A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
- Registration Number
- NCT02848248
- Lead Sponsor
- Seagen Inc.
- Brief Summary
The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.
- Detailed Description
This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts:
1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels
Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles.
After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A.
For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
- Patients may be eligible after only 1 previous regimen if in a high risk category
- Adequate baseline renal and hepatic function
- Eastern Cooperative Oncology Group Status of 0 or 1
- CD123-detectable leukemia
- Cerebral/meningeal disease related to underlying malignancy
- Promyelocytic leukemia
- History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted
- Prior hematopoietic stem cell transplant
- Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)
- Cardio or cerebral vascular event within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SGN-CD123A SGN-CD123A SGN-CD123A every 3 weeks
- Primary Outcome Measures
Name Time Method Type, incidence, severity, seriousness, and relatedness of adverse events Through 1 month following last dose, or end-of-treatment visit whichever is later Type, incidence, and severity of laboratory abnormalities Through 1 month following last dose, or end-of-treatment visit whichever is later Incidence of dose-limiting toxicity First cycle of treatment, 3 weeks
- Secondary Outcome Measures
Name Time Method Blood concentrations of SGN-CD123A, total antibodies, and metabolites Through 1 month following last dose, or end-of-treatment visit whichever is later Incidence of antitherapeutic antibodies Through 1 month following last dose, or end-of-treatment visit whichever is later Rate of remission Through 1 month following last dose, or end-of-treatment visit whichever is later Duration of complete remission Up to approximately 1 year Leukemia-free survival Up to approximately 1 year Overall survival Up to approximately 1 year
Trial Locations
- Locations (7)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of Colorado Hospital / University of Colorado
🇺🇸Aurora, Colorado, United States
Hudson Valley Hematology and Oncology Associates/New York Medical College
🇺🇸Hawthorne, New York, United States