A Safety Study of SGN-CD33A in AML Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01902329
First received: July 15, 2013
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
This study will examine the safety profile of vadastuximab talirine (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.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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: 225
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-CD33A + HMA
SGN-CD33A with hypomethylating agent
Drug: HMA
azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
Drug: SGN-CD33A
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
Other Name: vadastuximab talirine
Experimental: SGN-CD33A Monotherapy
SGN-CD33A
Drug: SGN-CD33A
Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
Other Name: vadastuximab talirine

Detailed Description:

This study will explore SGN-CD33A as a monotherapy and in combination with a hypomethylating agent (HMA; i.e., azacitidine or decitabine). Initial study treatment with SGN-CD33A includes a maximum of 2 cycles of treatment for monotherapy and 4 cycles for combination cohorts. Patients who achieve documented CR or CRi (Monotherapy) or clinical benefit (Combination) during the first part of the study are eligible to continue treatment.

Additional monotherapy cohorts may include patients with relapsed acute promyelocytic leukemia, relapsed patients with nucleophosmin-1 gene mutation (absence of fms-like tyrosine kinase 3 mutation) (NPM1-mutated, FLT-3 wild type), alternate dosing schedules (fractionated dosing on Days 1 and 4), treatment naive patients with AML who declined intensive therapy, and patients who have relapsed after post-allogeneic stem cell transplant.

Patients in the combination cohort will be treated with azacitidine or decitabine per institutional practice prior to SGN-CD33A dosing. Expansion cohorts may be added for further evaluation of safety, pharmacokinetics, pharmacodynamics, and antitumor activity.

  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 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)
  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: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Tedra Hughes       thugh721@uab.edu   
Principal Investigator: Harry Erba, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Brenda Chang    626-256-4673    bchang@coh.org   
Principal Investigator: Anthony Stein, MD         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Nancy Hillgruber    813-745-2071    Nancy.Hillgruber@moffitt.org   
Principal Investigator: Jeffrey Lancet, MD         
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kaitlin Sitchenko    404-778-3663    kaitlin.sitchenko@emory.edu   
Principal Investigator: Anand Jillella, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Naomi Chuckwuk    617-726-2261    nchuckwuk@partners.org   
Principal Investigator: Amir Fathi, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Marc Polanik    617-582-8287    mpolanik@partners.org   
Principal Investigator: Daniel DeAngelo, MD         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Maria Moreno-Rollins    734-647-2148    mmorrol@med.umich.edu   
Principal Investigator: Dale Bixby, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gillian Velardi    551-996-5484    GVelardi@hackensackumc.org   
Principal Investigator: Stefan Faderl, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Eytan Stein    212-639-3314    steine@mskcc.org   
Principal Investigator: Eytan Stein, MD         
United States, Ohio
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
Contact: Chris Goebel    216-448-6440    Goebelc@ccf.org   
Contact: Christopher Estling    216-444-3576    ESTLINC@ccf.org   
Principal Investigator: Anjali Advani, MD         
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz    214-818-8325    erica.goetz@baylorhealth.edu   
Contact: Moshe Levy    214-370-1000    Moshe.Levy@baylorhealth.edu   
Principal Investigator: Moshe Levy         
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Mary Ann Richie    713-745-4367    mareese@mdanderson.org   
Principal Investigator: Farhad Ravandi-Kashani, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Tope Adeyemi    801-585-0303    tope.adeyemi@hci.utah.edu   
Principal Investigator: Tibor Kovacsovics, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Kaysey Orlowski    206-667-1997    korlowsk@fredhutch.org   
Principal Investigator: Roland Walter, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Phoenix Ho, MD 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: January 28, 2016
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
Acute Promyelocytic Leukemia
APL

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

ClinicalTrials.gov processed this record on February 11, 2016