Back to resultsA Safety Study of SGN-CD19A for B-Cell Lymphoma
Primary Purpose
Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-CD19A
Sponsored by
About this trial
This is an interventional treatment trial for Burkitt Lymphoma focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma, Drug Therapy, Monomethylauristatin F, Follicular Lymphoma Grade 3
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Allogeneic stem cell transplant (SCT)
Sites / Locations
- University of Alabama at Birmingham
- City of Hope National Medical Center
- Stanford Cancer Center
- H. Lee Moffitt Cancer Center & Research Institute
- Memorial Sloan Kettering Cancer Center
- MD Anderson Cancer Center / University of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-CD19A
Arm Description
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Outcomes
Primary Outcome Measures
Incidence of adverse events
Incidence of laboratory abnormalities
Secondary Outcome Measures
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Duration of response
Overall survival
Blood concentration of SGN-CD19A and metabolites
Incidence of antitherapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01786135
Brief Title
A Safety Study of SGN-CD19A for B-Cell Lymphoma
Official Title
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD19, B-Lineage Lymphoblastic Lymphoma, Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, B-Cell Lymphoma, Drug Therapy, Monomethylauristatin F, Follicular Lymphoma Grade 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGN-CD19A
Arm Type
Experimental
Arm Description
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Intervention Type
Drug
Intervention Name(s)
SGN-CD19A
Intervention Description
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month post last dose
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month post last dose
Secondary Outcome Measure Information:
Title
Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
Time Frame
Through up to approximately 6 week post last dose
Title
Duration of response
Time Frame
Until disease progression or start of new anticancer treatment, an expected average of 6 months
Title
Overall survival
Time Frame
Until death or study closure, an expected average of 1 year
Title
Blood concentration of SGN-CD19A and metabolites
Time Frame
Through up to approximately 6 weeks post last dose
Title
Incidence of antitherapeutic antibodies
Time Frame
Through up to approximately 6 weeks post last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Allogeneic stem cell transplant (SCT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Kostic, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of SGN-CD19A for B-Cell Lymphoma
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