This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
The study will be conducted in the following distinct parts: Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing) Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle). Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles. Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle). Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
100 mg/m2/day Days 1-7
Given intravenously Day 1 or Days 1 and 4 of each cycle
60 mg/m2/day Days 1-3
3g/m2 on Days 1, 3, and 5 of each cycle
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic, The
Cleveland, Ohio, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
...and 3 more locations
Incidence of adverse events
Time frame: Through 1 month following last dose
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose
Incidence of dose-limiting toxicity (DLT)
Time frame: Through 1 month following last dose
Complete remission (CR) rate at the end of induction
Time frame: Through 1 month following last dose
Leukemia-free survival
Time frame: Up to approximately 3 years
Overall survival
Time frame: Up to approximately 3 years
Blood concentrations of SGN-CD33A and metabolites
Time frame: Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Time frame: Up to approximately 3 years
Rate of minimal residual disease (MRD) clearance
Time frame: Up to approximately 3 years
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