Status:
COMPLETED
A Safety Study of SGN-CD33A in AML Patients
Lead Sponsor:
Seagen Inc.
Conditions:
Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is t...
Detailed Description
This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of ...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia, positive for CD33
- Eastern Cooperative Oncology Group status of 0 or 1
- Adequate baseline renal and hepatic function
- Central venous access
- Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
- Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
Exclusion
- Inadequate lung function
- Prior allogeneic stem cell transplant, except for a specific cohort
- High-dose chemotherapy within 4 weeks of study drug
- Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT01902329
Start Date
July 1 2013
End Date
December 8 2017
Last Update
January 5 2018
Active Locations (14)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
3
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
4
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States, 30322