Back to resultsA Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Primary Purpose
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard dose cytarabine for induction
SGN-CD33A
Daunorubicin
High dose cytarabine for consolidation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Drug Therapy, Acute Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous treatment for MDS or MPN for dose escalation cohorts
- Inadequate lung function
- Inadequate heart function
Sites / Locations
- University of Alabama at Birmingham
- City of Hope National Medical Center
- Colorado Blood Cancer Institute
- Cardinal Bernardin Cancer Center / Loyola University Medical Center
- Massachusetts General Hospital
- Karmanos Cancer Institute / Wayne State University
- Hackensack University Medical Center
- Cleveland Clinic, The
- James Cancer Hospital / Ohio State University
- Sarah Cannon Research Institute
- Charles A. Sammons Cancer Center / Baylor University Medical Center
- MD Anderson Cancer Center / University of Texas
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Induction with SGN-CD33A
Consolidation with SGN-CD33A
SGN-CD33A Maintenance
Induction and Consolidation with SGN-CD33A
Arm Description
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
SGN-CD33A Monotherapy (42-day cycles)
7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Outcomes
Primary Outcome Measures
Incidence of adverse events
Incidence of laboratory abnormalities
Incidence of dose-limiting toxicity (DLT)
Secondary Outcome Measures
Complete remission (CR) rate at the end of induction
Leukemia-free survival
Overall survival
Blood concentrations of SGN-CD33A and metabolites
Incidence of antitherapeutic antibodies (ATA)
Rate of minimal residual disease (MRD) clearance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02326584
Brief Title
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Official Title
A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
April 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
Keywords
Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Drug Therapy, Acute Myelogenous Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction with SGN-CD33A
Arm Type
Experimental
Arm Description
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Arm Title
Consolidation with SGN-CD33A
Arm Type
Experimental
Arm Description
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
Arm Title
SGN-CD33A Maintenance
Arm Type
Experimental
Arm Description
SGN-CD33A Monotherapy (42-day cycles)
Arm Title
Induction and Consolidation with SGN-CD33A
Arm Type
Experimental
Arm Description
7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Intervention Type
Drug
Intervention Name(s)
Standard dose cytarabine for induction
Intervention Description
100 mg/m2/day Days 1-7
Intervention Type
Drug
Intervention Name(s)
SGN-CD33A
Other Intervention Name(s)
vadastuximab talirine
Intervention Description
Given intravenously Day 1 or Days 1 and 4 of each cycle
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Description
60 mg/m2/day Days 1-3
Intervention Type
Drug
Intervention Name(s)
High dose cytarabine for consolidation
Intervention Description
3g/m2 on Days 1, 3, and 5 of each cycle
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose
Title
Incidence of dose-limiting toxicity (DLT)
Time Frame
Through 1 month following last dose
Secondary Outcome Measure Information:
Title
Complete remission (CR) rate at the end of induction
Time Frame
Through 1 month following last dose
Title
Leukemia-free survival
Time Frame
Up to approximately 3 years
Title
Overall survival
Time Frame
Up to approximately 3 years
Title
Blood concentrations of SGN-CD33A and metabolites
Time Frame
Up to approximately 3 years
Title
Incidence of antitherapeutic antibodies (ATA)
Time Frame
Up to approximately 3 years
Title
Rate of minimal residual disease (MRD) clearance
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Previous treatment for MDS or MPN for dose escalation cohorts
Inadequate lung function
Inadequate heart function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Feldman, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cleveland Clinic, The
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
James Cancer Hospital / Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
30384
Country
United States
Facility Name
Charles A. Sammons Cancer Center / Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
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