A Safety Study of SGN-CD33A in AML Patients
Conditions
Acute Myelogenous Leukemia - Acute Myeloid Leukemia - Acute Promyelocytic Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute - Leukemia, Promyelocytic, Acute
Conditions: Keywords
Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Immunotherapy, Drug Therapy, Acute Myelogenous Leukemia, Acute Promyelocytic Leukemia, APL
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HMA Type: Drug
Name: SGN-CD33A Type: Drug
Overall Status
Recruiting
Summary
This study will examine the safety profile of SGN-CD33A administered as a single agent and in combination with a hypomethylating agent (HMA). 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Acute myeloid leukemia, positive for CD33

- Eastern Cooperative Oncology 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 allogeneic stem cell transplant, except for a specific cohort

- High-dose chemotherapy within 4 weeks of study drug

- Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Kinley Hurst - 205-975-9481 - mkhurst@uab.edu
City of Hope National Medical Center
Duarte, California, United States
Status: Recruiting
Contact: Pennie Lam - 626-256-4673 - hilam@coh.org
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Status: Recruiting
Contact: Debra Mimo - 813-745-7362 - Debra.Mimo@moffitt.org
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States
Status: Recruiting
Contact: Kaitlin Sitchenko - 404-778-3663 - kaitlin.sitchenko@emory.edu
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Stacie-Ann Sammott - 617-582-8287 - Stacie-AnnS_Sammott@DFCI.HARVARD.EDU
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Christine Connolly - 617-724-4000 - CCONNOLLY1@PARTNERS.ORG
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Maria Moreno-Rollins - 734-647-2148 - mmorrol@med.umich.edu
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Gillian Velardi - 551-996-5484 - GVelardi@hackensackumc.org
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Eytan Stein - 212-639-3314 - steine@mskcc.org
Cleveland Clinic, The
Cleveland, Ohio, United States
Status: Recruiting
Contact: Cassandra Fincher - 216-445-3795 - finchec@ccf.org
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Status: Recruiting
Contact: Mary Ann Richie - 713-745-4367 - mareese@mdanderson.org
University of Utah
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Daniel Brown - 801-213-4230 - daniel.brown@hci.utah.edu
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Status: Recruiting
Contact: Kaysey Orlowski - 206-667-1997 - korlowsk@fredhutch.org
Start Date
July 2013
Completion Date
September 2016
Sponsors
Seattle Genetics, Inc.
Source
Seattle Genetics, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page