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A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT02848248
Recruitment Status : Terminated
First Posted : July 28, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: SGN-CD123A Phase 1

Detailed Description:

This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts:

  1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
  2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels

Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles.

After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A.

For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 6, 2018
Actual Study Completion Date : April 6, 2018


Arm Intervention/treatment
Experimental: SGN-CD123A
SGN-CD123A every 3 weeks
Drug: SGN-CD123A
Intravenous infusion in 3-week cycles




Primary Outcome Measures :
  1. Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later ]
  2. Type, incidence, and severity of laboratory abnormalities [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later ]
  3. Incidence of dose-limiting toxicity [ Time Frame: First cycle of treatment, 3 weeks ]

Secondary Outcome Measures :
  1. Blood concentrations of SGN-CD123A, total antibodies, and metabolites [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later ]
  3. Rate of remission [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later ]
  4. Duration of complete remission [ Time Frame: Up to approximately 1 year ]
  5. Leukemia-free survival [ Time Frame: Up to approximately 1 year ]
  6. Overall survival [ Time Frame: Up to approximately 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
  • Patients may be eligible after only 1 previous regimen if in a high risk category
  • Adequate baseline renal and hepatic function
  • Eastern Cooperative Oncology Group Status of 0 or 1
  • CD123-detectable leukemia

Exclusion Criteria:

  • Cerebral/meningeal disease related to underlying malignancy
  • Promyelocytic leukemia
  • History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted
  • Prior hematopoietic stem cell transplant
  • Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)
  • Cardio or cerebral vascular event within 6 months

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): NCT02848248


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, Colorado
University of Colorado Hospital / University of Colorado
Aurora, Colorado, United States, 80045-0510
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Hudson Valley Hematology and Oncology Associates/New York Medical College
Hawthorne, New York, United States, 10532-2168
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Phoenix Ho, MD Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02848248     History of Changes
Other Study ID Numbers: SGN123-001
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Seattle Genetics, Inc.:
Acute Myeloid Leukemia
Antibody-Drug Conjugate
CD123 Antigen
Drug Therapy
AML
Leukemia, Myeloid, Acute
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms