

  • Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

    PMID: 24239220RESULT

MeSH Terms

Conditions

Hodgkin DiseaseHematologic DiseasesLymphoma

Interventions

Brentuximab VedotinDoxorubicinVinblastineDacarbazineBleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingGlycopeptidesGlycoconjugates

Study Officials

  • Naomi Hunder, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

CA(1)US(3)