A Safety Study of SGN-CD33A in AML Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01902329
First received: July 15, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

This study will examine the safety profile of SGN-CD33A administered as a single agent. The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD 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-leukemia activity of SGN-CD33A will be assessed.


Condition Intervention Phase
Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Drug: SGN-CD33A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood concentrations of SGN-CD33A and metabolites [ Time Frame: Through 3 weeks after dosing ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Rate of complete remission [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Duration of complete remission [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: July 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-CD33A
SGN-CD33A
Drug: SGN-CD33A
Given intravenously every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute myeloid leukemia, positive for CD33
  • Eastern Cooperative Onocology Group status of 0 or 1
  • Adequate baseline renal and hepatic function
  • Central venous access
  • Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
  • Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients

Exclusion Criteria:

  • Inadequate lung function
  • Prior stem cell transplant
  • High-dose chemotherapy within 4 weeks of study drug
  • Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902329

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Kinley Hurst    205-975-9481    mkhurst@uab.edu   
Principal Investigator: Harry Erba, M.D.         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Pennie Hien Lam    626-256-4673    hilam@coh.org   
Principal Investigator: Anthony Stein         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Debra Mimo    813-745-7362    Debra.Mimo@moffitt.org   
Principal Investigator: Jeffrey Lancet, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colleen Loiselle    617-726-2261    CMLOISELLE@PARTNERS.ORG   
Principal Investigator: Amir Fathi, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eytan Stein    212-639-3314    steine@mskcc.org   
Principal Investigator: Eytan Stein         
United States, Ohio
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
Contact: Cassandra Fincher    216-445-3795    finchec@ccf.org   
Principal Investigator: Anjali Advani, M.D.         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Daryn Flentje    801-213-4230    Daryn.Flentje@hci.utah.edu   
Principal Investigator: Tibor Kovacsovics, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Kaysey Orlowski    206-667-1997    korlowsk@fhcrc.org   
Principal Investigator: Roland Walter, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Samuel Blackman, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01902329     History of Changes
Other Study ID Numbers: SGN33A-001
Study First Received: July 15, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Acute Myeloid Leukemia
Antibody-Drug Conjugate
CD33 Antigen
Immunotherapy
Drug Therapy
Acute Myelogenous Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014