A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
1 other identifier
interventional
116
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2014
Typical duration 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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedMay 9, 2018
May 1, 2018
2.2 years
December 18, 2014
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Complete remission (CR) rate at the end of induction
Through 1 month following last dose
Leukemia-free survival
Up to approximately 3 years
Overall survival
Up to approximately 3 years
Blood concentrations of SGN-CD33A and metabolites
Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)
Up to approximately 3 years
- +1 more secondary outcomes
Study Arms (4)
Induction with SGN-CD33A
EXPERIMENTAL7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Consolidation with SGN-CD33A
EXPERIMENTALHigh dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
SGN-CD33A Maintenance
EXPERIMENTALSGN-CD33A Monotherapy (42-day cycles)
Induction and Consolidation with SGN-CD33A
EXPERIMENTAL7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous treatment for MDS or MPN for dose escalation cohorts
- Inadequate lung function
- Inadequate heart function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (13)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, 60153, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cleveland Clinic, The
Cleveland, Ohio, 44195, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, 43210, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 30384, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Feldman, MD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 29, 2014
Study Start
December 1, 2014
Primary Completion
January 30, 2017
Study Completion
April 10, 2018
Last Updated
May 9, 2018
Record last verified: 2018-05