NCT02848248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

July 25, 2016

Last Update Submit

May 8, 2018

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaAntibody-Drug ConjugateCD123 AntigenDrug TherapyAMLLeukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (3)

  • Type, incidence, severity, seriousness, and relatedness of adverse events

    Through 1 month following last dose, or end-of-treatment visit whichever is later

  • Type, incidence, and severity of laboratory abnormalities

    Through 1 month following last dose, or end-of-treatment visit whichever is later

  • Incidence of dose-limiting toxicity

    First cycle of treatment, 3 weeks

Secondary Outcomes (6)

  • Blood concentrations of SGN-CD123A, total antibodies, and metabolites

    Through 1 month following last dose, or end-of-treatment visit whichever is later

  • Incidence of antitherapeutic antibodies

    Through 1 month following last dose, or end-of-treatment visit whichever is later

  • Rate of remission

    Through 1 month following last dose, or end-of-treatment visit whichever is later

  • Duration of complete remission

    Up to approximately 1 year

  • Leukemia-free survival

    Up to approximately 1 year

  • +1 more secondary outcomes

Study Arms (1)

SGN-CD123A

EXPERIMENTAL

SGN-CD123A every 3 weeks

Drug: SGN-CD123A

Interventions

SGN-CD123ADRUG

Intravenous infusion in 3-week cycles

SGN-CD123A

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

University of Colorado Hospital / University of Colorado

Aurora, Colorado, 80045-0510, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hudson Valley Hematology and Oncology Associates/New York Medical College

Hawthorne, New York, 10532-2168, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4095, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

  • Li F, Sutherland MK, Yu C, Walter RB, Westendorf L, Valliere-Douglass J, Pan L, Cronkite A, Sussman D, Klussman K, Ulrich M, Anderson ME, Stone IJ, Zeng W, Jonas M, Lewis TS, Goswami M, Wang SA, Senter PD, Law CL, Feldman EJ, Benjamin DR. Characterization of SGN-CD123A, A Potent CD123-Directed Antibody-Drug Conjugate for Acute Myeloid Leukemia. Mol Cancer Ther. 2018 Feb;17(2):554-564. doi: 10.1158/1535-7163.MCT-17-0742. Epub 2017 Nov 15.

    PMID: 29142066DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Phoenix Ho, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

August 1, 2016

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

US(7)