A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Brentuximab vedotin | Drug: brentuximab vedotin 1.8 mg/kg given intravenously (IV)
Other Names: |
Outcome Measures
Primary Outcome Measures
- Objective response rate (ORR) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 1 year]
- Number of participants with adverse events [Up to approximately 5 years]
- Number of participants with laboratory abnormalities [Up to approximately 1 year]
Secondary Outcome Measures
- Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]
- Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]
- Overall survival (OS) [Up to approximately 5 years]
- Rate of complete response (CR) per BICR according to modified Lugano response criteria [Up to approximately 1 year]
- ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 1 year]
- DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]
- PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]
- Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) [Up to approximately 5 years]
- ORR per BICR according to Lugano response criteria (Cheson 2014) [Up to approximately 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
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Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
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Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
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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
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Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
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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:
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Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
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Existing Grade 2 or higher peripheral neuropathy
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Previously refractory to treatment with brentuximab vedotin
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History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
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History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
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Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
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Active cerebral/meningeal disease
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History of progressive multifocal leukoencephalopathy (PML)
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pacific Cancer Medical Center | Anaheim | California | United States | 92801 |
2 | SCL Health Good Samaritan Medical Center Cancer Centers of Colorado | Lafayette | Colorado | United States | 80026 |
3 | Memorial Cancer Institute | Pembroke Pines | Florida | United States | 33028 |
4 | Northwest Oncology and Hematology/AMITA | Elk Grove Village | Illinois | United States | 60007 |
5 | Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
6 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
7 | Tulane University Hospital and Clinic | New Orleans | Louisiana | United States | 70112 |
8 | University of Maryland | Baltimore | Maryland | United States | 21201 |
9 | Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | United States | 48201 |
10 | Saint Louis University | Saint Louis | Missouri | United States | 63103 |
11 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
12 | Summit Medical Group | Florham Park | New Jersey | United States | 07932 |
13 | Medical University of South Carolina/Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
14 | Texas Oncology - Fort Worth | Dallas | Texas | United States | 75246 |
15 | Texas Oncology - Fort Worth 12th Avenue | Fort Worth | Texas | United States | 76104 |
16 | The Center for Cancer and Blood Disorders: Fortworth | Fort Worth | Texas | United States | 76104 |
17 | MD Anderson Cancer Center / University of Texas | Houston | Texas | United States | 77030-4095 |
18 | Houston Methodist Cancer Center | Houston | Texas | United States | 77030 |
19 | Texas Oncology - San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Seagen Inc.
Investigators
- Study Director: Dominic Lai, MD, Seagen Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SGN35-028