Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
1 other identifier
interventional
34
1 country
4
Brief Summary
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell. The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab. In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2012
Longer than P75 for phase_2
4 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
First Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 16, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedResults Posted
Study results publicly available
August 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFebruary 20, 2018
January 1, 2018
2.8 years
February 9, 2012
June 7, 2017
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response Rate
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
End of Therapy (median duration of four months)
Secondary Outcomes (3)
Overall Response Rate After One Cycle of Brentuximab
28 days
Overall Response Rate
End of Therapy (median duration of four months)
Grade III or IV Adverse Events
2 years
Study Arms (1)
Treatment Arm
EXPERIMENTALBrentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Interventions
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
Eligibility Criteria
You may qualify if:
- Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease greater than or equal to 1.5 cm
- ECOG performance status of 0 or 2
- Willing to use 2 effective forms of birth control
You may not qualify if:
- No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- Not receiving any other investigational agents
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- No pre-existing grade 3 or greater neuropathy
- No uncontrolled intercurrent illness
- Not pregnant or breastfeeding
- No history of a different malignancy unless disease free for at least one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Beth Israel Deaconess Medical Centercollaborator
- Dana-Farber Cancer Institutecollaborator
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
- Seagen Inc.collaborator
Study Sites (4)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Massachusetts General Hosptial
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Abramson JS, Arnason JE, LaCasce AS, Redd R, Barnes JA, Sokol L, Joyce R, Avigan D, Neuberg D, Takvorian RW, Hochberg EP, Bello CM. Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine for nonbulky limited-stage classical Hodgkin lymphoma. Blood. 2019 Aug 15;134(7):606-613. doi: 10.1182/blood.2019001272. Epub 2019 Jun 11.
PMID: 31186274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeremy Abramson, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Abramson, M.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 16, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2018
Last Updated
February 20, 2018
Results First Posted
August 30, 2017
Record last verified: 2018-01