A Safety Study of SGN-CD19A for Leukemia and Lymphoma
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
1 other identifier
interventional
92
1 country
13
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).
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
13 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
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2017
CompletedJuly 2, 2017
June 1, 2017
4.3 years
February 5, 2013
June 29, 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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
Through 1 month post last dose
Duration of response
Until disease progression or start of new anticancer treatment, an expected average of 3 months
Overall survival
Until death or study closure, an expected average of 6 months
Blood concentrations of SGN-CD19A and metabolites
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
Incidence of antitherapeutic antibodies
Predose in most cycles and 1 month post last dose
Study Arms (1)
SGN-CD19A
EXPERIMENTALSGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Interventions
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (13)
Children's Hospital of Alabama / University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Children's Healthcare of Atlanta / Emory University
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Feldman, 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
May 30, 2017
Study Completion
May 30, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06