A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
2 other identifiers
interventional
39
2 countries
11
Brief Summary
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2011
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedJune 28, 2017
June 1, 2017
2.2 years
February 25, 2011
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events and laboratory abnormalities
Through 1 month after last dose
Secondary Outcomes (5)
Brentuximab vedotin concentration in blood
Through 1 month after last dose
Antitherapeutic antibodies in blood
Through 1 month after last dose
Best clinical response
Through 1 month after last dose
Progression-free survival
Until disease progression or study closure
Overall survival
Every 3 months until death or study closure
Study Arms (3)
1
EXPERIMENTALSequential
2
EXPERIMENTALCombination
3 Brentuximab vedotin/CH-P
EXPERIMENTALCombination
Interventions
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
Eligibility Criteria
You may qualify if:
- Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
- Measurable disease of at least 1.5 cm
- ECOG performance status less than or equal to 2
You may not qualify if:
- Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
- Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
- History of another primary malignancy that has not been in remission for at least 3 years
- Left ventricular ejection fraction \<45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
- Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
- Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Millennium Pharmaceuticals, Inc.collaborator
Study Sites (11)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
St. Francis Hospital
Greenville, South Carolina, 29601, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4000, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, 98109, United States
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
PMID: 25135998RESULTFanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Uttarwar M, Lee SY, Ren H, Kennedy DA, Shustov AR. Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas. Blood. 2018 May 10;131(19):2120-2124. doi: 10.1182/blood-2017-12-821009. Epub 2018 Mar 5.
PMID: 29507077DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dana Kennedy, PharmD, BCOP
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 25, 2011
First Posted
March 7, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2013
Study Completion
February 28, 2017
Last Updated
June 28, 2017
Record last verified: 2017-06