A Safety Study of SGN-CD19A for B-Cell Lymphoma
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
1 other identifier
interventional
64
1 country
6
Brief Summary
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2013
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2017
CompletedOctober 19, 2017
June 1, 2017
2.5 years
February 5, 2013
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Through 1 month post last dose
Incidence of laboratory abnormalities
Through 1 month post last dose
Secondary Outcomes (5)
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Through up to approximately 6 week post last dose
Duration of response
Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Until death or study closure, an expected average of 1 year
Blood concentration of SGN-CD19A and metabolites
Through up to approximately 6 weeks post last dose
Incidence of antitherapeutic antibodies
Through up to approximately 6 weeks post last dose
Study Arms (1)
SGN-CD19A
EXPERIMENTALSGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Interventions
Eligibility Criteria
You may qualify if:
- Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
- Eastern Cooperative Oncology Group status of 0 or 1
- Measurable disease
You may not qualify if:
- Allogeneic stem cell transplant (SCT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (6)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Stanford Cancer Center
Stanford, California, 94305, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ana Kostic, MD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2015
Study Completion
February 16, 2017
Last Updated
October 19, 2017
Record last verified: 2017-06