Clinical Trials /

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

NCT02848248

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02848248

Trial Eligibility

Document

Title

  • Brief Title: A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
  • Official Title: A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: SGN123-001
  • NCT ID: NCT02848248

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
SGN-CD123ASGN-CD123A

Purpose

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.

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.

Trial Arms

NameTypeDescriptionInterventions
SGN-CD123AExperimentalSGN-CD123A every 3 weeks
  • SGN-CD123A

Eligibility 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
Maximum Eligible Age:74 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Seagen Inc.

Trial Keywords

  • Acute Myeloid Leukemia
  • Antibody-Drug Conjugate
  • CD123 Antigen
  • Drug Therapy
  • AML
  • Leukemia, Myeloid, Acute

Last Updated

May 14, 2018