A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
NCT ID: NCT02326584
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2014-12-31
2018-04-10
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Induction with SGN-CD33A
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Daunorubicin
60 mg/m2/day Days 1-3
Consolidation with SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle
SGN-CD33A Maintenance
SGN-CD33A Monotherapy (42-day cycles)
SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Induction and Consolidation with SGN-CD33A
7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Daunorubicin
60 mg/m2/day Days 1-3
High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle
Interventions
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Standard dose cytarabine for induction
100 mg/m2/day Days 1-7
SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Daunorubicin
60 mg/m2/day Days 1-3
High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inadequate lung function
* Inadequate heart function
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Feldman, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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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
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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SGN33A-002
Identifier Type: -
Identifier Source: org_study_id
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