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

Primary Purpose

Disease, Hodgkin

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

brentuximab vedotin

doxorubicin

vinblastine

dacarbazine

bleomycin

brentuximab vedotin

About this trial

This is an interventional treatment trial for Disease, Hodgkin focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Mayo Clinic
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
MD Anderson Cancer Center / University of Texas
British Columbia Cancer Agency - Vancouver Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities

Secondary Outcome Measures

Brentuximab vedotin concentration in blood

Antitherapeutic antibodies in blood

Best clinical response

Full Information

NCT ID

NCT01060904

First Posted

January 29, 2010

Last Updated

December 17, 2014

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01060904

Brief Title

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

Official Title

A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disease, Hodgkin

Keywords

Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

brentuximab vedotin

Other Intervention Name(s)

SGN-35

Intervention Description

0.6-1.2 mg/kg IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

doxorubicin

Intervention Description

25 mg/m2 IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

vinblastine

Intervention Description

6 mg/m2 IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

dacarbazine

Intervention Description

375 mg/m2 IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

bleomycin

Intervention Description

10 units/m2 IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

brentuximab vedotin

Other Intervention Name(s)

SGN-35

Intervention Description

0.9-1.2 mg/kg IV every 2 weeks

Primary Outcome Measure Information:

Title

Incidence of adverse events and laboratory abnormalities

Time Frame

Through 1 month after last dose

Secondary Outcome Measure Information:

Title

Brentuximab vedotin concentration in blood

Time Frame

Through 1 month after last dose

Title

Antitherapeutic antibodies in blood

Time Frame

Through 1 month after last dose

Title

Best clinical response

Time Frame

Through 1 month after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV Measurable disease of at least 1.5 cm Eastern Cooperative Oncology Group performance status <3 Exclusion Criteria: History of another primary malignancy that has not been in remission for at least 3 years Known cerebral/meningeal disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naomi Hunder, MD

Organizational Affiliation

Seagen Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

MD Anderson Cancer Center / University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

British Columbia Cancer Agency - Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24239220

Citation

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.

Results Reference

result

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

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