Study Stopped
Terminated by pharmaceutical sponsor - no accrual
Brentuximab Vedotin in CD30 Positive Epstein Barr Virus (EBV) Positive DLBCL of Elderly
Pilot Study of Brentuximab Vedotin in CD30 Positive EBV Positive Diffuse Large B-Cell Lymphomas of the Elderly
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment that might be given.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
Shorter than P25 for not_applicable lymphoma
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
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 25, 2013
July 1, 2013
4 months
August 21, 2012
July 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
The primary efficacy parameter is objective response rate, defined as the proportion of patients with complete response (CR) and partial response (PR). To evaluate the activity of Brentuximab vedotin in patients with refractory/relapsed EDLBCLE using modified International Working Group (IWG) response criteria for malignant lymphoma. Measurable lesions: Lesions that can be measured accurately in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques, or as ≥10 mm with spiral CT scan. Nonmeasurable lesions: Lesions not classified as measurable lesions (longest diameter ≤20 mm with conventional techniques or ≤10 mm with spiral CT scan. Frequencies and percentages will be used to summarize for all response categories. The ORR, our primary endpoint, and its 95 confidence interval will be calculated using the exact binominal method.
36 months
Secondary Outcomes (5)
Time to Response (TTR)
36 months
Duration of Response (DOR)
36 months
Time to Disease Progression
36 months
Progression Free Survival (PFS) Rate
36 months
Overall Survival (OS) Rate
36 months
Study Arms (1)
Brentuximab vedotin Treatment
EXPERIMENTALParticipants will have screening tests up to 4 weeks before study treatment and dosing for up to 48 weeks. Brentuximab vedotin will be given with a dose of 1.8 mg (per kilogram of participant's body weight) intravenously (an IV through their vein) every 21 days, over 30 minutes for 16 cycles. Follow-up assessments will be performed up to 104 weeks (2 years).
Interventions
Brentuximab vedotin will be given intravenously as outlined in treatment arm.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CD30+EBV+DLBCLE (EDLBCLE). Diagnosis will be based on identification of diffuse large cell lymphoma (DLBCL) in biopsy specimens characterized by positivity in the malignant cell population of 2 principal markers:
- CD30 by immunohistochemistry (IHC) and
- Epstein-Barr virus (EBV) by EBER in situ hybridization (ISH)
- Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
- Patients must have progressive, relapsed or refractory disease after:
- At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy)
- Relapsed or failed autologous or allogeneic stem cell transplant.
- Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
- Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
- At least 4 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational non-immunotherapy products with clinical evidence of recovery from any toxicity associated with such treatment
- Must meet the following criteria within 4 days before the first dose of study drug:
- Neutrophils ≥1,000/ul
- Hemoglobin ≥ 8 g/dL
- Platelets≥ 50.0x10\^9 /L
- Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert's Syndrome
- +6 more criteria
You may not qualify if:
- Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: Myocardial infarction and the New York Heart Association (NYHA) Class III or IV heart failure.
- History of another primary malignancy not in remission for at least 3 years; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear
- Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with previously treated and resolved central nervous system (CNS) lymphoma involvement are permitted.
- Prior administration of Brentuximab vedotin
- Corticosteroid monotherapy for lymphoma within 2 weeks of the first dose of study drug
- Radioimmunotherapy administration within 8 weeks before the first dose of study drug
- Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment
- Known hypersensitivity to recombinant proteins, or any component contained in the drug formulation
- Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- Seagen Inc.collaborator
Related Publications (1)
Ryder CB, Saeed H, Hussaini M. Composite Lymphoma with Follicular Lymphoma Transformation to Clonally Related Epstein-Barr Virus (EBV) Positive Diffuse Large B-Cell Lymphoma and EBV-PositiveClassic Hodgkin Lymphoma. Case Rep Hematol. 2023 Nov 8;2023:8833273. doi: 10.1155/2023/8833273. eCollection 2023.
PMID: 38028985DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lubomir Sokol, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
March 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 25, 2013
Record last verified: 2013-07