A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
- Conditions
- Acute Myeloid LeukemiaAcute Myelogenous Leukemia
- Interventions
- Registration Number
- NCT02326584
- Lead Sponsor
- Seagen Inc.
- Brief Summary
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.
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
- Eastern Cooperative Oncology Group status of 0 or 1
- Adequate baseline renal and hepatic function
- Central venous access
- Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance
- Previous treatment for MDS or MPN for dose escalation cohorts
- Inadequate lung function
- Inadequate heart function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Consolidation with SGN-CD33A High dose cytarabine for consolidation High dose cytarabine for consolidation + SGN-CD33A (28-day cycles) Induction with SGN-CD33A SGN-CD33A 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A Induction and Consolidation with SGN-CD33A Standard dose cytarabine for induction 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A Induction and Consolidation with SGN-CD33A Daunorubicin 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A Induction with SGN-CD33A Standard dose cytarabine for induction 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A Induction with SGN-CD33A Daunorubicin 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A Consolidation with SGN-CD33A SGN-CD33A High dose cytarabine for consolidation + SGN-CD33A (28-day cycles) Induction and Consolidation with SGN-CD33A High dose cytarabine for consolidation 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A SGN-CD33A Maintenance SGN-CD33A SGN-CD33A Monotherapy (42-day cycles) Induction and Consolidation with SGN-CD33A SGN-CD33A 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
- Primary Outcome Measures
Name Time Method Incidence of adverse events Through 1 month following last dose Incidence of laboratory abnormalities Through 1 month following last dose Incidence of dose-limiting toxicity (DLT) Through 1 month following last dose
- Secondary Outcome Measures
Name Time Method Complete remission (CR) rate at the end of induction Through 1 month following last dose Blood concentrations of SGN-CD33A and metabolites Up to approximately 3 years Incidence of antitherapeutic antibodies (ATA) Up to approximately 3 years Leukemia-free survival Up to approximately 3 years Overall survival Up to approximately 3 years Rate of minimal residual disease (MRD) clearance Up to approximately 3 years
Trial Locations
- Locations (13)
James Cancer Hospital / Ohio State University
🇺🇸Columbus, Ohio, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States