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

May 8, 2018 updated by: Seagen Inc.

A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045-0510
        • University of Colorado Hospital / University of Colorado
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • Hawthorne, New York, United States, 10532-2168
        • Hudson Valley Hematology and Oncology Associates/New York Medical College
    • Texas
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center / University of Texas
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Through 1 month following last dose, or end-of-treatment visit whichever is later
Type, incidence, and severity of laboratory abnormalities
Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of dose-limiting toxicity
Time Frame: First cycle of treatment, 3 weeks
First cycle of treatment, 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of antitherapeutic antibodies
Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Through 1 month following last dose, or end-of-treatment visit whichever is later
Rate of remission
Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Through 1 month following last dose, or end-of-treatment visit whichever is later
Duration of complete remission
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Leukemia-free survival
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Overall survival
Time Frame: Up to approximately 1 year
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

April 6, 2018

Study Completion (Actual)

April 6, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN123-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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