Back to resultsA Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Primary Purpose
Hodgkin Lymphoma, Peripheral T Cell Lymphoma, Anaplastic Large Cell Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brentuximab vedotin
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring CD30-expression, sALCL, PTCL, cHL, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
- Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
- Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
- Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
Exclusion Criteria:
- Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
- Existing Grade 2 or higher peripheral neuropathy
- Previously refractory to treatment with brentuximab vedotin
- History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
- History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
- Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
- Active cerebral/meningeal disease
- History of progressive multifocal leukoencephalopathy (PML)
- Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
Sites / Locations
- Pacific Cancer Medical Center
- SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
- Memorial Cancer Institute
- Northwest Oncology and Hematology/AMITA
- Cardinal Bernardin Cancer Center / Loyola University Medical Center
- Norton Cancer Institute
- Tulane University Hospital and Clinic
- University of Maryland
- Karmanos Cancer Institute / Wayne State University
- Saint Louis University
- Comprehensive Cancer Centers of Nevada
- Summit Medical Group
- Medical University of South Carolina/Hollings Cancer Center
- Texas Oncology - Fort Worth
- Texas Oncology - Fort Worth 12th Avenue
- The Center for Cancer and Blood Disorders: Fortworth
- MD Anderson Cancer Center / University of Texas
- Houston Methodist Cancer Center
- Texas Oncology - San Antonio Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brentuximab vedotin
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Number of Participants With Laboratory Abnormalities
Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Secondary Outcome Measures
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Overall Survival (OS)
OS is defined as the time from date of enrollment to date of death due to any cause.
Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)
ORR Per Investigator Assessment According to Modified Lugano Response Criteria
Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
DOR Per Investigator Assessment According to Modified Lugano Response Criteria
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
ORR Per BICR According to Lugano Response Criteria
ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03947255
Brief Title
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Official Title
A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Study stopped early due to low patient accrual.
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
November 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
Detailed Description
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Peripheral T Cell Lymphoma, Anaplastic Large Cell Lymphoma
Keywords
CD30-expression, sALCL, PTCL, cHL, Seattle Genetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brentuximab vedotin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
ADCETRIS, SGN-35
Intervention Description
1.8 mg/kg given intravenously (IV)
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
Description
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Time Frame
Up to 18.3 months
Title
Number of Participants With Adverse Events
Description
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Time Frame
Up to 36 months
Title
Number of Participants With Laboratory Abnormalities
Description
Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
Description
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Time Frame
Up to 17.1 months
Title
Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
Description
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Time Frame
up to 18.3 months
Title
Overall Survival (OS)
Description
OS is defined as the time from date of enrollment to date of death due to any cause.
Time Frame
Up to 35.8 months
Title
Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
Description
CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)
Time Frame
Up to 18.3 months
Title
ORR Per Investigator Assessment According to Modified Lugano Response Criteria
Description
Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
Time Frame
Up to 18.3 months
Title
DOR Per Investigator Assessment According to Modified Lugano Response Criteria
Description
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Time Frame
Up to 17.1 months
Title
Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
Description
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Time Frame
Up to 18.3 months
Title
Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
Description
CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
Time Frame
Up to 18.3 months
Title
ORR Per BICR According to Lugano Response Criteria
Description
ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
Time Frame
Up to 18.3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
Exclusion Criteria:
Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
Existing Grade 2 or higher peripheral neuropathy
Previously refractory to treatment with brentuximab vedotin
History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
Active cerebral/meningeal disease
History of progressive multifocal leukoencephalopathy (PML)
Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Lai, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Memorial Cancer Institute
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Northwest Oncology and Hematology/AMITA
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Medical University of South Carolina/Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology - Fort Worth
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Fort Worth 12th Avenue
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The Center for Cancer and Blood Disorders: Fortworth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
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