A Safety Study of SGN-CD33A in AML Patients

This study is currently recruiting participants.
Verified March 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: March 27, 2014
Last verified: March 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
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: Ashley Perry    617-643-8992    aperry11@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: March 27, 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 April 15, 2014