- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388490
Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas (Bretuximab)
October 31, 2019 updated by: Seoul National University Hospital
A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.
The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
-
Seoul, Korea, Republic of
- SMG-SNU Boramae Medical Center
-
Seoul, Korea, Republic of
- Seoul National Unversity Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with relapsed or refractory EBV- and CD30-positive lymphomas
- Age ≥ 18 years
- ECOG performance status 0-2
- At least one measurable lesion based on revised Cheson's or modified SWAT criteria
- Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
- Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Adequate hematologic function: absolute neutrophil count (ANC) ≥1,500/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC ≥ 1,000/µL and platelet count ≥ 50,000/µL if there is known bone marrow involvement)
- Adequate liver function: total bilirubin < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST < 3 x ULN (AST and AST < 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
- Adequate renal function: serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
- Expected survival > 3 months
Exclusion Criteria:
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
- Any serious medical or psychiatric illness
- Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
- Symptomatic neurologic disease compromising normal activities or requiring medication
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- Known history of myocardial infarction within 1 year, NYHA class III/IV heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
- Any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
- Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
- Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
- Prior exposure to CD30-targeted agents
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
- Another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brentuximab vedotin
Brentuximab vedotin is an antibody-drug conjugate (ADC) composed of the anti-CD30 chimeric immunoglobulin G1 (IgG1) monoclonal antibody cAC10 and the potent antimicrotubule drug monomethyl auristatin E connected by a protease-cleavable linker.
cAC10 binds to the CD30 antigen, which has a very low expression on normal cells but is found on some tumor cells.
|
Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle.
The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the overall response rate (ORR) of brentuximab vedotin in EBV- and CD30-positive lymphomas
Time Frame: One-year
|
ORR using investigator assessments according SWAT
|
One-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety profile of brentuximab vedotin using CTCAE version 4.03
Time Frame: Until 1 month after the last dose of brentuximab vedotin
|
AEs/SAEs as defined by NCI CTCAE version 5.0
|
Until 1 month after the last dose of brentuximab vedotin
|
To calculate progression-free survival (PFS) time
Time Frame: One-year
|
PFS as defined as the time from the date of initiation until the date of first documented progression
|
One-year
|
To calculate the duration of response
Time Frame: One-year
|
6weeks
|
One-year
|
To calculate overall survival (OS) time
Time Frame: One-year
|
OS as defined as the time from the date of first dose until death due to any cause
|
One-year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the CD30-positive rate of EBV-positive lymphomas
Time Frame: One-year
|
Exploratory
|
One-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tae Min Kim, MD, PhD, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2016
Primary Completion (Actual)
April 2, 2019
Study Completion (Actual)
April 2, 2019
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
November 4, 2019
Last Update Submitted That Met QC Criteria
October 31, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X25016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed or Refractory EBV-and CD30-positive Lymphomas
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Anhui Provincial HospitalNot yet recruitingCD19-positive Relapsed or Refractory B-cell MalignanciesChina
-
Yale UniversityMerck Sharp & Dohme LLCTerminatedRelapsed Lymphomas | Refractory LymphomasUnited States
-
Lantern Pharma Inc.RecruitingAdvanced Solid Tumor | Relapsed or Refractory LymphomasUnited States
-
Tayu Huaxia Biotech Medical Group Co., Ltd.RecruitingLocally Advanced /Metastatic Solid Tumors | Relapsed or Refractory LymphomasChina
-
Xin WangUnknownRelapsed or Refractory B-cell LymphomasChina
-
TakedaCompletedRelapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell LymphomaJapan
-
State Budgetary Healthcare Institution, National...UnknownRelapsed/Refractory Malignant LymphomasRussian Federation
-
Sidney Kimmel Comprehensive Cancer Center at Johns...RecruitingRefractory and/or Relapsed Metastatic Solid TumorsUnited States
-
Merck Sharp & Dohme LLCCompletedRelapsed or Refractory Advanced Cancer
-
The First Affiliated Hospital of Soochow UniversityShanghai Unicar-Therapy Bio-medicine Technology Co.,LtdUnknownRefractory Non-Hodgkin Lymphoma | Relapsed Non Hodgkin Lymphoma | CAR - T CD19/CD20/CD22/CD30China
Clinical Trials on brentuximab vedotin
-
Seagen Inc.TerminatedSystemic Lupus ErythematosusUnited States
-
Seagen Inc.Millennium Pharmaceuticals, Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, France
-
University Hospital, CaenRecruiting
-
Washington University School of MedicineSeagen Inc.CompletedMyelodysplastic Syndromes | Leukemia, Acute Myeloid | Leukemia, Lymphoblastic,AcuteUnited States
-
Seagen Inc.Millennium Pharmaceuticals, Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, Germany
-
Fondazione Italiana Linfomi ONLUSCompletedRelapsed/Refractory Hodgkin's LymphomaItaly
-
Seagen Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States
-
Seagen Inc.Millennium Pharmaceuticals, Inc.No longer availableLymphoma, Non-Hodgkin | Lymphoma, T-Cell, Cutaneous | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, United Kingdom, Belgium, Serbia, Australia, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Spain, Switzerland
-
Samsung Medical CenterMillennium Pharmaceuticals, Inc.CompletedNon-Hodgkin LymphomaKorea, Republic of
-
Seagen Inc.Millennium Pharmaceuticals, Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, AnaplasticUnited States, France, Canada, Belgium, United Kingdom