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Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

Primary Purpose

Hodgkin Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brentuximab vedotin
bendamustine
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histopathological diagnosis of classical Hodgkin lymphoma
  • Failed standard front-line therapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

  • Received prior salvage therapy, including radiotherapy
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  • Concurrent use of other investigational agents

Sites / Locations

  • University of Alabama at Birmingham
  • Pacific Hematology Oncology Associates
  • Stanford Cancer Center
  • Oncology Institute of Hope & Innovation, The
  • Colorado Blood Cancer Institute
  • Dana Farber Cancer Institute
  • Mayo Clinic Minnesota
  • University of Nebraska Medical Center
  • Columbia University Medical Center
  • Jewish Hospital, The
  • Case Western Reserve University / University Hospitals Case Medical Center
  • Saint Francis Hospital / Bon Secours
  • Charles A. Sammons Cancer Center / Baylor University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brentuximab Vedotin + Bendamustine

Arm Description

Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles

Outcomes

Primary Outcome Measures

Complete Remission Rate
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
Incidence of Adverse Events (AEs)
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.

Secondary Outcome Measures

Incidence of Dose-limiting Toxicities
Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.
Overall Best Response Rate
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
Duration of Response
The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.
Progression-free Survival
The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.

Full Information

First Posted
June 6, 2013
Last Updated
January 24, 2019
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01874054
Brief Title
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
Official Title
A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease
Keywords
Antibody-Drug Conjugate, Antibodies, Monoclonal, Hodgkin Disease, Hematologic Diseases, Drug Therapy, Immunotherapy, Antigens, CD30, Lymphoma, monomethylauristatin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab Vedotin + Bendamustine
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
bendamustine
Intervention Description
90 mg/m2 on Days 1 and 2 of 3-week cycles
Primary Outcome Measure Information:
Title
Complete Remission Rate
Description
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
Time Frame
Up to 4.6 months
Title
Incidence of Adverse Events (AEs)
Description
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.
Time Frame
Up to 13.8 months
Secondary Outcome Measure Information:
Title
Incidence of Dose-limiting Toxicities
Description
Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.
Time Frame
Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
Title
Overall Best Response Rate
Description
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
Time Frame
Up to 4.6 months
Title
Duration of Response
Description
The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.
Time Frame
Up to 47.8 months
Title
Progression-free Survival
Description
The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Time Frame
Up to 49 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathological diagnosis of classical Hodgkin lymphoma Failed standard front-line therapy Measurable disease of at least 1.5 cm as documented by radiographic technique Eastern Cooperative Oncology Group performance status less than or equal to 2 Exclusion Criteria: Received prior salvage therapy, including radiotherapy Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug Concurrent use of other investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Josephson, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Oncology Institute of Hope & Innovation, The
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Jewish Hospital, The
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Case Western Reserve University / University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Saint Francis Hospital / Bon Secours
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Charles A. Sammons Cancer Center / Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29703778
Citation
LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.
Results Reference
derived

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Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

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