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A Safety Study of SGN-CD33A in AML Patients

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: NCT01902329
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Acute Myeloid Leukemia Acute Promyelocytic Leukemia Drug: HMA Drug: SGN-CD33A Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
Study Start Date : July 2013
Actual Primary Completion Date : March 18, 2016
Actual Study Completion Date : December 8, 2017

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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 ]

Secondary Outcome Measures :
  1. Blood concentrations of SGN-CD33A and metabolites [ Time Frame: Through 3 weeks after dosing ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]
  3. Rate of complete remission [ Time Frame: Up to 3 months ]
  4. Duration of complete remission [ Time Frame: Up to approximately 3 years ]
  5. Relapse-free survival [ Time Frame: Up to approximately 3 years ]
  6. Overall survival [ Time Frame: Up to approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01902329


Locations
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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, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic, The
Cleveland, Ohio, United States, 44195
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, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Phoenix Ho, MD Seagen Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT01902329    
Other Study ID Numbers: SGN33A-001
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Keywords provided by Seagen Inc.:
Acute Myeloid Leukemia
Antibody-Drug Conjugate
CD33 Antigen
Immunotherapy
 Drug Therapy
Acute Myelogenous Leukemia
Acute Promyelocytic Leukemia
APL
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Promyelocytic, Acute
 Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases