Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02326584
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Myelogenous Leukemia Drug: Standard dose cytarabine for induction Drug: SGN-CD33A Drug: Daunorubicin Drug: High dose cytarabine for consolidation Phase 1

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : April 10, 2018


Arm Intervention/treatment
Experimental: Induction with SGN-CD33A
7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Drug: Standard dose cytarabine for induction
100 mg/m2/day Days 1-7

Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Name: vadastuximab talirine

Drug: Daunorubicin
60 mg/m2/day Days 1-3

Experimental: Consolidation with SGN-CD33A
High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Name: vadastuximab talirine

Drug: High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle

Experimental: SGN-CD33A Maintenance
SGN-CD33A Monotherapy (42-day cycles)
Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Name: vadastuximab talirine

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
Drug: Standard dose cytarabine for induction
100 mg/m2/day Days 1-7

Drug: SGN-CD33A
Given intravenously Day 1 or Days 1 and 4 of each cycle
Other Name: vadastuximab talirine

Drug: Daunorubicin
60 mg/m2/day Days 1-3

Drug: High dose cytarabine for consolidation
3g/m2 on Days 1, 3, and 5 of each cycle




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  3. Incidence of dose-limiting toxicity (DLT) [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Complete remission (CR) rate at the end of induction [ Time Frame: Through 1 month following last dose ]
  2. Leukemia-free survival [ Time Frame: Up to approximately 3 years ]
  3. Overall survival [ Time Frame: Up to approximately 3 years ]
  4. Blood concentrations of SGN-CD33A and metabolites [ Time Frame: Up to approximately 3 years ]
  5. Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 3 years ]
  6. Rate of minimal residual disease (MRD) clearance [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326584


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Illinois
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Ohio
Cleveland Clinic, The
Cleveland, Ohio, United States, 44195
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 30384
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Layout table for investigator information
Study Director: Eric Feldman, MD Seattle Genetics, Inc.
Layout table for additonal information
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02326584    
Other Study ID Numbers: SGN33A-002
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by Seattle Genetics, Inc.:
Acute Myeloid Leukemia
Antibody-Drug Conjugate
CD33 Antigen
Drug Therapy
Acute Myelogenous Leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors