Back to resultsA Safety Study of SGN-CD19A for Leukemia and Lymphoma
Primary Purpose
Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
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 Burkitt Lymphoma, Antibodies, Monoclonal, Antibody-Drug Conjugate, B-Lineage Acute Lymphoblastic Leukemia, B-Lineage Lymphoblastic Lymphoma, Burkitt Leukemia, Monomethylauristatin F, Antigens, CD19, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
- Eastern Cooperative Oncology Group status of 2 or lower
- Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
- Measurable disease
Exclusion Criteria:
- Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
Sites / Locations
- Children's Hospital of Alabama / University of Alabama at Birmingham
- University of Alabama at Birmingham
- Mayo Clinic Arizona
- City of Hope National Medical Center
- Mayo Clinic Florida
- All Children's Hospital
- H. Lee Moffitt Cancer Center & Research Institute
- Children's Healthcare of Atlanta / Emory University
- Massachusetts General Hospital
- Boston Children's Hospital
- Dana Farber Cancer Institute
- Memorial Sloan Kettering Cancer Center
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-CD19A
Arm Description
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Outcomes
Primary Outcome Measures
Incidence of adverse events
Incidence of laboratory abnormalities
Secondary Outcome Measures
Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
Duration of response
Overall survival
Blood concentrations of SGN-CD19A and metabolites
Incidence of antitherapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01786096
Brief Title
A Safety Study of SGN-CD19A for Leukemia and Lymphoma
Official Title
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 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 adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Keywords
Burkitt Lymphoma, Antibodies, Monoclonal, Antibody-Drug Conjugate, B-Lineage Acute Lymphoblastic Leukemia, B-Lineage Lymphoblastic Lymphoma, Burkitt Leukemia, Monomethylauristatin F, Antigens, CD19, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGN-CD19A
Arm Type
Experimental
Arm Description
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Intervention Type
Drug
Intervention Name(s)
SGN-CD19A
Intervention Description
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
Time Frame
Through 1 month post last dose
Title
Duration of response
Time Frame
Until disease progression or start of new anticancer treatment, an expected average of 3 months
Title
Overall survival
Time Frame
Until death or study closure, an expected average of 6 months
Title
Blood concentrations of SGN-CD19A and metabolites
Time Frame
Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose
Title
Incidence of antitherapeutic antibodies
Time Frame
Predose in most cycles and 1 month post last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
Eastern Cooperative Oncology Group status of 2 or lower
Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
Measurable disease
Exclusion Criteria:
Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Feldman, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Alabama / University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
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
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
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
Children's Healthcare of Atlanta / Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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A Safety Study of SGN-CD19A for Leukemia and Lymphoma
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