- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326584
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
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
California
-
Duarte, California, United States, 91010-3000
- City of Hope National Medical Center
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Cardinal Bernardin Cancer Center / Loyola University Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute / Wayne State University
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic, The
-
Columbus, Ohio, United States, 43210
- James Cancer Hospital / Ohio State University
-
-
Tennessee
-
Nashville, Tennessee, United States, 30384
- Sarah Cannon Research Institute
-
-
Texas
-
Dallas, Texas, United States, 75246
- Charles A. Sammons Cancer Center / Baylor University Medical Center
-
Houston, Texas, United States, 77030-4095
- MD Anderson Cancer Center / University of Texas
-
-
Washington
-
Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Induction with SGN-CD33A
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
|
100 mg/m2/day Days 1-7
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
60 mg/m2/day Days 1-3
|
Experimental: Consolidation with SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
|
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
3g/m2 on Days 1, 3, and 5 of each cycle
|
Experimental: SGN-CD33A Maintenance
SGN-CD33A Monotherapy (42-day cycles)
|
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
|
Experimental: 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
|
100 mg/m2/day Days 1-7
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Names:
60 mg/m2/day Days 1-3
3g/m2 on Days 1, 3, and 5 of each cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events
Time Frame: Through 1 month following last dose
|
Through 1 month following last dose
|
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose
|
Through 1 month following last dose
|
Incidence of dose-limiting toxicity (DLT)
Time Frame: Through 1 month following last dose
|
Through 1 month following last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Complete remission (CR) rate at the end of induction
Time Frame: Through 1 month following last dose
|
Through 1 month following last dose
|
Leukemia-free survival
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Blood concentrations of SGN-CD33A and metabolites
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Incidence of antitherapeutic antibodies (ATA)
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Rate of minimal residual disease (MRD) clearance
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eric Feldman, MD, Seagen Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
Other Study ID Numbers
- SGN33A-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
University of NebraskaNational Cancer Institute (NCI)Active, not recruitingSecondary Acute Myeloid Leukemia | Therapy-Related Acute Myeloid Leukemia | Adult Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
Clinical Trials on Standard dose cytarabine for induction
-
AstraZenecaTerminatedCrohn's Disease | IBDUnited States, Taiwan, Poland, Germany, South Africa
-
AstraZenecaTerminatedUlcerative ColitisItaly, United States, Taiwan, Germany, Poland, Israel, Puerto Rico, Czechia, South Africa, Japan, Korea, Republic of
-
Fuzhou General HospitalCompletedRenal Transplant RejectionChina
-
University Hospital, Clermont-FerrandCompleted
-
wang, jianxiangRecruitingAcute Myeloid Leukemia | CEBPA Double MutationChina
-
Minia UniversityUnknownOvarian Stimulation
-
Assiut UniversityUnknownto Evaluate Letrozole as a Modality for Minimal Ovarian Stimulation in ICSI Cycles .Egypt
-
University of FloridaGateway for Cancer Research; Cellworks Group Inc.WithdrawniCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic SyndromesMyelodysplastic SyndromesUnited States
-
University of Cape TownCompleted
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; Hunan Cancer... and other collaboratorsRecruitingNasopharyngeal Carcinoma | De-escalation TherapyChina